Trial Outcomes & Findings for PURE-HF: Peripheral Ultrafiltration for the RElief From Congestion in Heart Failure (NCT NCT03161158)

Last Updated: 2021-05-05

Results Overview

Heart failure hospitalization or unscheduled outpatient or emergency department treatment with IV loop diuretics or ultrafiltration.

Recruitment status

TERMINATED

Study phase

Target enrollment

62 participants

Primary outcome timeframe

in 90 days after discharge

Results posted on

2021-05-05

Participant Flow

Of 62 enrolled patients, 44 were randomized to treatment. 37 patients were included in the safety and full analysis set (SAF/FAS)

Participant milestones

Participant milestones
Measure	Ultrafiltration Group Veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm. CHIARA-System: Treatment with veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm. 1-7 Ultrafiltration sessions (6-10h/session, number of sessions depending on clinical assessment) for at least 1-2 consecutive days and a maximum of 7 days.	Control Group (Usual Care IV Diuretics) Guideline-directed therapy including IV loop diuretics according to treatment algorithm. Usual care IV diuretics: Guideline-directed therapy including IV loop diuretics (according to treatment algorithm)
Overall Study STARTED	18	19
Overall Study COMPLETED	9	13
Overall Study NOT COMPLETED	9	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PURE-HF: Peripheral Ultrafiltration for the RElief From Congestion in Heart Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ultrafiltration Group n=18 Participants Veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm. CHIARA-System: Treatment with veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm. 1-7 Ultrafiltration sessions (6-10h/session, number of sessions depending on clinical assessment) for at least 1-2 consecutive days and a maximum of 7 days.	Control Group (Usual Care IV Diuretics) n=19 Participants Guideline-directed therapy including IV loop diuretics according to treatment algorithm. Usual care IV diuretics: Guideline-directed therapy including IV loop diuretics (according to treatment algorithm)	Total n=37 Participants Total of all reporting groups
Age, Continuous	71.5 years STANDARD_DEVIATION 9.45 • n=5 Participants	74.2 years STANDARD_DEVIATION 12.40 • n=7 Participants	72.9 years STANDARD_DEVIATION 11 • n=5 Participants
Age, Customized <45 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Customized ≥ 45 to <65 years	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Age, Customized ≥65 years	12 Participants n=5 Participants	16 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Height	173.4 cm STANDARD_DEVIATION 7.80 • n=5 Participants	172.3 cm STANDARD_DEVIATION 13.28 • n=7 Participants	172.8 cm STANDARD_DEVIATION 10.83 • n=5 Participants
Weight	106.4 kg STANDARD_DEVIATION 33.17 • n=5 Participants	95.6 kg STANDARD_DEVIATION 27.42 • n=7 Participants	100.9 kg STANDARD_DEVIATION 30.42 • n=5 Participants
Body-Mass-Index (BMI) ≥18.5 to <25 kg/m^2	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Body-Mass-Index (BMI) ≥25 to <30 kg/m^2	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Body-Mass-Index (BMI) ≥30 to <35	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Body-Mass-Index (BMI) ≥35 to <40 kg/m^2	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Body-Mass-Index (BMI) ≥40 kg/m^2	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Systolic Blood Pressure (SBP)	117.6 mmHg STANDARD_DEVIATION 26.23 • n=5 Participants	128.5 mmHg STANDARD_DEVIATION 29.84 • n=7 Participants	123.2 mmHg STANDARD_DEVIATION 28.30 • n=5 Participants
Diastolic Blood Pressure (DBP)	68.4 mmHg STANDARD_DEVIATION 10.62 • n=5 Participants	70.4 mmHg STANDARD_DEVIATION 14.68 • n=7 Participants	69.4 mmHg STANDARD_DEVIATION 12.73 • n=5 Participants
Heart rate	73.2 bpm STANDARD_DEVIATION 20.32 • n=5 Participants	71.9 bpm STANDARD_DEVIATION 14.57 • n=7 Participants	72.5 bpm STANDARD_DEVIATION 17.28 • n=5 Participants
New York Heart Association (NYHA) Functional Classification NYHA I	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
New York Heart Association (NYHA) Functional Classification NYHA II	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
New York Heart Association (NYHA) Functional Classification NYHA III	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
New York Heart Association (NYHA) Functional Classification NYHA IV	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
New York Heart Association (NYHA) Functional Classification Missing	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: in 90 days after discharge

Heart failure hospitalization or unscheduled outpatient or emergency department treatment with IV loop diuretics or ultrafiltration.

