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