Clincosm LogoSign in Get a demo

Pilot Study Using Echocardiography to Evaluate Patients With Heart Failure and Dyssynchrony Who Have a CRT-D Device

Sponsor
University of Mississippi Medical Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01127334
Collaborator
(none)
0
Enrollment
1
Location
12
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Out of all the patients that receive a CRT-D ( a dual chamber pacemaker with defibrillator ) for cardiac resynchronization therapy there is approximately one-third that do not respond. We believe that by using a simple technique that includes routine echocardiography that are normally performed in these patients could help us better understand how to program their device to reach better optimization.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    0 participants
    Time Perspective:
    Prospective
    Official Title:
    Validation of a Robust Method for Kinematic Analysis of Ventricular Mechanical Dyssynchrony by Two Dimensional Echocardiography in Patients With Cardiac Resynchronization Devices for Chronic Systolic Heart Failure and Conduction System Disease
    Study Start Date :
    May 1, 2010
    Actual Primary Completion Date :
    May 1, 2011
    Actual Study Completion Date :
    May 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    Systolic Heart Failure, Dyssynchrony, CRT-D

    Patients with systolic heart failure and dyssynchrony that have a CRT-D that have not been optimized in the past 3 months.

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      1. Adults age 18-110 years

      2. Must have a CRT-D (A biventricular pacemaker with defibrillator)

      3. Last optimization of their device (CRT-D) must not have been done in the past 3 months

      4. Must be optimal heart failure medical regimen. This includes target dose of beta-blocker and angiotensin converting enzyme inhibitor (ACE-I) (or equivalent; i.e angiotensin receptor blocker (ARB); or balanced preload and afterload reducers with hydralazine and nitrates.)

      Exclusion Criteria:

      1. Less than 18 years of age or greater than 110 years old.

      2. Does not have a CRT-D

      3. Optimization of their device has occurred in the past 3 months

      4. Not on optimal medical therapy for heart failure as listed in the inclusion criteria.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 University of Mississippi Medical Center Jackson Mississippi United States 39216

      Sponsors and Collaborators

      • University of Mississippi Medical Center

      Investigators

      • Principal Investigator: Donny R. Stokes, M.D., University of Mississippi Medical Center
      • Study Director: John P. Payne, M.D., University of Mississippi Medical Center

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01127334
      Other Study ID Numbers:
      • 2010-0069
      First Posted:
      May 20, 2010
      Last Update Posted:
      Apr 4, 2012
      Last Verified:
      May 1, 2010
      Keywords provided by , ,
      Dyssynchrony
      Cardiac resynchronization therapy
      Additional relevant MeSH terms:
      Heart Failure
      Heart Failure, Systolic
      Systolic Murmurs

      Study Results

      No Results Posted as of Apr 4, 2012