Outcome measures

Outcome measures
Measure	Ultrafiltration Group n=18 Participants Veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm. CHIARA-System: Treatment with veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm. 1-7 Ultrafiltration sessions (6-10h/session, number of sessions depending on clinical assessment) for at least 1-2 consecutive days and a maximum of 7 days.	Control Group (Usual Care IV Diuretics) n=19 Participants Guideline-directed therapy including IV loop diuretics according to treatment algorithm. Usual care IV diuretics: Guideline-directed therapy including IV loop diuretics (according to treatment algorithm)
Heart Failure (HF) Event	4 Participants	4 Participants

PRIMARY outcome

Timeframe: in 90 days after discharge

The rationale for the follow up time period of 90 days is that death rates reported in previous acute HF trials indicate that mortality seems to become linear after \~60-90 days post discharge Collection for Cardiovascular Trials initiative definition of cardiovascular death includes death resulting from an acute myocardial infarction, sudden cardiac death, death due to heart failure, death due to stroke, and death due to other cardiovascular causes

Outcome measures

Outcome measures
Measure	Ultrafiltration Group n=18 Participants Veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm. CHIARA-System: Treatment with veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm. 1-7 Ultrafiltration sessions (6-10h/session, number of sessions depending on clinical assessment) for at least 1-2 consecutive days and a maximum of 7 days.	Control Group (Usual Care IV Diuretics) n=19 Participants Guideline-directed therapy including IV loop diuretics according to treatment algorithm. Usual care IV diuretics: Guideline-directed therapy including IV loop diuretics (according to treatment algorithm)
Cardiovascular Death up to 90 Days After Randomization.	4 Participants	1 Participants

Adverse Events

Ultrafiltration Group

Serious events: 15 serious events

Other events: 12 other events

Deaths: 7 deaths

Control Group (Usual Care IV Diuretics)

Serious events: 13 serious events

Other events: 14 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Jennifer Braun

Fresenius Medical Care Deutschland GmbH

Phone: +49 6172 609 93488

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Serious adverse events
Measure	Ultrafiltration Group n=18 participants at risk Veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm. CHIARA-System: Treatment with veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm. 1-7 Ultrafiltration sessions (6-10h/session, number of sessions depending on clinical assessment) for at least 1-2 consecutive days and a maximum of 7 days.	Control Group (Usual Care IV Diuretics) n=19 participants at risk Guideline-directed therapy including IV loop diuretics according to treatment algorithm. Usual care IV diuretics: Guideline-directed therapy including IV loop diuretics (according to treatment algorithm)
Cardiac disorders Cardiac Failure	33.3% 6/18 • Number of events 6 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	21.1% 4/19 • Number of events 7 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Cardiac disorders Atrioventricular	5.6% 1/18 • Number of events 1 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Cardiac disorders Cardiac failure	5.6% 1/18 • Number of events 1 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Cardiac disorders Cardiogenic shock	5.6% 1/18 • Number of events 1 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Cardiac disorders Cardiovascular	5.6% 1/18 • Number of events 1 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Cardiac disorders Sinoatrial block	5.6% 1/18 • Number of events 1 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Cardiac disorders Ventricular	0.00% 0/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	5.3% 1/19 • Number of events 1 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Renal and urinary disorders Acute kidney	11.1% 2/18 • Number of events 2 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	10.5% 2/19 • Number of events 2 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Renal and urinary disorders Renal failure	0.00% 0/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	10.5% 2/19 • Number of events 2 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Renal and urinary disorders Nephrotic	5.6% 1/18 • Number of events 1 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Infections and infestations Pneumonia	11.1% 2/18 • Number of events 2 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Infections and infestations Erysipelas	5.6% 1/18 • Number of events 1 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Infections and infestations Staphylococcal	5.6% 1/18 • Number of events 1 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
General disorders Death	11.1% 2/18 • Number of events 2 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	5.3% 1/19 • Number of events 1 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Injury, poisoning and procedural complications Contusion	0.00% 0/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	5.3% 1/19 • Number of events 1 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Injury, poisoning and procedural complications Rib fracture	0.00% 0/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	5.3% 1/19 • Number of events 1 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Injury, poisoning and procedural complications Vascular	5.6% 1/18 • Number of events 1 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Metabolism and nutrition disorders Dehydration	5.6% 1/18 • Number of events 1 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Metabolism and nutrition disorders Fluid overload	5.6% 1/18 • Number of events 1 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Nervous system disorders Dementia	0.00% 0/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	5.3% 1/19 • Number of events 1 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Nervous system disorders Syncope	5.6% 1/18 • Number of events 1 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Psychiatric disorders Delirium	0.00% 0/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	5.3% 1/19 • Number of events 1 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Psychiatric disorders Suicide attempt	0.00% 0/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	5.3% 1/19 • Number of events 1 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Surgical and medical procedures Catheter	5.6% 1/18 • Number of events 1 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Surgical and medical procedures Stent placement	0.00% 0/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	5.3% 1/19 • Number of events 1 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Gastrointestinal disorders Abdominal wall	5.6% 1/18 • Number of events 1 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Investigations Echocardiogram	5.6% 1/18 • Number of events 1 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Investigations Oxygen saturation	5.6% 1/18 • Number of events 1 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Musculoskeletal and connective tissue disorders Arthritis	5.6% 1/18 • Number of events 1 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	5.3% 1/19 • Number of events 1 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Product Issues Device dislocation	5.6% 1/18 • Number of events 1 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Respiratory, thoracic and mediastinal disorders Pneumothorax	5.6% 1/18 • Number of events 1 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Social circumstances Loss of personal	0.00% 0/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	5.3% 1/19 • Number of events 1 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."

