Trial Outcomes & Findings for Assessment of Coronary Flow Reserve in Heart Failure Patients After Ultrafiltration Versus Diuretics (NCT NCT01457053)

Results Overview

Evaluate the effects of ultrafiltration (UF) compared to intravenous diuretic therapy on myocardial blood flow (MBF) and coronary flow reserve (CFR), as assessed by positron emission tomography (PET), in patients with acutely decompensated heart failure (ADHF).

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

1 - 5 days

Results posted on

2016-12-05

Participant Flow

Patients with acute decompensated heart failure

Participant milestones

Participant milestones
Measure	Ultrafiltration Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretics. The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy. Ultrafiltration: Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization or outpatient heart failure clinic for the management of fluid overload. If randomized to the ultrafiltration arm, on admission to the hospital patients will be initiated on ultrafiltration therapy for 2-5 days. Patients randomized to UF will be treated using the Aquadex System 100 ultrafiltration device (CHF Solutions, Minneapolis, MN). The selection of ultrafiltration rate (fluid removal rate)will be determined by the treating physicians based upon clinical assessment of volume status and perceived safety.	Diuretic Therapy Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretic therapy. The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy. Loop diuretics (furosemide, torsemide, bumetanide): Patients with ADHF and hypervolemia will be enrolled in a prospective, randomized fashion. Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization for the management of fluid overload. Patients randomized to diuretic therapy will be treated with intravenous loop diuretics (e.g. furosemide, bumetanide, torsemide). The selection of diuretic, dose and frequency of diuretic administration will be determined by the treating physicians based upon clinical assessment of volume status, response to medication, and perceived safety.
Overall Study STARTED	2	2
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Ultrafiltration Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretics. The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy. Ultrafiltration: Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization or outpatient heart failure clinic for the management of fluid overload. If randomized to the ultrafiltration arm, on admission to the hospital patients will be initiated on ultrafiltration therapy for 2-5 days. Patients randomized to UF will be treated using the Aquadex System 100 ultrafiltration device (CHF Solutions, Minneapolis, MN). The selection of ultrafiltration rate (fluid removal rate)will be determined by the treating physicians based upon clinical assessment of volume status and perceived safety.	Diuretic Therapy Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretic therapy. The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy. Loop diuretics (furosemide, torsemide, bumetanide): Patients with ADHF and hypervolemia will be enrolled in a prospective, randomized fashion. Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization for the management of fluid overload. Patients randomized to diuretic therapy will be treated with intravenous loop diuretics (e.g. furosemide, bumetanide, torsemide). The selection of diuretic, dose and frequency of diuretic administration will be determined by the treating physicians based upon clinical assessment of volume status, response to medication, and perceived safety.
Overall Study Unable to undergo selected treatment	1	1

Baseline Characteristics

Assessment of Coronary Flow Reserve in Heart Failure Patients After Ultrafiltration Versus Diuretics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=4 Participants 2 subjects completed the study. 2 subjects did not complete either arm and did not have usable data.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Gender Female	1 Participants n=5 Participants
Gender Male	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 - 5 days

Population: No data analyzed due to inadequate enrollment.

Evaluate the effects of ultrafiltration (UF) compared to intravenous diuretic therapy on myocardial blood flow (MBF) and coronary flow reserve (CFR), as assessed by positron emission tomography (PET), in patients with acutely decompensated heart failure (ADHF).

Outcome measures

Outcome data not reported

Adverse Events

Ultrafiltration

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Diuretic Therapy

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. Myron C. Gerson/Professor of Medicine

University of Cincinnati Medical Center

Phone: 5135583074

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place