search
Back to results

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

Primary Purpose

Atrial Fibrillation

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
valsartan
Sponsored by
Intermountain Health Care, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, valsartan, sinus rhythm, persistent atrial fibrillation undergoing electrical cardioversion to restore normal sinus rhythm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • McKay Dee Hospital
  • LDS Hospital
  • Dixie Regional Medical Center

Outcomes

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.

Full Information

First Posted
June 21, 2006
Last Updated
August 20, 2008
Sponsor
Intermountain Health Care, Inc.
Collaborators
Novartis
search

1. Study Identification

Unique Protocol Identification Number
NCT00343499
Brief Title
The Use of DIOVAN to Reduce Post-Cardioversion Recurrence of Atrial Fibrillation Trial (the DRAFT Trial)
Official Title
A Single Center, Randomized Trial to Evaluate the Effects of Diovan to Maintain Sinus Rhythm in Patients With Persistent Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Terminated
Why Stopped
Inability to recruit
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Intermountain Health Care, Inc.
Collaborators
Novartis

4. Oversight

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, valsartan, sinus rhythm, persistent atrial fibrillation undergoing electrical cardioversion to restore normal sinus rhythm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey L Anderson, MD
Organizational Affiliation
Intermountain Healthcare, LDS Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McKay Dee Hospital
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
Dixie Regional Medical Center
City
St. George
State/Province
Utah
ZIP/Postal Code
84770
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs