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

NCT ID: NCT01233635

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2007-11-30

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

A Group 1 no drug

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

Group Type: EXPERIMENTAL

no drug

Intervention Type: OTHER

none, no drug

A Group 2

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

Group Type: EXPERIMENTAL

start cozaar

Intervention Type: DRUG

start cozaar

B

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

Group Type: EXPERIMENTAL

continue cozaar

Intervention Type: DRUG

continue cozaar

Interventions

no drug

none, no drug

Intervention Type: OTHER

start cozaar

start cozaar

Intervention Type: DRUG

continue cozaar

continue cozaar

Intervention Type: DRUG

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UPMC CVI

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

0507061

Identifier Type: -

Identifier Source: org_study_id