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

Not Applicable

Terminated

• Conditions: Acute Decompensated Heart Failure
• Interventions: Drug: Loop diuretics (furosemide, torsemide, bumetanide); Other: Ultrafiltration

• Registration Number: NCT01457053
• Lead Sponsor: University of Cincinnati

Brief Summary

The purpose of this research study is to compare the effects (good and bad) of ultrafiltration treatment with standard intravenous (in your vein) diuretic therapy (furosemide, torsemide, bumetanide) on your heart function and blood flow.

Detailed Description

The standard of care to treat congestive heart failure is with a class of medication called diuretics, which remove the extra fluid from the body through urination. Another way to remove extra fluid in patients with heart failure is called ultrafiltration. Ultrafiltration may result in more rapid removal of excess fluid and more rapid improvement in your symptoms compared to standard diuretic treatment. Currently, it is unknown what effects these therapies (diuretics or ultrafiltration) have on the small blood vessels in your heart. These small blood vessels are important to supply blood and oxygen to your failing heart. Thus, the purpose of this research study is to compare the effects (good and bad) of ultrafiltration treatment with standard intravenous (in your vein) diuretic therapy on your heart function and blood flow.

Study Timeline

• Study First Submitted: 2011-10-19
• Study First Submitted QC: 2011-10-20
• Study First Posted: 2011-10-21
• Study Start: 2011-11
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Results First Submitted: 2014-12-19
• Results First Submitted QC: 2015-05-28
• Results First Posted: 2015-06-08
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-12-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• males and non-pregnant female patients over 18 years admitted to the hospital or treated in an outpatient heart failure clinic with the primary diagnosis of acute decompensated heart failure.
• evidence of fluid overload more than 8 kg above their dry weight, and conforming to definition of hypervolemia (at least two of the following findings: more than 1+ pitting edema of the lower extremities, jugular venous pressure more than 10 cm water, pulmonary edema or pleural effusion on chest radiograph consistent with ADHF, ascites, paroxysmal nocturnal dyspnea, or equal or more than 2 pillow orthopnea.

Exclusion Criteria

• acute coronary syndrome
• documented ischemic cardiomyopathy
• atrial fibrillation
• serum creatinine more than 3.0 mg/dL
• systolic blood pressure less than 90 mmHg
• hematocrit > 45%
• clinical instability likely to require intravenous vasopressors and/or intravenous vasoactive drugs (such as milrinone, dobutamine, nitroglycerin or nesiritide) during the present hospitalization
• severe pulmonary hypertension or use of pulmonary hypertension drugs (such as sildenafil, bosentan or other endothelin inhibitors)
• patients with documented hypertrophic obstructive cardiomyopathy or restrictive cardiomyopathy,
• patients with severe valvular heart disease,
• patients with recent cocaine use (within one month of presentation)
• patients with heart transplant
• patients with systemic infection
• patients on hemodialysis
• inability to obtain venous access
• contraindications for anticoagulation
• unable to lie flat for at least 20 minutes
• pregnant and breast-feeding women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diuretic Therapy	Loop diuretics (furosemide, torsemide, bumetanide)	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.
Ultrafiltration	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.

Primary Outcome Measures

Name	Time	Method
Myocardial Blood Flow	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).

Trial Locations

Locations (2)

University of Cincinnati/University Hospital; 🇺🇸 Cincinnati, Ohio, United States

University Hospital; 🇺🇸 Cincinnati, Ohio, United States