Atrial Fibrillation
Conditions
Keywords
atrial fibrillation, valsartan, sinus rhythm, persistent atrial fibrillation undergoing electrical cardioversion to restore normal sinus rhythm
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)
Interventions
DRUGvalsartan
Sponsors
Novartis
Intermountain Health Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 V1. * Stroke, deep vein thrombosis (DVT), pulmonary embolism (PE) or transient ischemic attack (TIA) within 3 months of V1. * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first AF recurrence on valsartan vs. placebo (time-to-event analysis, log-rank test) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United States
Outcome results
None listed