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

• ClinicalTrials.gov Identifier: NCT00343499
• Recruitment Status: Terminated
• First Posted: June 23, 2006
• Last Update Posted: August 21, 2008
• Sponsor: Intermountain Health Care, Inc.
• Collaborator: Novartis
• Information provided by: Intermountain Health Care, Inc.

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Atrial Fibrillation	Drug: valsartan	Phase 4

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 (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• 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
• Study Start Date: November 2004
• Actual Study Completion Date: July 2007

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Number of CV attempts in order to restore SR in valsartan vs. placebo
2. Total electrical energy expended in 2 groups to achieve SR
3. Rate of early AF recurrence (within 24 hours) in the 2 groups after achieving SR
4. Net rate of NSR in the 2 groups at 24 hours.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

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

Sponsors and Collaborators

Intermountain Health Care, Inc.

Novartis

Investigators

• Principal Investigator: Jeffrey L Anderson, MD; Intermountain Healthcare, LDS Hospital

More Information

• ClinicalTrials.gov Identifier: NCT00343499
• Other Study ID Numbers: 128-011
• First Posted: June 23, 2006
• Last Update Posted: August 21, 2008
• Last Verified: August 2008

Keywords provided by Intermountain Health Care, Inc.:

atrial fibrillation; valsartan; sinus rhythm; persistent atrial fibrillation undergoing electrical cardioversion to restore normal sinus rhythm

Additional relevant MeSH terms:

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Valsartan; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Molecular Mechanisms of Pharmacological Action