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Clinical Trials/NCT01233635
NCT01233635
Terminated
Phase 4

Secondary Prevention of Atrial Fibrillation (Impact of Renin-Angiotensin-Aldosterone System Inhibition)

University of Pittsburgh1 site in 1 country228 target enrollmentNovember 2005

Overview

Phase
Phase 4
Intervention
no drug
Conditions
Atrial Fibrillation
Sponsor
University of Pittsburgh
Enrollment
228
Locations
1
Primary Endpoint
AF burden
Status
Terminated
Last Updated
3 years ago

Overview

Brief Summary

In the present application, we propose to refine and extend current insight into AAF mechanism and therapy by examining the importance of pharmacologic RAAS inhibition, ACE genotype, and their interaction in secondary AF prevention. We have 3 specific aims:

  1. To confirm that RAAS inhibition therapy reduces the incidence of AF recurrence.
  2. To test the hypothesis that the incidence of AF recurrence in the absence of RAAS inhibition therapy is higher among patients with the D allele.
  3. To explore the hypothesis that RAAS inhibition therapy is more effective for preventing AF recurrence in patients with the DD genotype than in those with DI or II genotypes.
Registry
clinicaltrials.gov
Start Date
November 2005
End Date
November 2007
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Subjects must be in atrial fibrillation confirmed by 12 lead EKG.
  • blood pressure \> 90 mmHg
  • Patient without cardiopulmonary symptoms
  • 18+ years of age

Exclusion Criteria

  • Contraindiction to warfarin
  • Recent (within 6 months) MI or cardiac revascularization
  • Recent (within 6 months) CVA or TIA
  • NYHA Class IV CHF
  • Active thyroid disease
  • Major hepatic dysfunction
  • Renal dysfunction (\>2 mg/dL)
  • Hyperkalemia (\>4.6 mEq/L)
  • Hyponatremia (\<130 mEq/L)
  • Currently taking a Vaughn-Williams Type I or III antiarrhythmic drug

Arms & Interventions

A Group 1 no drug

Patients who have not taken ACE/ARB, randomized to no drug.

Intervention: no drug

A Group 2

Patients who have not taken ACE/ARB, randomized to take cozaar.

Intervention: start cozaar

B

Patients currently taking ACE/ARB will have their prescription changed to cozaar.

Intervention: continue cozaar

Outcomes

Primary Outcomes

AF burden

Time Frame: 1 year

Study Sites (1)

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