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

NCT01233635 | Terminated Phase 4

• 1 other identifier: 0507061
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

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. 1.To confirm that RAAS inhibition therapy reduces the incidence of AF recurrence.
2. 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. 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

Outcome Measures

Primary Outcomes (1)

• AF burden

  1 year

Study Arms (3)

A Group 1 no drug

EXPERIMENTAL

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

Other: no drug

A Group 2

EXPERIMENTAL

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

Drug: start cozaar

B

EXPERIMENTAL

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

Drug: continue cozaar

Interventions

no drug OTHER

none, no drug

A Group 1 no drug

start cozaar DRUG

start cozaar

A Group 2

continue cozaar DRUG

continue cozaar

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC CVI

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2010
• First Posted: November 3, 2010
• Study Start: November 1, 2005
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: March 23, 2023

Record last verified: 2016-01

Locations

US (1)