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

This study has been terminated.
(Population not available for enrollment)
Sponsor:
Information provided by (Responsible Party):
Myron C. Gerson, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01457053
First received: October 19, 2011
Last updated: October 24, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention
Acute Decompensated Heart Failure
Drug: Loop diuretics (furosemide, torsemide, bumetanide)
Other: Ultrafiltration

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

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).


Enrollment: 4
Study Start Date: November 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: 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.

Other Names:
  • Lasix, furosemide
  • Bumex, bumetanide
  • Demadex, torsemide

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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

Locations
United States, Ohio
University of Cincinnati/University Hospital
Cincinnati, Ohio, United States, 45221
University Hospital
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Myron Gerson, MD University of Cincinnati
  More Information

Responsible Party: Myron C. Gerson, MD, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01457053     History of Changes
Other Study ID Numbers: 11051904 
Study First Received: October 19, 2011
Results First Received: December 19, 2014
Last Updated: October 24, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Cincinnati:
Acute decompensated heart failure
Myocardial blood flow
Coronary flow reserve
Ultrafiltration
Diuretics

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Torsemide
Bumetanide
Furosemide
Diuretics
Sodium Potassium Chloride Symporter Inhibitors
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 08, 2016