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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00343499
Recruitment Status : Terminated (Inability to recruit)
First Posted : June 23, 2006
Last Update Posted : August 21, 2008
Information provided by:
Intermountain Health Care, Inc.

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)

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Valsartan

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00343499

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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.
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Principal Investigator: Jeffrey L Anderson, MD Intermountain Healthcare, LDS Hospital
Layout table for additonal information Identifier: NCT00343499    
Other Study ID Numbers: 128-011
First Posted: June 23, 2006    Key Record Dates
Last Update Posted: August 21, 2008
Last Verified: August 2008
Keywords provided by Intermountain Health Care, Inc.:
atrial fibrillation
sinus rhythm
persistent atrial fibrillation undergoing electrical cardioversion to restore normal sinus rhythm
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action