Clinical trial NCT01457053: Assessment of Coronary Flow Reserve in Heart Failure Patients After Ultrafiltration Versus Diuretics
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Decompensated Heart Failure
Keywords: Acute decompensated heart failure
Myocardial blood flow
Coronary flow reserve
Ultrafiltration
Diuretics
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2011-10-21
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Myocardial Blood Flow
timeFrame: 1 - 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati/University Hospital
state: Ohio
city: Cincinnati
country: United States
facility: University Hospital
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Myron Gerson, MD
role: PRINCIPAL_INVESTIGATOR
References: