The Use of DIOVAN to Reduce Post-Cardioversion Recurrence of Atrial Fibrillation Trial (the DRAFT Trial)

Condition(s) targeted: Atrial Fibrillation

Intervention: valsartan (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Intermountain Health Care, Inc.

Official(s) and/or principal investigator(s):
Jeffrey L Anderson, MD, Principal Investigator, Affiliation: Intermountain Healthcare, LDS Hospital

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).

Official title: A Single Center, Randomized Trial to Evaluate the Effects of Diovan to Maintain Sinus Rhythm in Patients With Persistent Atrial Fibrillation

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Time to first AF recurrence on valsartan vs. placebo (time-to-event analysis, log-rank test)

Secondary outcome:

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.

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)

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

McKay Dee Hospital, Ogden, Utah 84403, United States

LDS Hospital, Salt Lake City, Utah 84143, United States

Dixie Regional Medical Center, St. George, Utah 84770, United States

Starting date: November 2004
Last updated: August 20, 2008