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| Sponsored by: |
Hebei Medical University |
|---|---|
| Information provided by: | Hebei Medical University |
| ClinicalTrials.gov Identifier: | NCT00125437 |
Purpose
The purpose of this study is to determine whether a larger dose of the aldosterone antagonist spironolactone combined with a lower dose of an ACE inhibitor is more effective in reverse left ventricular remodeling in severe congestive heart failure in patients with nonischemic cardiomyopathy.
| Condition | Intervention |
|---|---|
|
Heart Failure, Congestive |
Drug: spironolactone |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Safety and Efficacy of Larger Dose of Spironolactone for the Treatment of Patients With Nonischemic Cardiomyopathy |
| Estimated Enrollment: | 200 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | September 2009 |
In the investigators' recent daily clinical practice, they found that the larger dose of the aldosterone antagonist spironolactone combined with a lower dose of an ACE inhibitor and the highest tolerable dose of beta blockers could reverse left ventricular remodeling more effectively than a smaller dose of spironolactone. The ventricular remodeling could get back to normal, especially in patients with none-ischaemic cardiomyopathy. The investigators hypothesize that long term use of a larger dose of the aldosterone antagonist spironolactone could reverse left ventricular remodeling by stimulating new myocyte formation. Thus, they designed this study to verify its efficacy and safety in reversing left ventricular remodeling in severe congestive heart failure in patients with nonischemic cardiomyopathy. To avoid hyperkalemia, the investigators routinely use larger doses of diuretics in combination with a lower dose of an ACE inhibitor to offset the potassium-sparing effects of spironolactone and follow the patients closely.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| China, Hebei | |
| The First Hospital of Hebei Medical University | |
| Shijiazhuang, Hebei, China, 050031 | |
| Principal Investigator: | Kunshen Liu, M.D. | The First Hospital of Hebei Medical University |
More Information
| Study ID Numbers: | 05276101D-84 |
| Study First Received: | July 29, 2005 |
| Last Updated: | December 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00125437 History of Changes |
| Health Authority: | China: State Food and Drug Administration |
|
aldosterone antagonists spironolactone left ventricular remodeling |
|
Heart Failure Heart Diseases Aldosterone Antagonists Hormone Antagonists Diuretics |
Hormones, Hormone Substitutes, and Hormone Antagonists Cardiovascular Agents Hormones Cardiomyopathies Spironolactone |
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Heart Failure Heart Diseases Hormone Antagonists Diuretics Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Cardiovascular Agents |
Cardiomyopathies Pharmacologic Actions Spironolactone Aldosterone Antagonists Natriuretic Agents Therapeutic Uses Cardiovascular Diseases |