Assessment of Coronary Flow Reserve in Heart Failure Patients After Ultrafiltration Versus Diuretics
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|ClinicalTrials.gov Identifier: NCT01457053|
Recruitment Status : Terminated (Population not available for enrollment)
First Posted : October 21, 2011
Results First Posted : June 8, 2015
Last Update Posted : December 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Acute Decompensated Heart Failure||Drug: Loop diuretics (furosemide, torsemide, bumetanide) Other: Ultrafiltration||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized Controlled Pilot Study for Assessment of Coronary Flow Reserve With Cardiac PET Imaging in Acute Decompensated Heart Failure Patients Treated With Diuretics Versus Ultrafiltration|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
Active Comparator: Ultrafiltration
Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretics (loop diuretics: furosemide, bumetanide, and/or torsemide). Patients in this arm are randomized to 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.
Other Name: Aquadex System 100 ultrafiltration device
Active Comparator: Diuretic Therapy
Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretic therapy ((loop diuretics: furosemide, bumetanide, and/or torsemide). The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy with either furosemide, bumetanide, and/or torsemide.
Drug: 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.
- Myocardial Blood Flow [ Time Frame: 1 - 5 days ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01457053
|United States, Ohio|
|University of Cincinnati/University Hospital|
|Cincinnati, Ohio, United States, 45221|
|Cincinnati, Ohio, United States, 45267|
|Principal Investigator:||Myron Gerson, MD||University of Cincinnati|