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

This study has been terminated.
(Inability to recruit)
Sponsor:
Collaborator:
Novartis
Information provided by:
Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier:
NCT00343499
First received: June 21, 2006
Last updated: August 20, 2008
Last verified: August 2008
  Purpose

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 Intervention Phase
Atrial Fibrillation
Drug: valsartan
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Intermountain Health Care, Inc.:

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 200
Study Start Date: November 2004
Study Completion Date: July 2007
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00343499

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

No publications provided

ClinicalTrials.gov Identifier: NCT00343499     History of Changes
Other Study ID Numbers: 128-011
Study First Received: June 21, 2006
Last Updated: August 20, 2008
Health Authority: United States: Food and Drug Administration

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
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014