Other adverse events
Measure	Ultrafiltration Group n=18 participants at risk Veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm. CHIARA-System: Treatment with veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm. 1-7 Ultrafiltration sessions (6-10h/session, number of sessions depending on clinical assessment) for at least 1-2 consecutive days and a maximum of 7 days.	Control Group (Usual Care IV Diuretics) n=19 participants at risk Guideline-directed therapy including IV loop diuretics according to treatment algorithm. Usual care IV diuretics: Guideline-directed therapy including IV loop diuretics (according to treatment algorithm)
General disorders Oedema peripheral	11.1% 2/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	5.3% 1/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
General disorders Pyrexia	5.6% 1/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	10.5% 2/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
General disorders Cyst	0.00% 0/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	5.3% 1/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
General disorders Injection site pain	0.00% 0/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	5.3% 1/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
General disorders Therapeutic product ineffective	5.6% 1/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
General disorders Vessel puncture site haematoma	5.6% 1/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Cardiac disorders Cardiac failure	5.6% 1/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	21.1% 4/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Cardiac disorders Atrial fibrillation	0.00% 0/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	5.3% 1/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Cardiac disorders Bradycardia	0.00% 0/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	5.3% 1/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Cardiac disorders Bundle branch block left	0.00% 0/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	5.3% 1/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Cardiac disorders Cardiac failure congestive	5.6% 1/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.6% 1/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	10.5% 2/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.6% 1/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	5.6% 1/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Respiratory, thoracic and mediastinal disorders Emphysema	0.00% 0/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	5.3% 1/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	5.3% 1/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	5.6% 1/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	5.3% 1/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Renal and urinary disorders Renal failure	0.00% 0/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	15.8% 3/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Renal and urinary disorders Chronic kidney disease	5.6% 1/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	5.3% 1/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Renal and urinary disorders Haematuria	0.00% 0/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	5.3% 1/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Renal and urinary disorders Urinary Incontinence	5.6% 1/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Renal and urinary disorders Urinary retention	0.00% 0/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	5.3% 1/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Vascular disorders Hypotension	16.7% 3/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	10.5% 2/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Vascular disorders Haematoma	5.6% 1/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Vascular disorders Peripheral arterial occlusive disease	5.6% 1/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Vascular disorders Thrombophlebitis	5.6% 1/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Injury, poisoning and procedural complications Fall	0.00% 0/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	5.3% 1/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Injury, poisoning and procedural complications Post procedural haematoma	5.6% 1/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Injury, poisoning and procedural complications Skin laceration	0.00% 0/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	5.3% 1/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Injury, poisoning and procedural complications Vascular access complication	5.6% 1/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Infections and infestations Wound	5.6% 1/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Infections and infestations Pneumonia	11.1% 2/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	5.3% 1/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Infections and infestations Escherichia infection	0.00% 0/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	5.3% 1/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Infections and infestations Escherichia urinary tract infection	0.00% 0/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	5.3% 1/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Metabolism and nutrition disorders Arthralgia	5.6% 1/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	5.3% 1/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Metabolism and nutrition disorders Back pain	11.1% 2/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Metabolism and nutrition disorders Flank pain	5.6% 1/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Metabolism and nutrition disorders Musculoskeletal pain	5.6% 1/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."
Metabolism and nutrition disorders Pain in extremity	5.6% 1/18 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."	0.00% 0/19 • Per patient adverse events were collected from signed informed consent until max 30 days after last clinical Investigation visit. Adverse Event Definition and Collection has been according to ISO 14 155 "Clinical investigation of medical devices for human subjects - Good clinical practice."