NCT00001396 is a Phase 1 clinical trial of Paragon Pacemaker in Hypertrophic Cardiomyopathy, sponsored by National Heart, Lung, and Blood Institute (NHLBI).

Who is sponsoring NCT00001396?

NCT00001396 is sponsored by National Heart, Lung, and Blood Institute (NHLBI).

What drugs are being tested in NCT00001396?

Interventions in NCT00001396: Paragon Pacemaker.

What condition does NCT00001396 study?

NCT00001396 studies Hypertrophic Cardiomyopathy.

Is NCT00001396 still recruiting?

NCT00001396 is currently completed. Last updated 2 July 2017.

Last reviewed 2017-07-02 · How we verify

NCT00001396

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Natural History and Results of Dual Chamber (DDD) Pacemaker Therapy of Children With Obstructive Hypertrophic Cardiomyop...

Completed Phase 1 Last updated 2 July 2017

What this trial tests

Phase 1 trial testing Paragon Pacemaker in Hypertrophic Cardiomyopathy in 100 participants. Completed in 23 July 2008.

Timeline

6 October 1993

23 July 2008

Quick facts

Lead sponsor	National Heart, Lung, and Blood Institute (NHLBI)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Primary purpose	treatment
Enrollment	100
Start date	6 October 1993
Estimated completion	23 July 2008
Sites	1 location across United States

Drugs / interventions tested

Paragon Pacemaker

Conditions studied

Hypertrophic Cardiomyopathy — all drugs for Hypertrophic Cardiomyopathy →

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Who can join

Adults 5 to 20, any sex, with Hypertrophic Cardiomyopathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Hypertrophic Cardiomyopathy

Currently open trials in the same condition.

NCT07361289 — A Study to Assess the Real-World Effectiveness of Mavacamten in Adult Patients With Obstructive Hypertrophic Cardiomyopa · recruiting
NCT06490250 — Comparison of the Effects of Inspiratory Muscle Training and Baduanjin Exercises in Hypertrophic Cardiomyopathy Patients · NA · recruiting
NCT06573723 — Institutional Registry of Rare Diseases · recruiting
NCT06549608 — A Retrospective Cohort Study of Mavacamten Patient Support Program in Canada · active not recruiting
NCT05939700 — Mavacamten Pregnancy Surveillance Program · recruiting

Other National Heart, Lung, and Blood Institute (NHLBI) trials

Trials by the same sponsor.

NCT07566494 — Escalating Doses of VAS-101 in Subjects With Stable Sickle Cell Disease · Phase 1 · not yet recruiting
NCT07137455 — EDEN Intracardiac Electrogram Recording and Classifying System · NA · enrolling by invitation
NCT05372627 — NHLBI-Emory Advanced Cardiac CT Reconstruction · not yet recruiting
NCT07516379 — GRAfT 2.0. A Multimodal Prospective Approach to Define the Mechanisms and Clinical Features of Acute and Chronic Rejecti · not yet recruiting
NCT06948097 — Syk Inhibition in MItigating Lung Allograft Rejection (SIMILAR): A Trial to Evaluate the Safety and Tolerability of Fost · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00001396 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI)
Last refreshed: 2 July 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00001396.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing