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

University of Cincinnati

Status: Terminated

Conditions: Acute Decompensated Heart Failure

Treatments: Drug: Loop diuretics (furosemide, torsemide, bumetanide); Other: Ultrafiltration

Study type: Interventional

Funder types: Other

Identifiers

NCT01457053

11051904

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

4 participants in 2 patient groups

Ultrafiltration

Active Comparator group

Description:

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.

Treatment:

Other: Ultrafiltration

Diuretic Therapy

Active Comparator group

Description:

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.

Treatment:

Drug: Loop diuretics (furosemide, torsemide, bumetanide)