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

Sponsor:	University of Pittsburgh
Information provided by (Responsible Party):	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT01233635

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:

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.

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:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

Drug Information available for: Losartan Losartan potassium

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 May 23, 2012