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ESSENTIAL-"The Studies of Oral Enoximone Therapy in Advanced Heart Failure" Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about ESSENTIAL-"The Studies of Oral Enoximone Therapy in Advanced Heart Failure" conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. ESSENTIAL-"The Studies of Oral Enoximone Therapy in Advanced Heart Failure" Clinical research trials and ESSENTIAL-"The Studies of Oral Enoximone Therapy in Advanced Heart Failure" health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like ESSENTIAL-"The Studies of Oral Enoximone Therapy in Advanced Heart Failure". ESSENTIAL-"The Studies of Oral Enoximone Therapy in Advanced Heart Failure" Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a ESSENTIAL-"The Studies of Oral Enoximone Therapy in Advanced Heart Failure" clinical trial. Human subjects often get the best healthcare available for their ESSENTIAL-"The Studies of Oral Enoximone Therapy in Advanced Heart Failure" condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "E" Clinical Trials Conditions > ESSENTIAL-"The Studies of Oral Enoximone Therapy in Advanced Heart Failure"  ESSENTIAL-"The Studies of Oral Enoximone Therapy in Advanced Heart Failure"
ESSENTIAL-"The Studies of Oral Enoximone Therapy in Advanced Heart Failure"
For Condition: Heart Failure, Congestive
Status: Recruiting
Sponsor(s): Myogen ,
Synopsis: To determine if low-dose enoximone therapy is an effective treatment for advanced chronic heart failure.
Details: The study is a randomized, double-blind, multicenter, parallel group, placebo-controlled trial of oral enoximone in approximately 700 subjects with advanced chronic heart failure of either ischemic or nonischemic etiology receiving optimal conventional heart failure therapy. Eligible subjects will be randomized in a 1:1 ratio to receive either enoximone or placebo at the Randomization Visit. The initial dose of study drug will be 25 mg t.i.d.(3xday) and will be administered immediately after randomization. Subjects who tolerate this initial dose will be continued on 25 mg t.i.d. for at least two weeks. After two weeks, eligible subjects will be titrated to 50 mg t.i.d. for the duration of the study.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: In order to be considered eligible subjects, the following entry criteria must be met: - At least 18 years of age - ischemic or nonischemic cardiomyopathy - NYHA Class III or IV - symptoms of dyspnea and/or fatigue at rest or on minimal exertion for at least 2 months - one hospitalization, or two outpatient visits, for the treatment of worsening heart failure within 12 months requiring the administration of I.V. heart failure therapy - LVEDD >3.2 cm/m2 or >=6.0 cm - LVEF of less than or equal to 30% - concomitant treatment with optimal conventional heart failure therapy Exclusion Criteria Subjects who meet any one of the following criteria will be deemed ineligible for participation in the study: - heart failure due to uncorrected primary valvular disease, uncorrected thyroid disease, obstructive/hypertrophic cardiomyopathy, pericardial disease, amyloidosis, active myocarditis, malfunctioning artificial heart valve, uncorrected congenital heart disease, isolated right-sided heart failure, or primary pulmonary hypertension - undergone a cardiac revascularization, valvular surgery, or bi-ventricular resynchronization procedure within 60 days - myocardial infarction within 90 days - ECG at screening with evidence of transmural ischemia (dynamic ST elevation or ST elevation associated with ischemic symptoms), ventricular tachycardia (VT) or premature ventricular complexes (PVCs) associated with symptoms, or VT of >6 beats - sustained (>15 seconds) VT - AICD that has fired for any ventricular arrhythmia within 90 days prior to the Randomization Visit - documented diagnosis of angina that is unstable at any time within the 60 days prior to Screening or is the primary symptom that limits daily activity - ventricular reduction surgery or cardiac myoplasty - Subjects on a mechanical assist device Subjects on the following concomitant medications: - Calcium antagonists other than amlodipine or felodipine - Flecainide, encainide, propafenone, dofetilide or disopyramide - Subjects receiving I.V. positive inotropic agents within seven days of the Screening Visit or Randomization Visit - Subjects receiving a human B-type natriuretic peptide, including nesiritide, within seven days of the Screening Visit or Randomization Visit - Subjects receiving oral or I.V. phosphodiesterase III inhibitors (PDEI III), including levosimendan and cilostazol, within seven days of the Screening Visit or Randomization Visit - Subjects with active hepatic (screening serum total bilirubin >= 3.0 mg/dl (>=51.3 umol/l), renal (screening serum creatinine >= 2.0 mg/dl (=178.8 umol/l)), hematologic, gastrointestinal, immunologic, endocrine, metabolic, or central nervous system disease - Subjects with a serum potassium <4.0 mEq/L or >5.5 mEq/L (<4.0 mmol/l or >5.5 mmol/l) at Randomization Visit - Subjects with a magnesium level of <1.0 mEq/L (<0.5 mmol/l) at Randomization Visit (Visit 0) - Subjects with a serum digoxin of >1.2 ng/ml (>1.5 nmol/l) or a serum digitoxin of >20 ng/ml (>26.2 nmol/l) at the Randomization Visit are excluded. A target serum digoxin level of <=1.0 ng/ml (<=1.3 nmol/l) is recommended
