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

NCT ID: NCT01457053

Last Updated: 2016-12-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-05-31

Brief Summary

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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

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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.

Conditions

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Acute Decompensated Heart Failure

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Ultrafiltration

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Loop diuretics (furosemide, torsemide, bumetanide)

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type OTHER

Other Intervention Names

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Lasix, furosemide Bumex, bumetanide Demadex, torsemide Aquadex System 100 ultrafiltration device

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Myron C. Gerson

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Myron Gerson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

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University of Cincinnati/University Hospital

Cincinnati, Ohio, United States

Site Status

University Hospital

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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11051904

Identifier Type: -

Identifier Source: org_study_id