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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01233635
First received: November 2, 2010
Last updated: November 21, 2011
Last verified: November 2011
History of Changes
  Purpose

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.

Condition Intervention Phase
Atrial Fibrillation
 Other: no drug
Drug: start cozaar
Drug: continue cozaar
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Secondary Prevention of Atrial Fibrillation (Impact of Renin-Angiotensin-Aldosterone System Inhibition)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • AF burden [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 228
Study Start Date: November 2005
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01233635

Locations
United States, Pennsylvania
UPMC CVI
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01233635     History of Changes
Other Study ID Numbers: 0507061
Study First Received: November 2, 2010
Last Updated: November 21, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Losartan
Anti-Arrhythmia Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013