Total Enrollment: 1400
Location and Contact Information:
Johns Hopkins Medical Institutions *Recruiting*
Baltimore, Maryland, 21287
United States
Recruiting Stacey Nash 410-502-7310
CAVHS *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting Sharon Shuler 501-257-5842
Cardiopulmonary Research Science and Technology Institute *Recruiting*
Dallas, Texas, 75230
United States
Recruiting Natasha Magee 972-566-6389
Beth Israel Medical Center *Recruiting*
New York City, New York, 10003
United States
Recruiting Jill Kalman 212-844-8823
University of Utah Health Sciences Center *Recruiting*
Salt Lake City, Utah, 84111
United States
Recruiting Abigail Ensign 801-585-5122
Aurora Denver Cardiology Associates *Recruiting*
Denver, Colorado, 80218
United States
Recruiting Melinda Washam 303-839-7789
Clinical Research of West Florida, Inc. *Recruiting*
Tampa, Florida, 33607
United States
Recruiting Marla Davis 813-870-1292
The Care Group *Recruiting*
Indianapolis, Indiana, 46260
United States
Recruiting Judy Mullennax 317-338-6152
Ohio State University *Recruiting*
Columbus, Ohio,
United States
Recruiting Phillip Binkley
Access Clinical Trials *Recruiting*
Beverly Hills, California, 90210
United States
Recruiting Jose Garcia 310-275-9551
University of Wisconsin Medical School *Recruiting*
Madison, Wisconsin, 53715
United States
Recruiting Lori Wollet 608-287-2856
University of Florida Health Science Center of Jacksonville *Recruiting*
Jacksonville, Florida, 32209
United States
Recruiting Frank Lund 904-244-2682
Kaiser Santa Teresa *Recruiting*
San Jose, California, 95119
United States
Recruiting Dana Weisshaar 408-972-6428
Jack D. Weiler Hospital of The Albert Einstein *Recruiting*
New York City, New York, 10461
United States
Recruiting Norma Cesari 718-904-2193
Western Pennsylvania Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15224
United States
Recruiting Barbara Thompson 412-578-1408
Oregon Health and Science University *Recruiting*
Portland, Oregon,
United States
Recruiting Diana Dutton 503-494-3958
New York Presbyterian Hospital *Recruiting*
New York City, New York, 10032
United States
Recruiting Deborah Ascheim 212-305-9264
Bryan LGH Heart Institute *Recruiting*
Lincoln, Nebraska, 68516
United States
Recruiting Steve Krueger 402-483-3371
Heart and Vascular Clinic of Northern Colorado *Recruiting*
Fort Collins, Colorado, 80528
United States
Recruiting Liz Ortolano 970-297-6812
University of Pennslyvania *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting David Wolfe 215-662-4214
Victoria Heart Institute Foundation *Recruiting*
Victoria, British Columbia,
Canada
Recruiting W. Klinke (250)595-1884
LAC-USC Medical Center *Recruiting*
Los Angeles, California, 90033
United States
Recruiting Salman Khan 323-276-7541
Durham VA Medical Center *Recruiting*
Durham, North Carolina, 27701
United States
Recruiting Fred Cobb 919-286-0441
Cardiac Solutions *Recruiting*
Peoria, Arizona, 85381
United States
Recruiting Sanja Obradov 623-876-8816
Florida Cardiovascular Research *Recruiting*
Atlantis, Florida, 33462
United States
Recruiting Jamie Kosik 561-548-5538
Sacramento Heart and Vascular Research *Recruiting*
Sacramento, California, 95825
United States
Recruiting Janine Carlson 916-830-2020
Blackstone Cardiology *Recruiting*
Pawtucket, Rhode Island,
United States
Recruiting Catherine Alteri 401-723-1210
Wisconsin Center for Clinical Research *Recruiting*
Elkhorn, Wisconsin, 53121
United States
Recruiting JoAnn Kiemen 262-723-8882
Loma Linda University Medical Center *Recruiting*
Loma Linda, California, 92357
United States
Recruiting Sharon Fabbri 909-558-4000
Cardiology Research Associates *Recruiting*
Ormond Beach, Florida, 32174
United States
Recruiting Dona Baker 386-677-6672
Montreal Heart Institute *Recruiting*
Montreal, Quebec,
Canada
Recruiting Michel White (514) 376-3330
Androscoggin Cardiology Associates *Recruiting*
Auburn, Maine, 04210
United States
Recruiting Diane Cass 207-782-9835
Emory University Hospital *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting Gail Snell 414-712-0531
Additional Information:
Study ID Numbers: ESSENTIAL: My-021 and My-026;
Study Start Date: February 2002
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00051285
Other Heart Failure, Congestive Studies:
1. Occluded Artery Trial (OAT)
2. Prevalence of Asymptomatic Ventricular Dysfunction
3. Effect of Behavioral Management on Quality of Life in Heart Failure
4. Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE)
5. Beta-Blocker Evaluation in Survival Trial (BEST)
Related Studies:
Other Heart Failure, Congestive Clinical Trials
Other Utah Clinical Trials
Other Salt Lake City Clinical Trials
ESSENTIAL-"The Studies of Oral Enoximone Therapy in Advanced Heart Failure"
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