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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00343499
• Other study ID #: 128-011
• Status: Terminated
• Phase: Phase 4
• First received: June 21, 2006
• Last updated: August 20, 2008
• Start date: November 2004
• Est. completion date: July 2007

Study information

• Verified date: August 2008
• Source: Intermountain Health Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• valsartan

Locations

Country	Name	City	State
United States	McKay Dee Hospital	Ogden	Utah
United States	LDS Hospital	Salt Lake City	Utah
United States	Dixie Regional Medical Center	St. George	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.	Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first AF recurrence on valsartan vs. placebo (time-to-event analysis, log-rank test)
Secondary	Number of CV attempts in order to restore SR in valsartan vs. placebo
Secondary	Total electrical energy expended in 2 groups to achieve SR
Secondary	Rate of early AF recurrence (within 24 hours) in the 2 groups after achieving SR
Secondary	Net rate of NSR in the 2 groups at 24 hours.