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Exercise in Chronically Paced Children
This study is ongoing, but not recruiting participants.
First Received: September 8, 2006   Last Updated: September 10, 2008   History of Changes
Sponsors and Collaborators: Emory University
Children's Healthcare of Atlanta
Information provided by: Emory University
ClinicalTrials.gov Identifier: NCT00374608
  Purpose

The purpose of this study is to evaluate the exercise capacity of patients with complete heart block who are chronically being paced from the right ventricle. Also, we hope to correlate the level of uncoordinated contraction with the patients exercise capacity. We will enroll patients with complete heart block as diagnosed by standard electrocardiographic means and now have a permanent pacemaker. All patients we approach for this study will receive an echocardiogram to assess their heart function. As part of the echocardiogram, they will also receive a Tissue Synchronization Imaging (TSI) evaluation to assess the level of uncoordinated contraction they have. The patients will then be subjected to a cardiac exercise stress test which will involve them running on a treadmill until they cannot continue while data is collected regarding their heart's response to exercise. All portions of the study are noninvasive, which means they work from probes and monitors outside the body.


Condition Intervention
Congenital Diseases
Complete Heart Block
Pacemaker
Procedure: Exercise testing
Procedure: Echo

Genetics Home Reference related topics: Brugada syndrome short QT syndrome
MedlinePlus related topics: Exercise and Physical Fitness
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: A Single Center, Prospective, Pilot Study Examining the Evaluation of Exercise Capacity in Chronically RV Paced Children and Young Adults

Further study details as provided by Emory University:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 30
Study Start Date: January 2007
Intervention Details:
    Procedure: Exercise testing
    pt will complete an exercise treadmill test
    Procedure: Echo
    pt will complete an echocardiogram
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   10 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

pt who have congenital complete heart block with no other preexisting condition that precludes the patient from exercise

Criteria

Inclusion Criteria:

  • between 10 and 21 years of age
  • structurally normal heart
  • congenital complete heart block
  • dual chamber pacemaker, right ventricular apex paced
  • normal function via traditional transthoracic echocardiography

Exclusion Criteria:

  • preexisting condition that precludes patient from exercise
  • no informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00374608

Locations
United States, Georgia
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Children's Healthcare of Atlanta
Investigators
Principal Investigator: Patricio A Frias, MD Emory University and Children's Healthcare of Atlanta
  More Information

Publications:
Ijiri H, Komori S, Kohno I, Sano S, Yin D, Takusagawa M, Iida T, Yamamoto K, Osada M, Sawanobori T, Ishihara T, Umetani K, Tamura K. Improvement of exercise tolerance by single lead VDD pacemaker: evaluation using cardiopulmonary exercise test. Pacing Clin Electrophysiol. 2000 Sep;23(9):1336-42.
Sulke N, Dritsas A, Bostock J, Wells A, Morris R, Sowton E. "Subclinical" pacemaker syndrome: a randomised study of symptom free patients with ventricular demand (VVI) pacemakers upgraded to dual chamber devices. Br Heart J. 1992 Jan;67(1):57-64.
Lee MA, Dae MW, Langberg JJ, Griffin JC, Chin MC, Finkbeiner WE, O'Connell JW, Botvinick E, Scheinman MM, Rosenqvist M. Effects of long-term right ventricular apical pacing on left ventricular perfusion, innervation, function and histology. J Am Coll Cardiol. 1994 Jul;24(1):225-32.
Bax JJ, Ansalone G, Breithardt OA, Derumeaux G, Leclercq C, Schalij MJ, Sogaard P, St John Sutton M, Nihoyannopoulos P. Echocardiographic evaluation of cardiac resynchronization therapy: ready for routine clinical use? A critical appraisal. J Am Coll Cardiol. 2004 Jul 7;44(1):1-9. Review.
Saxon LA, De Marco T, Schafer J, Chatterjee K, Kumar UN, Foster E; VIGOR Congestive Heart Failure Investigators. Effects of long-term biventricular stimulation for resynchronization on echocardiographic measures of remodeling. Circulation. 2002 Mar 19;105(11):1304-10.
Waggoner AD, Bierig SM. Tissue Doppler imaging: a useful echocardiographic method for the cardiac sonographer to assess systolic and diastolic ventricular function. J Am Soc Echocardiogr. 2001 Dec;14(12):1143-52. Review.
Wonisch M, Lercher P, Scherr D, Maier R, Pokan R, Hofmann P, von Duvillard SP. Influence of permanent right ventricular pacing on cardiorespiratory exercise parameters in chronic heart failure patients with implanted cardioverter defibrillators. Chest. 2005 Mar;127(3):787-93.
Thambo JB, Bordachar P, Garrigue S, Lafitte S, Sanders P, Reuter S, Girardot R, Crepin D, Reant P, Roudaut R, Jais P, Haissaguerre M, Clementy J, Jimenez M. Detrimental ventricular remodeling in patients with congenital complete heart block and chronic right ventricular apical pacing. Circulation. 2004 Dec 21;110(25):3766-72. Epub 2004 Dec 6.
Yu CM, Lin H, Fung WH, Zhang Q, Kong SL, Sanderson JE. Comparison of acute changes in left ventricular volume, systolic and diastolic functions, and intraventricular synchronicity after biventricular and right ventricular pacing for heart failure. Am Heart J. 2003 May;145(5):E18.
Cazeau S, Leclercq C, Lavergne T, Walker S, Varma C, Linde C, Garrigue S, Kappenberger L, Haywood GA, Santini M, Bailleul C, Daubert JC; Multisite Stimulation in Cardiomyopathies (MUSTIC) Study Investigators. Effects of multisite biventricular pacing in patients with heart failure and intraventricular conduction delay. N Engl J Med. 2001 Mar 22;344(12):873-80.

Responsible Party: Emory University ( Dr. Patrico Frias )
Study ID Numbers: 291-2006
Study First Received: September 8, 2006
Last Updated: September 10, 2008
ClinicalTrials.gov Identifier: NCT00374608     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
pediatric
congenital complete heart block
dual chamber pacemaker

Study placed in the following topic categories:
Heart Diseases
Heart Block
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Pathologic Processes
Heart Diseases
Heart Block
Cardiovascular Diseases
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on May 07, 2009