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

March 22, 2023 updated by: University of Pittsburgh

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

228

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC CVI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A Group 1 no drug
Patients who have not taken ACE/ARB, randomized to no drug.
Other: no drug
none, no drug
Experimental: A Group 2
Patients who have not taken ACE/ARB, randomized to take cozaar.
Drug: start cozaar
start cozaar
Experimental: B
Patients currently taking ACE/ARB will have their prescription changed to cozaar.
Drug: continue cozaar
continue cozaar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AF burden
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

November 2, 2010

First Submitted That Met QC Criteria

November 2, 2010

First Posted (Estimate)

November 3, 2010

Study Record Updates

Last Update Posted (Actual)

March 23, 2023

Last Update Submitted That Met QC Criteria

March 22, 2023

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0507061

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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