- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001960
Studying the Effectiveness of Pacemaker Therapy in Children Who Have Thickened Heart Muscle
Controlled Cross-Over Study of DDD Pacemaker Therapy in Symptomatic Children With Obstructive Hypertrophic Cardiomyopathy
A heart condition called hypertrophic cardiomyopathy (HCM) causes abnormal thickening of the heart muscle, which obstructs the flow of blood out of the heart. The thickened muscle and the obstruction of blood flow are believed to cause chest discomfort, breathlessness, fainting, and a sensation of heart pounding. Treatment options for children with HCM include medicine, heart operation, and cardiac transplantation. However, there is no evidence that medicine prevents further thickening of heart muscle; operations carry the risk of death; and donor hearts are not always available. Several studies have shown that pacemaker treatment reduces the obstruction and improves heart complaints in patients with HCM. This study investigates further the efficacy of pacemaker treatment in children.
Patients will have exercise tests after treatment with beta blocker and verapamil and will be eligible for the study if heart complaints or reduced exercise performance continue.
A pacemaker that treats slow heart rhythms will be inserted. The patient will be sedated and local anesthesia will be administered to numb the area. The procedure takes about an hour.
The study will last two years. Patients will be placed on one of two pacemaker programs for the first year and another the second year. At 3- and 6-month follow-up visits, a pacemaker check and echocardiogram will be performed. After 1 year, patients will be admitted to NIH for 2 to 3 days for exercise tests, echocardiogram, and cardiac catheterization. Also, the pacemaker will be changed to the second program. At 15- and 18-month follow-up visits, a pacemaker check and echocardiogram will be performed. After 2 years, patients will again be admitted for 2 to 3 days for exercise tests, echocardiogram, and cardiac catheterization. A pregnancy test will be given to females of child-bearing age before each cardiac catheterization and electrophysiology study.
At the end of the study, the pacemaker will be set to the program that worked better.
Risks of pacemaker insertion include lung collapse, infection, blood vessel damage, bleeding, heart attack, and death. Risks of cardiac catheterization include infection, bleeding, blood clots, abnormal heart rhythms, perforation of the heart, need for surgery, and death. However, the safety record for both these procedures at NIH has been excellent. The radiation exposure exceeds the NIH radiation guidelines for children, but this exposure in adults has not been associated with any definite adverse effects.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Heart, Lung and Blood Institute (NHLBI)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA:
Children of either gender, aged 4 to 18 years.
Obstructive HCM defined as LV hypertrophy, and an LV intra-cavitary pressure gradient measured at cardiac catheterization of greater than or equal to 30 mm Hg at rest or greater than or equal to 50 mm Hg following isoproterenol infusion to a heart rate of greater than or equal to 100 beats per minute.
Cardiac symptoms (chest discomfort, dyspnea, lightheadedness or presyncope, syncope, cardio-respiratory arrest, palpitations, excessive fatigue); and/or exercise duration which is less than 10th percentile predicted for age/gender despite a trial of a beta-blocker therapy and a trial of verapamil therapy.
EXCLUSION CRITERIA:
Other systemic diseases that prevent assessment by exercise tests and cardiac catheterization.
Chronic atrial fibrillation.
Positive pregnancy test: A negative urine pregnancy test will be required before each cardiac catheterization, electrophysiologic study and thallium study. Pregnant or lactating subjects may not participate in the study due to potential teratogenic effects of radiation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
Collaborators and Investigators
Publications and helpful links
General Publications
- Fananapazir L, Chang AC, Epstein SE, McAreavey D. Prognostic determinants in hypertrophic cardiomyopathy. Prospective evaluation of a therapeutic strategy based on clinical, Holter, hemodynamic, and electrophysiological findings. Circulation. 1992 Sep;86(3):730-40. doi: 10.1161/01.cir.86.3.730.
- Wigle ED, Rakowski H, Kimball BP, Williams WG. Hypertrophic cardiomyopathy. Clinical spectrum and treatment. Circulation. 1995 Oct 1;92(7):1680-92. doi: 10.1161/01.cir.92.7.1680.
- Fananapazir L. Advances in molecular genetics and management of hypertrophic cardiomyopathy. JAMA. 1999 May 12;281(18):1746-52. doi: 10.1001/jama.281.18.1746. No abstract available. Erratum In: JAMA 1999 Dec 22-29;282(24):2303.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 000007
- 00-H-0007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertrophic Cardiomyopathy
-
French Cardiology SocietyCompleted1- Primary (Sarcomeric) Hypertrophic Cardiomyopathy | 2- Obstructive Hypertrophic Cardiomyopathy | 3- Non Obstructive Hypertrophic CardiomyopathyFrance
-
Montreal Heart InstituteCanadian Institutes of Health Research (CIHR)Enrolling by invitationCardiomyopathies | Hypertrophic Cardiomyopathy | Hypertrophic Obstructive Cardiomyopathy | Familial Hypertrophic CardiomyopathyCanada
-
University of Sao PauloCompletedNon-obstructive Hypertrophic Cardiomyopathy | Obstructive Hypertrophic CardiomyopathyBrazil
-
Bristol-Myers SquibbActive, not recruitingHypertrophic Cardiomyopathy | Non-obstructive Hypertrophic Cardiomyopathy | Obstructive Hypertrophic CardiomyopathyDenmark, United States, Belgium, Czechia, France, Germany, Israel, Italy, Netherlands, Poland, Portugal, Spain, United Kingdom
-
Yonsei UniversityCompletedFamilial Hypertrophic CardiomyopathyKorea, Republic of
-
Hangzhou Valgen Medtech Co., LtdNot yet recruitingObstructive Hypertrophic CardiomyopathyChina
-
China National Center for Cardiovascular DiseasesNot yet recruitingObstructive Hypertrophic Cardiomyopathy
-
Bristol-Myers SquibbNot yet recruitingObstructive Hypertrophic CardiomyopathyKorea, Republic of
-
Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.RecruitingObstructive Hypertrophic CardiomyopathyChina
-
Xiang WeiRecruitingNonobstructive Hypertrophic CardiomyopathyChina
Clinical Trials on Pacemaker therapy
-
Biotronik SE & Co. KGCompletedCardiac Pacemaker SyndromeGermany
-
Gianluca BottoUnknownFirst Degree Atrioventricular BlockItaly
-
Columbia UniversityMedtronicTerminated
-
Cardiff and Vale University Health BoardNorfolk and Norwich University Hospitals NHS Foundation Trust; Cardiff Metropolitan...Enrolling by invitation
-
Biotronik SE & Co. KGCompletedArrhythmias, CardiacHungary
-
Medtronic Bakken Research CenterCompletedHeart Failure
-
Biotronik SE & Co. KGCompleted
-
Yong-Mei ChaNational Heart, Lung, and Blood Institute (NHLBI); Biotronik SE & Co. KGCompleted
-
Ajou University School of MedicineRecruitingObesity | Arrhythmias, Cardiac | Cardiovascular Morbidity | Pacemaker ComplicationKorea, Republic of