Hypertrophic CardiomyopathyPhase 1NCT00001396
Natural History and Results of Dual Chamber (DDD) Pacemaker Therapy of Children With Obstructive Hypertrophic Cardiomyop...
A Phase 1 study testing Paragon Pacemaker in people with Hypertrophic Cardiomyopathy, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
Several studies have shown that specialized pacemaking devices (DDD pacing) can improve the symptoms associated with hypertrophic cardiomyopathy (HCM) in adults. In addition, studies have also shown that specialized pacemaking devices (DDD pacing) can improve conditions of HCM in children. Read more about this study
- Who is it for?
- Ages 5 to 20 years
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- What is being tested?
- Paragon Pacemaker
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 1993to 23 Jul 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children of either gender, aged 5 to 15 years.
- Presence of LV hypertrophy and LV outflow obstruction.
- Children of either gender, 5 to 20 years (children greater than 15 years will be included if there is access to reliable previous catheterization data).
- Presence of LV hypertrophy and LV obstruction.
Who cannot join
- Other systemic disease that prevent evaluation by echocardiography or cardiac catheterization.
- Chronic atrial fibrillation.
- Positive pregnancy test.
- Other systemic disease that prevent evaluation by echocardiography or cardiac catheterization.
- Chronic atrial fibrillation.
- Positive pregnancy test.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Obstructive Hypertrophic Cardiomyopathy (HCM) in Children: Natural History and Results of Dual Chamber (DDD) Pacemaker Therapy
Several studies have shown that specialized pacemaking devices (DDD pacing) can improve the symptoms associated with hypertrophic cardiomyopathy (HCM) in adults. In addition, studies have also shown that specialized pacemaking devices (DDD pacing) can improve conditions of HCM in children. However, growth of the body and organs, including the heart, is very rapid during childhood. Therefore the long-term effects of DDD pacing in children are unknown.
The purpose of this study is to examine the growth rate and nutrition of children with HCM. Due to this heart condition and the restrictions that are often placed on the child's activity level, children with HCM may grow at a slower rat and may have a greater tendency to be overweight.
Read more
Children participating in the study will have their growth rate and nutritional status measured before the study begins and throughout the course of the study.
Findings in this research study will not directly benefit the patients participating in it. However, information gathered as a result of this study may lead to improvements in the management of children with HCM in the future.
Read the detailed description
Several studies have shown that dual chamber (DDD) pacemaker therapy relieves LV outflow obstruction and improves symptoms in most adult patients with obstructive hypertrophic cardiomyopathy (HCM). It is however, uncertain whether DDD pacing will be efficacious in children with obstructive HCM, because of evolving cardiac morphology and increased LV hypertrophy and outflow obstruction associated with rapid body growth. We propose to monitor clinical progress, and cardiac morphologic and hemodynamic changes over several years following implantation of a DDD pacemaker in children who present with obstructive HCM between the ages of 5 to 15 years. Functional status, myocardial ischemia, arrhythmias, and LV outflow obstruction will be evaluated by exercise tests, echocardiography, thallium scintigraphy, Holter monitoring, electrophysiologic and cardiac catheterization studies. The results of pacemaker therapy will be compared with the findings in a cohort of young patients with obstructive HCM who elect not to be treated with DDD pacemaker.
- Conditions
- Hypertrophic Cardiomyopathy
- Being tested
- Paragon Pacemaker
- Keywords
- Pacemaker, Pediatric, Obstructive HCM
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paragon PacemakerDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start6 Oct 1993
- Study completion23 Jul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 100 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001396
- Sponsor's protocol ID
- 940001
- Other IDs
- 94-H-0001
- Status last verified
- 23 Jul 2008
- First submitted
- 3 Nov 1999
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Fananapazir L, Cannon RO 3rd, Tripodi D, Panza JA. Impact of dual-chamber permanent pacing in patients with obstructive hypertrophic cardiomyopathy with symptoms refractory to verapamil and beta-adrenergic blocker therapy. Circulation. 1992 Jun;85(6):2149-61. doi: 10.1161/01.cir.85.6.2149.
PubMed 1350522Slade AK, Sadoul N, Shapiro L, Chojnowska L, Simon JP, Saumarez RC, Dodinot B, Camm AJ, McKenna WJ, Aliot E. DDD pacing in hypertrophic cardiomyopathy: a multicentre clinical experience. Heart. 1996 Jan;75(1):44-9. doi: 10.1136/hrt.75.1.44.
