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

Phase 4

Terminated

• Conditions: Atrial Fibrillation
• Interventions: Drug: start cozaar; Drug: continue cozaar; Other: no drug

• Registration Number: NCT01233635
• Lead Sponsor: University of Pittsburgh

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Study First Submitted: 2010-11-02
• Study First Submitted QC: 2010-11-02
• Study First Posted: 2010-11-03
• Status Verified: 2016-01
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 228

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

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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
• History of ARB intolerance
• Contraindication to ARB therapy
• Pregnancy
• Female of childbearing age
• Age < 18 years of age
• Inability to give informed consent
• Other medical conditions calling 1 year survival into question

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A Group 2	start cozaar	Patients who have not taken ACE/ARB, randomized to take cozaar.
B	continue cozaar	Patients currently taking ACE/ARB will have their prescription changed to cozaar.
A Group 1 no drug	no drug	Patients who have not taken ACE/ARB, randomized to no drug.

Primary Outcome Measures

Name	Time	Method
AF burden	1 year

Trial Locations

Locations (1)

UPMC CVI; 🇺🇸 Pittsburgh, Pennsylvania, United States