Treatment of Preclinical Hypertrophic Cardiomyopathy With Diltiazem

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Children's Hospital Boston
Information provided by (Responsible Party):
Carolyn Yung Ho, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00319982
First received: April 27, 2006
Last updated: February 14, 2013
Last verified: February 2013
  Purpose

This is a pilot clinical study to assess whether the administration of diltiazem may be able to decrease the development or progression of hypertrophic cardiomyopathy (HCM). Diltiazem is a commonly used medication for the treatment of high blood pressure and studies on animals with HCM suggest that diltiazem decreases disease development. This study specifically targets individuals in the "prehypertrophic" phase of HCM-- those with documented sarcomere gene mutations without echocardiographic or EKG evidence of LVH.

The hypothesis of this study is that starting diltiazem administration early in life (in the prehypertrophic phase) will decrease the progression of HCM in individuals with sarcomere gene mutations. This will be assessed by looking at an improvement in the heart's ability to relax using echocardiography.


Condition Intervention Phase
Hypertrophic Cardiomyopathy
Drug: Diltiazem
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Preclinical Hypertrophic Cardiomyopathy With Diltiazem

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Improvement, stability of, or decrease in the decline of diastolic function as reflected by the averaged early myocardial relaxation (Ea) velocity compared to baseline [ Time Frame: 6, and 18 months, annually and at study end ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement of Ea velocities [ Time Frame: 6, and 18 months, annually and at study end ] [ Designated as safety issue: No ]
  • Stability of Ea velocities [ Time Frame: 6, and 18 months, annually and at study end ] [ Designated as safety issue: No ]
  • Attenuation of the decline of Ea velocities [ Time Frame: 6, and 18 months, annually and at study end ] [ Designated as safety issue: No ]
  • Delayed or Attenuated development of left ventricular hypertrophy [ Time Frame: 6, and 18 months, annually and at study end ] [ Designated as safety issue: No ]
  • Improvement in, stability of, or attenuation of increase in serum biomarkers (ANP, BNP, and markers of mechanical stress and collagen turnover) [ Time Frame: Annual visits ] [ Designated as safety issue: No ]
  • Improvement in, stability of or attenuation of increase in MRI evidence of myocardial fibrosis [ Time Frame: Study end ] [ Designated as safety issue: No ]
  • Safety: no excess of all cause death, CV death (including sudden death), heart failure requiring medication or hospitalization [ Time Frame: Biannually ] [ Designated as safety issue: Yes ]
  • Tolerability: no excess need to reduce or withdraw study medication [ Time Frame: Biannually ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2006
Estimated Study Completion Date: December 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I Drug: Diltiazem
Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
Placebo Comparator: II
Placebo Comparator
Drug: Placebo
Placebo comparator (double-blind allocation of study medication)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   5 Years to 39 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Preclinical HCM (identified sarcomere mutation with no clinical evidence of left ventricular hypertrophy)
  • Able to provide informed consent (or parental consent)

Exclusion Criteria:

  • Contraindication to diltiazem administration
  • Impaired hepatic or renal function
  • Age < 5 years
  • Pregnant or breastfeeding women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00319982

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Children's Hospital Boston
Investigators
Principal Investigator: Carolyn Y Ho, MD Brigham and Women's Hospital
  More Information

Publications:
Responsible Party: Carolyn Yung Ho, MD, Associate Physician, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00319982     History of Changes
Other Study ID Numbers: 001936
Study First Received: April 27, 2006
Last Updated: February 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Brigham and Women's Hospital:
Hypertrophic Cardiomyopathy
Left ventricular hypertrophy
Diltiazem

Additional relevant MeSH terms:
Cardiomyopathy, Hypertrophic
Hypertrophy
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases
Pathological Conditions, Anatomical
Diltiazem
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on August 20, 2014