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Sponsors and Collaborators: |
Gilead Sciences AstraZeneca |
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Information provided by: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT00077948 |
Beta-blocker medications have been shown to improve heart function and prolong the lives of patients with chronic heart failure (CHF). Some people with advanced CHF have difficulty taking beta-blocker medications due to troublesome side effects, such as low blood pressure and/or low heart rate, severe tiredness, dizziness, or shortness of breath. In other words, they have difficulty tolerating beta-blocker medications. The purpose of this study is to determine if enoximone can improve a patient's ability to tolerate a beta-blocker medication.
Condition | Intervention | Phase |
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Heart Failure, Congestive |
Drug: enoximone plus metoprolol succinate Drug: metoprolol succinate alone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Randomized, Double-Blind, Double Placebo-Controlled, Multicenter, Three Parallel Group Study of Enoximone Plus Extended-Release Metoprolol Succinate in Advanced CHF Subjects Previously Intolerant to Beta-Blocker Treatment |
Estimated Enrollment: | 175 |
Study Start Date: | July 2003 |
Over the last decade, it has become evident that certain beta-blocking agents (beta-blockers) exert a favorable effect on the natural history of mild to moderate chronic heart failure (CHF), including reducing mortality and hospitalization rate. However, as heart failure becomes more severe, beta-blockers become difficult to administer because of myocardial depression leading to hemodynamic intolerance. A recent clinical study demonstrated that subjects who could not tolerate the beta-blocker metoprolol experienced improved tolerability when low-dose, oral enoximone was administered prior to the introduction of metoprolol and during ongoing treatment. This study will investigate the hypotheses that by stabilizing subjects on enoximone first, advanced CHF subjects who are intolerant of beta-blockade will be able to 1) tolerate the effects of beta-blocker therapy, and 2) have clinical benefit that is due to the combination of both enoximone and extended-release metoprolol succinate (ER metoprolol). Support for these hypotheses will be sought by demonstrating that, as compared to placebo, low-dose, oral enoximone plus ER metoprolol will increase left ventricular ejection fraction (LVEF), improve symptoms of heart failure, and improve submaximal exercise tolerance in subjects with CHF.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria
In order to be considered an eligible subject, all of the following entry criteria must be met:
LVEF must be assessed by radionuclide ventriculography (MUGA). If the subject has experienced any cardiovascular events, has undergone any interventions, or received any changes in treatment that may have affected LV function since the most recent EF measurement, an LVEF measurement must be completed prior to the subject being randomized.
Exclusion criteria
Subjects who meet any one of the following criteria will be deemed ineligible for participation in the study:
type-III PDE inhibitors within seven days of the Screening Visit or Randomization Visit.
United States, Colorado | |
University of Colorado | |
Denver, Colorado, United States, 80262 | |
United States, Utah | |
University of Utah | |
Salt Lake City, Utah, United States, 84132 |
Study ID Numbers: | EMPOWER (Protocol My-023) |
Study First Received: | February 13, 2004 |
Last Updated: | January 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00077948 History of Changes |
Health Authority: | United States: Food and Drug Administration |
positive inotrope enoximone beta-blocker intolerant |
Vasodilator Agents Heart Failure Neurotransmitter Agents Heart Diseases Adrenergic Agents Cardiovascular Agents Metoprolol Antihypertensive Agents |
Phosphodiesterase Inhibitors Enoximone Metoprolol succinate Adrenergic beta-Antagonists Adrenergic Antagonists Anti-Arrhythmia Agents Peripheral Nervous System Agents |
Neurotransmitter Agents Vasodilator Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Cardiotonic Agents Physiological Effects of Drugs Therapeutic Uses Adrenergic beta-Antagonists Cardiovascular Diseases Anti-Arrhythmia Agents Heart Failure Sympatholytics Heart Diseases |
Enzyme Inhibitors Cardiovascular Agents Metoprolol Antihypertensive Agents Protective Agents Pharmacologic Actions Phosphodiesterase Inhibitors Enoximone Autonomic Agents Metoprolol succinate Adrenergic Antagonists Peripheral Nervous System Agents |