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| Sponsor: | Intermountain Health Care, Inc. |
|---|---|
| Collaborator: |
Novartis |
| Information provided by: | Intermountain Health Care, Inc. |
| ClinicalTrials.gov Identifier: | NCT00343499 |
Purpose
24 week, single center, prospective, randomized, double-blind treatment study of valsartan (80 mg/bid, increased to 160 mg/bid) or placebo in addition to other general medical therapy in patients with persistent atrial fibrillation (AF) undergoing electrical cardioversion to restore normal sinus rhythm (SR).
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation |
Drug: valsartan |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Single Center, Randomized Trial to Evaluate the Effects of Diovan to Maintain Sinus Rhythm in Patients With Persistent Atrial Fibrillation |
| Estimated Enrollment: | 200 |
| Study Start Date: | November 2004 |
| Study Completion Date: | July 2007 |
To evaluate the efficacy of valsartan, added to standard AF therapy, to maintain sinus rhythm and extend the interval to first AF recurrence after cardioversion.Evaluate the efficacy of valsartan, begun prior to cardioversion, on the difficulty (number and total energy of CV attempts), the net rate of cardioversion (to SR for >10 minutes), and early AF recurrence rate (within 24 hours)
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Utah | |
| McKay Dee Hospital | |
| Ogden, Utah, United States, 84403 | |
| LDS Hospital | |
| Salt Lake City, Utah, United States, 84143 | |
| Dixie Regional Medical Center | |
| St. George, Utah, United States, 84770 | |
| Principal Investigator: | Jeffrey L Anderson, MD | Intermountain Healthcare, LDS Hospital |
More Information
| ClinicalTrials.gov Identifier: | NCT00343499 History of Changes |
| Other Study ID Numbers: | 128-011 |
| Study First Received: | June 21, 2006 |
| Last Updated: | August 20, 2008 |
| Health Authority: | United States: Food and Drug Administration |
|
atrial fibrillation valsartan sinus rhythm persistent atrial fibrillation undergoing electrical cardioversion to restore normal sinus rhythm |
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Valsartan Angiotensin II Type 1 Receptor Blockers |
Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |