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

NCT ID: NCT00343499

Last Updated: 2008-08-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2007-07-31

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)

Conditions

Atrial Fibrillation

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

valsartan

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Intermountain Health Care, Inc.

OTHER

Sponsor Role: lead

Principal Investigators

Jeffrey L Anderson, MD

Role: PRINCIPAL_INVESTIGATOR

Intermountain Healthcare, LDS Hospital

Locations

McKay Dee Hospital

Ogden, Utah, United States

LDS Hospital

Salt Lake City, Utah, United States

Dixie Regional Medical Center

St. George, Utah, United States

Countries

United States

Other Identifiers

128-011

Identifier Type: -

Identifier Source: org_study_id