Trial Outcomes & Findings for Subcutaneous Furosemide in Acute Decompensated Heart Failure Pilot (NCT NCT02877095)
NCT ID: NCT02877095
Last Updated: 2019-03-15
Results Overview
The analysis of data from the Pilot Phase will be primarily descriptive in nature and there will be no formal hypothesis testing. Number of patients with events will be reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
14 days
Results posted on
2019-03-15
Participant Flow
Participant milestones
| Measure |
In-patient Pilot
All subjects in the in-patient study will receive the subcutaneous pump to administer a special formulation of furosemide to be delivered subcutaneously.
Furosemide: subcutaneous furosemide delivered via subcutaneous pump
|
Out-patient Pilot Study
All subjects in the out-patient study will receive the subcutaneous pump to administer a special formulation of furosemide to be delivered subcutaneously.
Furosemide: subcutaneous furosemide delivered via subcutaneous pump
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Subcutaneous Furosemide in Acute Decompensated Heart Failure Pilot
Baseline characteristics by cohort
| Measure |
In-patient Pilot Study
n=20 Participants
All subjects in the in-patient pilot study will receive the subcutaneous pump to administer a special formulation of furosemide to be delivered subcutaneously.
Furosemide: subcutaneous furosemide delivered via subcutaneous pump
|
Out-patient Pilot Study
n=20 Participants
All subjects in the out-patient study will receive the subcutaneous pump to administer a special formulation of furosemide to be delivered subcutaneously.
Furosemide: subcutaneous furosemide delivered via subcutaneous pump
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.2 years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
57.8 years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
63.0 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 daysThe analysis of data from the Pilot Phase will be primarily descriptive in nature and there will be no formal hypothesis testing. Number of patients with events will be reported.
Outcome measures
| Measure |
In-patient Pilot
n=20 Participants
All subjects in the pilot study will receive the subcutaneous pump to administer a special formulation of furosemide to be delivered subcutaneously.
Furosemide: subcutaneous furosemide delivered via subcutaneous pump
|
Out-patient Pilot Study
n=20 Participants
All subjects in the pilot study will receive the subcutaneous pump to administer a special formulation of furosemide to be delivered subcutaneously.
Furosemide: subcutaneous furosemide delivered via subcutaneous pump
|
|---|---|---|
|
Overall Safety of a Strategy Based on Subcutaneous Delivery of Furosemide in Inpatients and Outpatients as Measured by Number of Adverse Events
Patients with any Adverse Events
|
4 participants
|
9 participants
|
|
Overall Safety of a Strategy Based on Subcutaneous Delivery of Furosemide in Inpatients and Outpatients as Measured by Number of Adverse Events
Patients with no Events
|
16 participants
|
11 participants
|
Adverse Events
In-patient Pilot Study
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Out-patient Pilot Study
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
In-patient Pilot Study
n=20 participants at risk
All subjects in the in-patient study will receive the subcutaneous pump to administer a special formulation of furosemide to be delivered subcutaneously.
Furosemide: subcutaneous furosemide delivered via subcutaneous pump
|
Out-patient Pilot Study
n=20 participants at risk
All subjects in the out-patient study will receive the subcutaneous pump to administer a special formulation of furosemide to be delivered subcutaneously.
Furosemide: subcutaneous furosemide delivered via subcutaneous pump
|
|---|---|---|
|
Infections and infestations
Implant site infection
|
0.00%
0/20 • 1 year
|
5.0%
1/20 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
In-patient Pilot Study
n=20 participants at risk
All subjects in the in-patient study will receive the subcutaneous pump to administer a special formulation of furosemide to be delivered subcutaneously.
Furosemide: subcutaneous furosemide delivered via subcutaneous pump
|
Out-patient Pilot Study
n=20 participants at risk
All subjects in the out-patient study will receive the subcutaneous pump to administer a special formulation of furosemide to be delivered subcutaneously.
Furosemide: subcutaneous furosemide delivered via subcutaneous pump
|
|---|---|---|
|
General disorders
Injection Site Pain
|
10.0%
2/20 • Number of events 2 • 1 year
|
10.0%
2/20 • Number of events 2 • 1 year
|
|
General disorders
Injection Site discomfort
|
5.0%
1/20 • Number of events 1 • 1 year
|
5.0%
1/20 • Number of events 1 • 1 year
|
|
General disorders
Injection site erythema
|
0.00%
0/20 • 1 year
|
5.0%
1/20 • Number of events 1 • 1 year
|
|
General disorders
Injection site haemorhage
|
0.00%
0/20 • 1 year
|
5.0%
1/20 • Number of events 1 • 1 year
|
|
General disorders
Injection Site Rash
|
0.00%
0/20 • 1 year
|
5.0%
1/20 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/20 • 1 year
|
5.0%
1/20 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/20 • 1 year
|
5.0%
1/20 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.00%
0/20 • 1 year
|
5.0%
1/20 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • Number of events 1 • 1 year
|
0.00%
0/20 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/20 • 1 year
|
5.0%
1/20 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
0.00%
0/20 • 1 year
|
5.0%
1/20 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/20 • 1 year
|
5.0%
1/20 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/20 • 1 year
|
5.0%
1/20 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
0.00%
0/20 • 1 year
|
5.0%
1/20 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/20 • 1 year
|
5.0%
1/20 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/20 • 1 year
|
5.0%
1/20 • Number of events 1 • 1 year
|
Additional Information
Rachel Olson, Project Leader
Duke Clinical Research Institute
Phone: 919-309-5544
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place