Trial Outcomes & Findings for Clinical Utility of Subcutaneous Furosemide in Patients Presenting With Early Signs of Fluid Overload (NCT NCT03359161)

NCT ID: NCT03359161

Last Updated: 2022-10-13

Results Overview

Weight change between enrollment/screening compared to last observation

• Recruitment status: TERMINATED
• Study phase: PHASE2/PHASE3
• Target enrollment: 9 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2022-10-13

Participant Flow

Participant milestones

Measure	In-Home Subcutaneous Furosemide Treatment ARm Prospective, open-label arm to evaluate the clinical effectiveness of a novel formulation of furosemide delivered by subcutaneous administration. sc2Wear Furosemide Infusor: Subcutaneous furosemide for the treatment of fluid overload
Overall Study STARTED	9
Overall Study Pilot Phase	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Utility of Subcutaneous Furosemide in Patients Presenting With Early Signs of Fluid Overload

Baseline characteristics by cohort

Measure	In-Home Subcutaneous Furosemide Treatment ARm n=9 Participants Prospective, open-label arm to evaluate the clinical effectiveness of a novel formulation of furosemide delivered by subcutaneous administration. sc2Wear Furosemide Infusor: Subcutaneous furosemide for the treatment of fluid overload
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Weight change between enrollment/screening compared to last observation

Outcome measures

Measure	In-Home Subcutaneous Furosemide Treatment ARm n=9 Participants Prospective, open-label arm to evaluate the clinical effectiveness of a novel formulation of furosemide delivered by subcutaneous administration. sc2Wear Furosemide Infusor: Subcutaneous furosemide for the treatment of fluid overload
Weight Change	-3 pounds Interval -7.0 to 6.5

PRIMARY outcome

Timeframe: 30 days

Reduction in pro-BNP between enrollment/screening compared to last observation

Outcome measures

Measure	In-Home Subcutaneous Furosemide Treatment ARm n=9 Participants Prospective, open-label arm to evaluate the clinical effectiveness of a novel formulation of furosemide delivered by subcutaneous administration. sc2Wear Furosemide Infusor: Subcutaneous furosemide for the treatment of fluid overload
Pro BNP Change	412.9 pg/ml Standard Deviation 0

PRIMARY outcome

Timeframe: 30 days

% of patients alive 30 days post enrollment

Outcome measures

Measure	In-Home Subcutaneous Furosemide Treatment ARm n=9 Participants Prospective, open-label arm to evaluate the clinical effectiveness of a novel formulation of furosemide delivered by subcutaneous administration. sc2Wear Furosemide Infusor: Subcutaneous furosemide for the treatment of fluid overload
Survival	100 percentage of participants

PRIMARY outcome

Timeframe: 30 days

% of patients without hospitalization for worsening HF within 30 days after enrollment

Outcome measures

Measure	In-Home Subcutaneous Furosemide Treatment ARm n=9 Participants Prospective, open-label arm to evaluate the clinical effectiveness of a novel formulation of furosemide delivered by subcutaneous administration. sc2Wear Furosemide Infusor: Subcutaneous furosemide for the treatment of fluid overload
Hospital Admission for Heart Failure	89 percentage of participants

PRIMARY outcome

Timeframe: 30 days

% of patients without a significant Heart Failure related medical events within 30 days after enrollment.

Outcome measures

Measure	In-Home Subcutaneous Furosemide Treatment ARm n=9 Participants Prospective, open-label arm to evaluate the clinical effectiveness of a novel formulation of furosemide delivered by subcutaneous administration. sc2Wear Furosemide Infusor: Subcutaneous furosemide for the treatment of fluid overload
Heart Failure Related Events	100 percentage of participants

PRIMARY outcome

Timeframe: 7 days

Percentage of patients requiring additional 4 days of diuresis

Outcome measures

Measure	In-Home Subcutaneous Furosemide Treatment ARm n=9 Participants Prospective, open-label arm to evaluate the clinical effectiveness of a novel formulation of furosemide delivered by subcutaneous administration. sc2Wear Furosemide Infusor: Subcutaneous furosemide for the treatment of fluid overload
Extra Furosemide Treatment	6 Participants

PRIMARY outcome

Timeframe: 7 days

The number of participants that discontinued study participation due to the presence of a skin reaction to the drug or device/adhesive.

Outcome measures

Measure	In-Home Subcutaneous Furosemide Treatment ARm n=9 Participants Prospective, open-label arm to evaluate the clinical effectiveness of a novel formulation of furosemide delivered by subcutaneous administration. sc2Wear Furosemide Infusor: Subcutaneous furosemide for the treatment of fluid overload
Number of Participants That Discontinued Due to Presence of Skin Reaction to Drug or Device/Adhesive	0 Participants

Adverse Events

In-Home Subcutaneous Furosemide Treatment ARm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lana Tsao

St. Elizabeth's Medical Center

Phone: 617-789-3036

Email: lana.tsao@steward.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place