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Eplerenone on Cardiac Remodeling in Patients with Left Ventricular Systolic Dysfunction and Mild to Moderate Heart Failure Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Eplerenone on Cardiac Remodeling in Patients with Left Ventricular Systolic Dysfunction and Mild to Moderate Heart Failure conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Eplerenone on Cardiac Remodeling in Patients with Left Ventricular Systolic Dysfunction and Mild to Moderate Heart Failure Clinical research trials and Eplerenone on Cardiac Remodeling in Patients with Left Ventricular Systolic Dysfunction and Mild to Moderate Heart Failure healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Eplerenone on Cardiac Remodeling in Patients with Left Ventricular Systolic Dysfunction and Mild to Moderate Heart Failure. Eplerenone on Cardiac Remodeling in Patients with Left Ventricular Systolic Dysfunction and Mild to Moderate Heart Failure Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Eplerenone on Cardiac Remodeling in Patients with Left Ventricular Systolic Dysfunction and Mild to Moderate Heart Failure clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Eplerenone on Cardiac Remodeling in Patients with Left Ventricular Systolic Dysfunction and Mild to Moderate Heart Failure condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "E" Clinical Trials Conditions > Eplerenone on Cardiac Remodeling in Patients with Left Ventricular Systolic Dysfunction and Mild to Moderate Heart Failure  Eplerenone on Cardiac Remodeling in Patients with Left Ventricular Systolic Dysfunction and Mild to Moderate Heart Failure
Eplerenone on Cardiac Remodeling in Patients with Left Ventricular Systolic Dysfunction and Mild to Moderate Heart Failure
For Condition: Congestive Heart Failure
Status: Not yet recruiting
Sponsor(s): Pfizer ,
Synopsis: The purpose of this study is to determine whether eplerenone slows or prevents further enlargement of the heart. It will also evaluate whether eplerenone improves or stabilizes the heart's pumping ability.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 21 Years/80 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Male or non-pregnant female aged 21 to 80 years - Current symptoms consistent with mild to moderate heart failure (NYHA functional class II and III) - LVEF (left ventricular ejection fraction) of <35% by equilibrium-gated RVG at screening - Therapy with an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) and beta-blocker (BB) (unless documented intolerance) for at least 3 months duration and at dose that has not been adjusted within the previous 4 weeks - The Investigator must obtain written informed consent before the subject is screened for the study Exclusion Criteria: - Current decompensated heart failure or heart failure hospitalization or severe heart failure (NYHA functional class IV) within 6 months of screening - Heart failure due to primary valvular or congenital etiology - Life expectancy less than 9 months or planned cardiac transplantation within 9 months - Unwilling or unable to participate for the 9 month duration of the study - Serum potassium >5.5 mEq/L - History of hyperkalemia (K>6.0 mEq/L) with eplerenone or spironolactone - Creatinine clearance of <30 mL/min based on the Cockcroft-Gault formula - Myocardial infarction or stroke within 3 months of screening - Evidence of clinical instability (hypotension, arrhythmias, unstable angina etc.) - Hypotension (SBP <90 mmHg) - Biventricular pacemaker or implantable cardioverter defibrillator (ICD) placed within 6 months of screening or firing of ICD within 1 month of screening - Prior participation in a cardiac remodeling study - Subjects on or requiring K-sparing diuretics or spironolactone - Use of eplerenone or potassium sparing diuretics including spironolactone, amiloride, or triamterene within 30 days of randomization or for more than 7 days within the previous 6 months - Concomitant use of potent inhibitors of CYP3A4 including ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, and nelfinavir or any drug noted in the Contraindications, Warnings or Precautions sections of their labeling to be potent CYP3A4 inhibitors - Hematocrit <30% - Known hypersensitivity to eplerenone or spironolactone - Evidence of current alcohol or drug abuse - Severe organic disorders or surgery or disease of the gastrointestinal tract that in the opinion of the Investigator may interfere in the absorption and elimination of the study drug - Psychoses or behavioral conditions that in the opinion of the Investigator would limit study compliance - Subjects who have received any investigational medication or used any investigational device within 30 days prior to first dose of study drug or subjects actively participating in any investigational drug or device study
Total Enrollment: 250
Location and Contact Information:
Pfizer Investigational Site
Augusta, Georgia, 30901
United States
Additional Information:
Study ID Numbers: A6141078;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00082589
Other Congestive Heart Failure Studies:
1. DITPA, A Thyroid Hormone Analog to Treat Heart Failure
2. Autologous Cultured Myoblasts (BioWhittaker) Transplanted via Myocardial Injection
3. Trial of a Tailored Message Program to Implement CHF Guidelines
4. African-American Heart Failure Trial
5. Multicenter, Randomized, Double-Blind, Placebo Controlled, Efficacy Study on the Effects of Tolvaptan on Left Ventricular Dilatation in Congestive Heart Failure Patients
Related Studies:
Other Congestive Heart Failure Clinical Trials
Other Georgia Clinical Trials
Other Augusta Clinical Trials
Eplerenone on Cardiac Remodeling in Patients with Left Ventricular Systolic Dysfunction and Mild to Moderate Heart Failure
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