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

Information source: University of Cincinnati
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Decompensated Heart Failure

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

Phase: N/A

Status: Terminated

Sponsored by: University of Cincinnati

Official(s) and/or principal investigator(s):
Myron Gerson, MD, Principal Investigator, Affiliation: University of Cincinnati


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.

Clinical Details

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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Primary outcome: Myocardial 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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.

Locations and Contacts

University Hospital, Cincinnati, Ohio 45267, United States

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

Additional Information

Starting date: November 2011
Last updated: May 28, 2015

Page last updated: August 23, 2015

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