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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
November 2, 2010
November 3, 2010
January 5, 2016
November 2005
November 2007   (Final data collection date for primary outcome measure)
AF burden [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT01233635 on ClinicalTrials.gov Archive Site
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Secondary Prevention of Atrial Fibrillation (Impact of Renin-Angiotensin-Aldosterone System Inhibition)
Secondary Prevention of Atrial Fibrillation (Impact of Renin-Angiotensin-Aldosterone System Inhibition)

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Atrial Fibrillation
  • Other: no drug
    none, no drug
  • Drug: start cozaar
    start cozaar
  • Drug: continue cozaar
    continue cozaar
  • Experimental: A Group 1 no drug
    Patients who have not taken ACE/ARB, randomized to no drug.
    Intervention: Other: no drug
  • Experimental: A Group 2
    Patients who have not taken ACE/ARB, randomized to take cozaar.
    Intervention: Drug: start cozaar
  • Experimental: B
    Patients currently taking ACE/ARB will have their prescription changed to cozaar.
    Intervention: Drug: continue cozaar
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
228
November 2007
November 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01233635
0507061
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University of Pittsburgh
University of Pittsburgh
Not Provided
Not Provided
University of Pittsburgh
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP