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

This study has been terminated.
(inadequate enrollment rate)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01233635
First Posted: November 3, 2010
Last Update Posted: January 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Pittsburgh
  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: None (Open Label)
Official Title: Secondary Prevention of Atrial Fibrillation (Impact of Renin-Angiotensin-Aldosterone System Inhibition)

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • AF burden [ Time Frame: 1 year ]

Estimated Enrollment: 228
Study Start Date: November 2005
Study Completion Date: November 2007
Primary Completion Date: November 2007 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01233635


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

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01233635     History of Changes
Other Study ID Numbers: 0507061
First Submitted: November 2, 2010
First Posted: November 3, 2010
Last Update Posted: January 5, 2016
Last Verified: January 2016

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