Heart Failure Clinical Trial

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

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.

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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.

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Eligibility Criteria

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 is for people with:

Heart Failure

Estimated Enrollment:

4

Study ID:

NCT01457053

Recruitment Status:

Terminated

Sponsor:

University of Cincinnati

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There are 2 Locations for this study

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University of Cincinnati/University Hospital
Cincinnati Ohio, 45221, United States
University Hospital
Cincinnati Ohio, 45267, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

4

Study ID:

NCT01457053

Recruitment Status:

Terminated

Sponsor:


University of Cincinnati

How clear is this clinincal trial information?

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