Secondary Prevention of Atrial Fibrillation (Impact of Renin-Angiotensin-Aldosterone System Inhibition)
Primary Purpose
Atrial Fibrillation
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
no drug
start cozaar
continue cozaar
Sponsored by
About this trial
This is an interventional other trial for Atrial Fibrillation
Eligibility 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
Sites / Locations
- UPMC CVI
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
A Group 1 no drug
A Group 2
B
Arm Description
Patients who have not taken ACE/ARB, randomized to no drug.
Patients who have not taken ACE/ARB, randomized to take cozaar.
Patients currently taking ACE/ARB will have their prescription changed to cozaar.
Outcomes
Primary Outcome Measures
AF burden
Secondary Outcome Measures
Full Information
NCT ID
NCT01233635
First Posted
November 2, 2010
Last Updated
March 22, 2023
Sponsor
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT01233635
Brief Title
Secondary Prevention of Atrial Fibrillation (Impact of Renin-Angiotensin-Aldosterone System Inhibition)
Official Title
Secondary Prevention of Atrial Fibrillation (Impact of Renin-Angiotensin-Aldosterone System Inhibition)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
inadequate enrollment rate
Study Start Date
November 2005 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh
4. Oversight
5. Study Description
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:
To confirm that RAAS inhibition therapy reduces the incidence of AF recurrence.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
228 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A Group 1 no drug
Arm Type
Experimental
Arm Description
Patients who have not taken ACE/ARB, randomized to no drug.
Arm Title
A Group 2
Arm Type
Experimental
Arm Description
Patients who have not taken ACE/ARB, randomized to take cozaar.
Arm Title
B
Arm Type
Experimental
Arm Description
Patients currently taking ACE/ARB will have their prescription changed to cozaar.
Intervention Type
Other
Intervention Name(s)
no drug
Intervention Description
none, no drug
Intervention Type
Drug
Intervention Name(s)
start cozaar
Intervention Description
start cozaar
Intervention Type
Drug
Intervention Name(s)
continue cozaar
Intervention Description
continue cozaar
Primary Outcome Measure Information:
Title
AF burden
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
UPMC CVI
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Secondary Prevention of Atrial Fibrillation (Impact of Renin-Angiotensin-Aldosterone System Inhibition)
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