NCT00343499TerminatedPhase 4
A Single Center, Randomized Trial to Evaluate the Effects of Diovan to Maintain Sinus Rhythm in Patients With Persistent Atrial Fibrillation
Intermountain Health Care, Inc.3 sites in 1 country200 target enrollmentStarted: November 1, 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Enrollment
- 200
- Locations
- 3
- Primary Endpoint
- Time to first AF recurrence on valsartan vs. placebo (time-to-event analysis, log-rank test)
Study Overview
Brief Summary
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).
Detailed Description
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The patient (male or non-pregnant female) must be >18 years of age
- •Have ECG documented AF at the time of enrollment into the study
- •Require (be scheduled for) electrical cardioversion
- •Female patients of childbearing potential must have a documented negative pregnancy test during the index hospitalization.
- •The patient or legally authorized representative willing to give written informed consent, prior to the procedure, using the ICF approved by the UCR Institutional Review Board. Surrogate consent must be given per CV Research SOP.
- •Have a serum potassium level between 3.5 and 5.5 meq/L
- •If diabetic, have a hemoglobin A1C level <11%
- •NYHA I-II can be enrolled if no hospitalizations for heart failure within 6 months or current, known EF<40%.
Exclusion Criteria
- •The patient is unable or unwilling to cooperate with the study follow-up procedures.
- •Pregnant and/or lactating women, and women of child bearing potential not using acceptable means of contraception. Women of childbearing potential must be using adequate measures of contraception (as determined by the Investigator) to avoid pregnancy and should be highly unlikely to conceive during the study period. Women of childbearing potential must have a negative pregnancy test at screen.
- •Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study.
- •Current diagnosis of angina pectoris (no events within a period of 3 months prior to Visit 1 (V1)
- •History or current diagnosis of symptomatic heart failure (NYHA classes III-IV) or
- •documented ejection fraction of < 40 %. Myocardial Infarction within 3 months; coronary revascularization (PCI or CABG), unstable angina within 1 month of V
- •Stroke, deep vein thrombosis (DVT), pulmonary embolism (PE) or transient ischemic attack (TIA) within 3 months of V
- •Substance or alcohol abuse within 6 months of V1
- •Known allergy to any of the drugs administered in the study (angiotensin receptor blocker (ARB) or an angiotensin converting enzyme inhibitor (ACE-I), Valsartan, amiodarone, flecainide or propafenone)
- •Any other contraindication listed in the labeling of warfarin or acenocoumarol.
- •Patients treated with ARBs or ACE-I within 1 month of V-1
- •Impaired renal function defined as a serum creatinine > 2.5 mg/dL
- •Evidence of hepatic disease evidenced by an AST or ALT value > 2 times the upper limit of the institution's normal values.
- •Significant non-cardiovascular illness or condition likely to result in severe incapacitation or death prior to study completion.
Outcomes
Primary Outcomes
Time to first AF recurrence on valsartan vs. placebo (time-to-event analysis, log-rank test)
Secondary Outcomes
- Number of CV attempts in order to restore SR in valsartan vs. placebo
- Total electrical energy expended in 2 groups to achieve SR
- Rate of early AF recurrence (within 24 hours) in the 2 groups after achieving SR
- Net rate of NSR in the 2 groups at 24 hours.
Investigators
Study Sites (3)
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