Exercise in Chronically Paced Children

NCT00374608 | Completed

• 1 other identifier: 291-2006
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congenital Diseases; Complete Heart Block; Pacemaker

Keywords

pediatric; congenital complete heart block; dual chamber pacemaker

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• preexisting condition that precludes patient from exercise
• no informed consent

Sponsors & Collaborators

• Emory University: lead
• Children's Healthcare of Atlanta: collaborator

Study Sites (1)

Children's Healthcare of Atlanta - Egleston

Atlanta, Georgia, 30322, United States

Location

Related Publications (10)

• 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. doi: 10.1111/j.1540-8159.2000.tb00960.x.

  PMID: 11025888 BACKGROUND

• 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. doi: 10.1136/hrt.67.1.57.

  PMID: 1739528 BACKGROUND

• 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. doi: 10.1016/0735-1097(94)90567-3.

  PMID: 8006270 BACKGROUND

• 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. doi: 10.1016/j.jacc.2004.02.055.

  PMID: 15234396 BACKGROUND

• 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. doi: 10.1161/hc1102.105730.

  PMID: 11901040 BACKGROUND

• 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. doi: 10.1067/mje.2001.115391.

  PMID: 11734780 BACKGROUND

• 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. doi: 10.1378/chest.127.3.787.

  PMID: 15764758 BACKGROUND

• 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. doi: 10.1161/01.CIR.0000150336.86033.8D. Epub 2004 Dec 6.

  PMID: 15583083 BACKGROUND

• 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. doi: 10.1016/S0002-8703(03)00071-1.

  PMID: 12766742 BACKGROUND

• 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. doi: 10.1056/NEJM200103223441202.

  PMID: 11259720 BACKGROUND

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Congenital heart block

Study Officials

• Patricio A Frias, MD

  Emory University and Children's Healthcare of Atlanta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Pediatrics

Study Record Dates

• First Submitted: September 8, 2006
• First Posted: September 11, 2006
• Study Start: January 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: June 1, 2012

Record last verified: 2012-05

Locations

US (1)