NCT01233635
Terminated
Phase 4
Secondary Prevention of Atrial Fibrillation (Impact of Renin-Angiotensin-Aldosterone System Inhibition)
ConditionsAtrial Fibrillation
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:
- To confirm that RAAS inhibition therapy reduces the incidence of AF recurrence.
- 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.
- 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.
Investigators
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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