Dabigatran's Effect on Changes in Atrial Fibrosis in Patients With Atrial Fibrillation (DEPAF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Utah
Sponsor:
Information provided by (Responsible Party):
Nassir F. Marrouche, MD, University of Utah
ClinicalTrials.gov Identifier:
NCT01546883
First received: February 15, 2012
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

This study includes treating patients with atrial fibrillation (AF) with Dabigatran, an anti-coagulant for a period of one year to see if there are any significant changes in the degree of left atrial structural remodeling in these patients. The investigators hypothesize that there will be a significant decrease in the degree of left atrial structural remodeling (fibrosis) in AF patients treated with dabigatran.


Condition Intervention Phase
Atrial Fibrillation
Drug: Dabigatran etexilate (Pradaxa)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Dabigatran-related Effect on Progression of Atrial Fibrosis in Patients With Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Percentage of fibrosis [ Time Frame: MRI at baseline and MRI at 12 months post-enrollment ] [ Designated as safety issue: No ]
    We will measure the change in percentage of fibrosis over a one-year period when drug is taken. We will calculate the results as percentage of fibrosis measured using MRI at 12 months minus the percentage of fibrosis measured using MRI at baseline to clarify if there is a decrease in fibrosis in the one year period.


Estimated Enrollment: 30
Study Start Date: February 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dabigatran
Patients with Atrial fibrillation taking Dabigatran etexilate as the anti-coagulant
Drug: Dabigatran etexilate (Pradaxa)
150mg bid or 75mg bid for a period of one year
Other Name: Pradaxa

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with all types of non-valvular AF (includes paroxysmal, persistent and permanent AF)
  2. Candidate for anticoagulation therapy
  3. No contra-indication for LGE-MRI
  4. Patients age 18 and older
  5. Patients who are able to provide informed consent to participate in the study

Exclusion Criteria:

  1. Patients who have already undergone an atrial fibrillation ablation procedure.
  2. Patients with active contra-indications to any anticoagulant agent.
  3. Other major bleeding disorders or risk factors that would place the patient at risk of bleeding.
  4. Recent surgery (within 30 days).
  5. Renal insufficiency, severe kidney disorders/diseases, GFR < 30mg/dL (Gadolinium contraindication).
  6. Advanced liver disease.
  7. Any health related Gadolinium/MRI contraindications: Pacemaker devices, etc.
  8. Pregnant, planning to be become pregnant or nursing women
  9. Individuals who are unable to provide informed consent
  10. Contraindicated for Pradaxa® .
  11. Patients the Investigators feel are inappropriate for the study
  12. Patients who cannot give informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01546883

Contacts
Contact: Marci Fjelstad, MPH, MBA, CCRP 8012133775 Marci.Fjelstad@carma.utah.edu
Contact: Holly Johnson, MBA 8015873889 holly.johnson@carma.utah.edu

Locations
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Nassir F Marrouche, MD, FHRS University of Utah, CARMA center
  More Information

No publications provided

Responsible Party: Nassir F. Marrouche, MD, Associate Professor, University of Utah
ClinicalTrials.gov Identifier: NCT01546883     History of Changes
Other Study ID Numbers: IRB # 43119
Study First Received: February 15, 2012
Last Updated: September 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Atrial fibrillation
MRI

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Dabigatran
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014