Clinical trial NCT00343499: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
valsartan
sinus rhythm
persistent atrial fibrillation undergoing electrical cardioversion to restore normal sinus rhythm
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2006-06-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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.

Primary outcomes:
measure: Time to first AF recurrence on valsartan vs. placebo (time-to-event analysis, log-rank test)
Secondary outcomes:
measure: Number of CV attempts in order to restore SR in valsartan vs. placebo
measure: Total electrical energy expended in 2 groups to achieve SR
measure: Rate of early AF recurrence (within 24 hours) in the 2 groups after achieving SR
measure: Net rate of NSR in the 2 groups at 24 hours.
Other outcomes:
Locations:
city: Ogden
country: United States
facility: McKay Dee Hospital
state: Utah
city: Salt Lake City
country: United States
facility: LDS Hospital
state: Utah
city: St. George
country: United States
facility: Dixie Regional Medical Center
state: Utah
Study officials:
affiliation: Intermountain Healthcare, LDS Hospital
name: Jeffrey L Anderson, MD
role: PRINCIPAL_INVESTIGATOR
References: