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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
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 2, 2010
Last Updated
March 22, 2023
Sponsor
University of Pittsburgh
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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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