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

NCT01457053 | Terminated Results DMC

• 1 other identifier: 11051904
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Decompensated Heart Failure

Keywords

Acute decompensated heart failure; Myocardial blood flow; Coronary flow reserve; Ultrafiltration; Diuretics

Outcome Measures

Primary Outcomes (1)

• Myocardial Blood Flow

  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).

  1 - 5 days

Study Arms (2)

Ultrafiltration

ACTIVE COMPARATOR

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

Diuretic Therapy

ACTIVE COMPARATOR

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)

Interventions

Loop diuretics (furosemide, torsemide, bumetanide) DRUG

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.

Also known as: Lasix, furosemide, Bumex, bumetanide, Demadex, torsemide

Diuretic Therapy

Ultrafiltration OTHER

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.

Also known as: Aquadex System 100 ultrafiltration device

Ultrafiltration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (2)

University of Cincinnati/University Hospital

Cincinnati, Ohio, 45221, United States

Location

University Hospital

Cincinnati, Ohio, 45267, United States

Location

MeSH Terms

Interventions

Sodium Potassium Chloride Symporter Inhibitors; Furosemide; Torsemide; Bumetanide; Ultrafiltration

Intervention Hierarchy (Ancestors)

Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Diuretics; Natriuretic Agents; Physiological Effects of Drugs; Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Extracorporeal Circulation; Surgical Procedures, Operative; Filtration; Chemistry Techniques, Analytical; Investigative Techniques; Physical Phenomena; Chemical Phenomena

Results Point of Contact

• Title: Dr. Myron C. Gerson/Professor of Medicine
• Organization: University of Cincinnati Medical Center

myron.gerson@uc.edu

5135583074

Study Officials

• Myron Gerson, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 19, 2011
• First Posted: October 21, 2011
• Study Start: November 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: December 5, 2016
• Results First Posted: June 8, 2015

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)