Assessment of Coronary Flow Reserve in Heart Failure Patients After Ultrafiltration Versus Diuretics
This study has been terminated.
(Population not available for enrollment)
Information provided by (Responsible Party):
Myron C. Gerson, University of Cincinnati
First received: October 19, 2011
Last updated: October 24, 2016
Last verified: October 2016
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.
Acute Decompensated Heart Failure
Drug: Loop diuretics (furosemide, torsemide, bumetanide)
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
||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
Primary Outcome Measures:
- Myocardial Blood Flow [ Time Frame: 1 - 5 days ] [ Designated as safety issue: No ]
Evaluate the effects of ultrafiltration (UF) compared to intravenous diuretic therapy on myocardial blood flow (MBF) and coronary flow reserve (CFR), as assessed by positron emission tomography (PET), in patients with acutely decompensated heart failure (ADHF).
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2013 (Final data collection date for primary outcome measure)
Active Comparator: Ultrafiltration
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.
Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization or outpatient heart failure clinic for the management of fluid overload. If randomized to the ultrafiltration arm, on admission to the hospital patients will be initiated on ultrafiltration therapy for 2-5 days.
Patients randomized to UF will be treated using the Aquadex System 100 ultrafiltration device (CHF Solutions, Minneapolis, MN). The selection of ultrafiltration rate (fluid removal rate)will be determined by the treating physicians based upon clinical assessment of volume status and perceived safety.
Other Name: Aquadex System 100 ultrafiltration device
Active Comparator: Diuretic Therapy
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.
Drug: Loop diuretics (furosemide, torsemide, bumetanide)
Patients with ADHF and hypervolemia will be enrolled in a prospective, randomized fashion.
Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization for the management of fluid overload.
Patients randomized to diuretic therapy will be treated with intravenous loop diuretics (e.g. furosemide, bumetanide, torsemide). The selection of diuretic, dose and frequency of diuretic administration will be determined by the treating physicians based upon clinical assessment of volume status, response to medication, and perceived safety.
- Lasix, furosemide
- Bumex, bumetanide
- Demadex, torsemide
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.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01457053
|University of Cincinnati/University Hospital
|Cincinnati, Ohio, United States, 45221 |
|Cincinnati, Ohio, United States, 45267 |
University of Cincinnati
||Myron Gerson, MD
||University of Cincinnati
||Myron C. Gerson, MD, University of Cincinnati
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 19, 2011
|Results First Received:
||December 19, 2014
||October 24, 2016
||United States: Institutional Review Board
|Individual Participant Data
|Plan to Share IPD:
Keywords provided by University of Cincinnati:
Acute decompensated heart failure
Myocardial blood flow
Coronary flow reserve
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 08, 2016
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