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

NCT ID: NCT03161158

Last Updated: 2021-05-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-03
• Study Completion Date: 2019-08-26

Brief Summary

This study evaluates whether tailored, peripheral ultrafiltration complementary to low-dose diuretics is associated with a reduction in cardiovascular mortality in 90 days after randomization and heart failure events in 90 days after discharge than usual care including stepped intravenous diuretics in acutely decompensated chronic heart failure with fluid overload (not fully responsive to diuretic therapy).

Detailed Description

The study will evaluate whether stepped, peripheral ultrafiltration complementary to low-dose diuretics influences 90-day clinical outcomes compared to usual care including intravenous diuretics in symptomatic heart failure patients with persistent congestion. Hospitalized subjects will be randomly assigned to receive either a tailored, peripheral ultrafiltration approach complementary to intravenous low-dose diuretics and other guideline-directed medical therapy OR high-dose diuretic therapy and other Guideline-directed medical therapy.

Conditions

Heart Failure; Acute Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ultrafiltration Group

Veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm.

Group Type: ACTIVE_COMPARATOR

CHIARA-System

Intervention Type: DEVICE

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.

Group Type: OTHER

Usual care IV diuretics

Intervention Type: OTHER

Guideline-directed therapy including IV loop diuretics (according to treatment algorithm)

Interventions

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.

Intervention Type: DEVICE

Usual care IV diuretics

Guideline-directed therapy including IV loop diuretics (according to treatment algorithm)

Intervention Type: OTHER

Other Intervention Names

Low-dose IV diuretics

Eligibility Criteria

Inclusion Criteria

General:

Informed consent signed and dated by study patient and investigator/authorised physician

• Minimum age of 18 years
• Ability to understand the nature and requirements of the study

Study-specific:

• Heart failure patients with preserved, mid-range or reduced ejection fraction (confirmed according to the current definitions of heart failure with preserved (HFpEF), mid-range (HFmrEF) and reduced ejection fraction (HFrEF) requiring echocardiographic assessment within the prior 12 months) who are admitted to the hospital due to signs/symptoms of congestion (left- or right sided)
• On regularly scheduled oral loop diuretics prior to admission
• Patients who have received IV loop diuretics for decongestion within 24 hours after hospital admission and prior to screening. The dosages are administered according to clinical judgment.** (**This inclusion criterion was changed with CIP amendment; in former version 3.0 it read "After pre-screening and prior to final screening for eligibility, patients who have received two boluses of IV loop diuretics (Dose according to the Furosemide-Low Intensification, Q12 hour bolus arm of the DOSE trial))
• Symptoms of congestion and clinical evidence at the time of final screening for eligibility:
• Fluid overload manifested by at least 2 of the following:

1. Pitting edema ≥2+ of the lower extremities

2. Jugular venous pressure >8 cm H2O

3. Pulmonary congestion or pleural effusion on chest x-ray

4. Paroxysmal nocturnal dyspnea or ≥2- pillow orthopnea

5. Respiration rate ≥20 per minute

• Additional objective documentation of congestion: Lung or inferior vena cava ultrasound, chest x-ray or elevated filling pressures, if available, at the time of randomization (optional)

Exclusion Criteria

General:

• Any condition which could interfere with the patient's ability to comply with the study
• In case of female patients, pregnancy or lactation period
• Participation in an interventional clinical study during the preceding 30 days
• Previous participation in the same study
• Unwillingness or inability to complete follow up
• Active drug or alcohol abuse (smoking allowed)

Study-specific:

• Acute coronary syndrome requiring intervention during index hospitalization
• Severe renal dysfunction requiring renal replacement therapy
• Systolic blood pressure < 90 mmHg at the time of randomization
• Pulmonary hypertension not secondary to left heart disease
• Pulmonary disease thought to be primarily responsible for symptoms
• Contraindication to systemic anticoagulation
• Severe concomitant disease expected to prolong hospitalization or to cause death in ≤ 90 days
• Sepsis
• Severe uncorrected valvular stenosis at the time of randomization
• Active myocarditis
• Hypertrophic obstructive cardiomyopathy
• Constrictive pericarditis or restrictive cardiomyopathy
• Liver cirrhosis due to primary liver disease* (*Restriction "due to primary liver disease" was present after amendment in study protocol version 5.0 but not in version 3.0)
• Known infection with human immunodeficiency virus (HIV) or active hepatitis C
• Previous solid organ transplant
• Presence or requirement for mechanical respiratory support
• Presence or requirement of a mechanical circulatory support device
• Need for IV positive inotropic agents at the time of randomization

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fresenius Medical Care Deutschland GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frank Ruschitzka, Prof Dr med

Role: STUDY_CHAIR

Universitätsspital Zürich, Klinik für Kardiologie

Locations

Universitätsklinikum Aachen (Med. Klinik II)

Aachen, , Germany

Helios Klinikum Duisburg

Duisburg, , Germany

Helios Klinikum Erfurt GmbH

Erfurt, , Germany

Medizinische Universitätsklinik, Innere Medizin III

Heidelberg, , Germany

Helios Klinikum Hildesheim GmbH

Hildesheim, , Germany

Klinikum Stuttgart, Klinik für Nieren-, Hochdruck- und Autoimmunerkrankungen

Stuttgart, , Germany

Falun Hospital

Falun, , Sweden

Universitetssjukhuset Örebro, Hjärtsviktsmottagningen

Örebro, , Sweden

Danderyds University Hospital

Stockholm, , Sweden

Karolinska University Hospital Huddinge, Department of Cardiology

Stockholm, , Sweden

Uppsala University Hospital, Department of Cardiology

Uppsala, , Sweden

Countries

Germany; Sweden

References

Srivastava M, Harrison N, Caetano AFS, Tan AR, Law M. Ultrafiltration for acute heart failure. Cochrane Database Syst Rev. 2022 Jan 21;1(1):CD013593. doi: 10.1002/14651858.CD013593.pub2.

Reference Type: DERIVED

PMID: 35061249 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EUDAMED-No. CIV -17-01-018204

Identifier Type: OTHER

Identifier Source: secondary_id

UF-HF-02-INT

Identifier Type: -

Identifier Source: org_study_id