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

NCT00343499 | Terminated Phase 4

• 1 other identifier: 128-011
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

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).

Conditions

Atrial Fibrillation

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

• 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.

Interventions

valsartan DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead
• Novartis: collaborator

Study Sites (3)

McKay Dee Hospital

Ogden, Utah, 84403, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Dixie Regional Medical Center

St. George, Utah, 84770, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Valsartan

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Jeffrey L Anderson, MD

  Intermountain Healthcare, LDS Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 21, 2006
• First Posted: June 23, 2006
• Study Start: November 1, 2004
• Study Completion: July 1, 2007
• Last Updated: August 21, 2008

Record last verified: 2008-08

Locations

US (3)