PubMed 8624871McAreavey D, Fananapazir L. Altered cardiac hemodynamic and electrical state in normal sinus rhythm after chronic dual-chamber pacing for relief of left ventricular outflow obstruction in hypertrophic cardiomyopathy. Am J Cardiol. 1992 Sep 1;70(6):651-6. doi: 10.1016/0002-9149(92)90207-f.
PubMed 1510015
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Hypertrophic Cardiomyopathy (HCM) in Children: Natural History and Results of Dual Chamber (DDD) Pacemaker Therapy
- ClinicalTrials.gov ID
- NCT00001396
- Acronym / sponsor ID
- 940001
- Conditions
- Hypertrophic Cardiomyopathy
- Keywords
- Pacemaker, Pediatric, Obstructive HCM
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 6 Oct 1993
- Study completion
- 23 Jul 2008
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Several studies have shown that specialized pacemaking devices (DDD pacing) can improve the symptoms associated with hypertrophic cardiomyopathy (HCM) in adults. In addition, studies have also shown that specialized pacemaking devices (DDD pacing) can improve conditions of HCM in children. However, growth of the body and organs, including the heart, is very rapid during childhood. Therefore the long-term effects of DDD pacing in children are unknown.
The purpose of this study is to examine the growth rate and nutrition of children with HCM. Due to this heart condition and the restrictions that are often placed on the child's activity level, children with HCM may grow at a slower rat and may have a greater tendency to be overweight.
Children participating in the study will have their growth rate and nutritional status measured before the study begins and throughout the course of the study.
Findings in this research study will not directly benefit the patients participating in it. However, information gathered as a result of this study may lead to improvements in the management of children with HCM in the future.
Detailed description
Several studies have shown that dual chamber (DDD) pacemaker therapy relieves LV outflow obstruction and improves symptoms in most adult patients with obstructive hypertrophic cardiomyopathy (HCM). It is however, uncertain whether DDD pacing will be efficacious in children with obstructive HCM, because of evolving cardiac morphology and increased LV hypertrophy and outflow obstruction associated with rapid body growth. We propose to monitor clinical progress, and cardiac morphologic and hemodynamic changes over several years following implantation of a DDD pacemaker in children who present with obstructive HCM between the ages of 5 to 15 years. Functional status, myocardial ischemia, arrhythmias, and LV outflow obstruction will be evaluated by exercise tests, echocardiography, thallium scintigraphy, Holter monitoring, electrophysiologic and cardiac catheterization studies. The results of pacemaker therapy will be compared with the findings in a cohort of young patients with obstructive HCM who elect not to be treated with DDD pacemaker.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 5 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Children of either gender, aged 5 to 15 years.
- Presence of LV hypertrophy and LV outflow obstruction.
- Children of either gender, 5 to 20 years (children greater than 15 years will be included if there is access to reliable previous catheterization data).
- Presence of LV hypertrophy and LV obstruction.
Key exclusion criteria (6 listed)
- Other systemic disease that prevent evaluation by echocardiography or cardiac catheterization.
- Chronic atrial fibrillation.
- Positive pregnancy test.
- Other systemic disease that prevent evaluation by echocardiography or cardiac catheterization.
- Chronic atrial fibrillation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paragon Pacemaker | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 1350522Fananapazir L, Cannon RO 3rd, Tripodi D, Panza JA. Impact of dual-chamber permanent pacing in patients with obstructive hypertrophic cardiomyopathy with symptoms refractory to verapamil and beta-adrenergic blocker therapy. Circulation. 1992 Jun;85(6):2149-61. doi: 10.1161/01.cir.85.6.2149.
- Background: PubMed 8624871Slade AK, Sadoul N, Shapiro L, Chojnowska L, Simon JP, Saumarez RC, Dodinot B, Camm AJ, McKenna WJ, Aliot E. DDD pacing in hypertrophic cardiomyopathy: a multicentre clinical experience. Heart. 1996 Jan;75(1):44-9. doi: 10.1136/hrt.75.1.44.
- Background: PubMed 1510015McAreavey D, Fananapazir L. Altered cardiac hemodynamic and electrical state in normal sinus rhythm after chronic dual-chamber pacing for relief of left ventricular outflow obstruction in hypertrophic cardiomyopathy. Am J Cardiol. 1992 Sep 1;70(6):651-6. doi: 10.1016/0002-9149(92)90207-f.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Paragon Pacemaker in people with Hypertrophic Cardiomyopathy, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001396, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.