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Evaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure. | Clinical Trials | Clareo Health

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Evaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure.

Randomized, Multicenter Evaluation of Intravenous Levosimendan Efficacy Versus Placebo in the Short Term Treatment of Decompensated Chronic Heart Failure: the REVIVE II Study.

NCT00048425•Abbott

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy of a 24-hour infusion of levosimendan compared with placebo in the treatment of decompensated chronic heart failure.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•A written informed consent must be obtained for hospitalized male or female patients over 18 years old of age.
•The eligible patients must be diagnosed with worsening heart failure as evidenced by dyspnea at rest, poor ejection fraction and have been treated with IV diuretics.
•It is allowable for the patients to be treated with IV inotropes and vasodilators.

Exclusion Criteria

•The following criteria would exclude the patient from study:
•invasive cardiac procedure (e.g. cardiac surgery, LVAD, cardioversion, cardiac re-synchronization),
•rhythm disorders (e.g. earlier Torsades de Pointes, increased heart rate),
•severe ventricular outflow obstruction,
•angina,
•hypotension,
•uncorrected hypokalemia,
•CNS (e.g. stroke, TIA),
•respiratory (e.g. COPD, intubated patients, oral,
•intravenous or intramuscular steroids),
+5 more criteria

Locations (166)

Cardiovascular Associates/Office of Clinical Research

Birmingham, Alabama, United States

Cardiology, P.C. Research

Birmingham, Alabama, United States

University Alabama at Birmingham

Birmingham, Alabama, United States

Oracle Research-The Heart Center

Huntsville, Alabama, United States

Providence Hospital Heart Failure Clinic

Mobile, Alabama, United States

Arizona Heart Institute

Phoenix, Arizona, United States

Sarver Heart Center - University of Arizona Health Science

Tucson, Arizona, United States

Central Arkansas Veterans Healthcare System

Little Rock, Arkansas, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Central Cardiology Medical Center

Bakersfield, California, United States

Key Dates

Start Date

September 1, 2002

Completion Date

December 1, 2004

Last Updated

December 15, 2006

Enrollment

600

Estimated participants

Conditions

Heart Failure, Congestive

Interventions

Levosimendan

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 15, 2006Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Evaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure.

Inclusion Criteria

Exclusion Criteria

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