Trial Outcomes & Findings for Subcutaneous Furosemide in Acute Decompensated Heart Failure: The SUBQ-HF Study (NCT NCT03170219)
NCT ID: NCT03170219
Last Updated: 2019-01-23
Results Overview
measured by serious adverse events
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
30 days
Results posted on
2019-01-23
Participant Flow
Participant milestones
| Measure |
Subcutaneous Furosemide and sc2wear Device
Subjects will receive device training and study materials (SQ pump device and up to a 7 day supply of SQ furosemide vials) on the day of randomization (study day 0) and discharged within 24 hours. Subjects will be discharged with planned treatment of 80 mg subcutaneous furosemide injection over 5-hours either QD or BID, depending on anticipated diuretic requirements.
subcutaneous furosemide and sc2wear device: subcutaneous furosemide administered via sc2wear device vs. standard of care
|
Usual Care
Subjects randomized to usual care will continue to receive inpatient therapy, eventual transition to oral diuretics, and discharge and post discharge care as per the discretion of the treating clinician and standard treatment guidelines.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
4
|
|
Overall Study
COMPLETED
|
7
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Subcutaneous Furosemide in Acute Decompensated Heart Failure: The SUBQ-HF Study
Baseline characteristics by cohort
| Measure |
Subcutaneous Furosemide and sc2wear Device
n=7 Participants
Subjects will receive device training and study materials (SQ pump device and up to a 7 day supply of SQ furosemide vials) on the day of randomization (study day 0) and discharged within 24 hours. Subjects will be discharged with planned treatment of 80 mg subcutaneous furosemide injection over 5-hours either QD or BID, depending on anticipated diuretic requirements.
subcutaneous furosemide and sc2wear device: subcutaneous furosemide administered via sc2wear device vs. standard of care
|
Usual Care
n=4 Participants
Subjects randomized to usual care will continue to receive inpatient therapy, eventual transition to oral diuretics, and discharge and post discharge care as per the discretion of the treating clinician and standard treatment guidelines.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
64.3 years
STANDARD_DEVIATION 6.4 • n=7 Participants
|
62.2 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 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
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysmeasured by serious adverse events
Outcome measures
| Measure |
Subcutaneous Furosemide and sc2wear Device
n=7 Participants
Subjects will receive device training and study materials (SQ pump device and up to a 7 day supply of SQ furosemide vials) on the day of randomization (study day 0) and discharged within 24 hours. Subjects will be discharged with planned treatment of 80 mg subcutaneous furosemide injection over 5-hours either QD or BID, depending on anticipated diuretic requirements.
subcutaneous furosemide and sc2wear device: subcutaneous furosemide administered via sc2wear device vs. standard of care
|
Usual Care
n=4 Participants
Subjects randomized to usual care will continue to receive inpatient therapy, eventual transition to oral diuretics, and discharge and post discharge care as per the discretion of the treating clinician and standard treatment guidelines.
|
|---|---|---|
|
Patient Safety Measured by Serious Adverse Events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Data not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 daysPopulation: Data not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 daysPopulation: Data not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 daysPopulation: Data not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 daysPopulation: Data not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Subcutaneous Furosemide and sc2wear Device
n=7 Participants
Subjects will receive device training and study materials (SQ pump device and up to a 7 day supply of SQ furosemide vials) on the day of randomization (study day 0) and discharged within 24 hours. Subjects will be discharged with planned treatment of 80 mg subcutaneous furosemide injection over 5-hours either QD or BID, depending on anticipated diuretic requirements.
subcutaneous furosemide and sc2wear device: subcutaneous furosemide administered via sc2wear device vs. standard of care
|
Usual Care
n=4 Participants
Subjects randomized to usual care will continue to receive inpatient therapy, eventual transition to oral diuretics, and discharge and post discharge care as per the discretion of the treating clinician and standard treatment guidelines.
|
|---|---|---|
|
Death at 30 Days
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 7 daysPopulation: Data not collected.
On a 0-10 scale of breathlessness
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 daysPopulation: Data not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 daysPopulation: Data not collected.
Outcome measures
Outcome data not reported
Adverse Events
Subcutaneous Furosemide and sc2wear Device
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Subcutaneous Furosemide and sc2wear Device
n=7 participants at risk
Subjects will receive device training and study materials (SQ pump device and up to a 7 day supply of SQ furosemide vials) on the day of randomization (study day 0) and discharged within 24 hours. Subjects will be discharged with planned treatment of 80 mg subcutaneous furosemide injection over 5-hours either QD or BID, depending on anticipated diuretic requirements.
subcutaneous furosemide and sc2wear device: subcutaneous furosemide administered via sc2wear device vs. standard of care
|
Usual Care
n=4 participants at risk
Subjects randomized to usual care will continue to receive inpatient therapy, eventual transition to oral diuretics, and discharge and post discharge care as per the discretion of the treating clinician and standard treatment guidelines.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
14.3%
1/7 • Number of events 2 • Time of consent to day 30
|
0.00%
0/4 • Time of consent to day 30
|
|
Investigations
Transferrin Saturation Decreased
|
14.3%
1/7 • Number of events 1 • Time of consent to day 30
|
0.00%
0/4 • Time of consent to day 30
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7 • Time of consent to day 30
|
25.0%
1/4 • Number of events 1 • Time of consent to day 30
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
14.3%
1/7 • Number of events 1 • Time of consent to day 30
|
0.00%
0/4 • Time of consent to day 30
|
Additional Information
Rachel Olson, Project Leader
Duke Clinical Research Institute
Phone: 919-668-5590
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place