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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01233635
• Other study ID #: 0507061
• Status: Terminated
• Phase: Phase 4
• Start date: November 2005
• Est. completion date: November 2007

Study information

• Verified date: January 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 228
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• no drug
none, no drug

Drug:
• start cozaar
start cozaar
• continue cozaar
continue cozaar

Locations

Country	Name	City	State
United States	UPMC CVI	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AF burden		1 year