Patients' Long-Term Survival of Obstructive Hypertrophic Cardiomyopathy (HCM)

Sponsor
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
Overall Status
Completed
CT.gov ID
NCT04603521
Collaborator
(none)
325
1
18.2
17.9

Study Details

Study Description

Brief Summary

Background:

HCM is a genetic heart disease. It can cause fatigue, chest pain, or even death. For more than 50 years, a surgery called septal myectomy has been used to help people with this disease. Dr. Andrew G. Morrow originated the surgery and performed it more than 200 times at NIH starting in 1960. Researchers want to learn the long-term success of this surgery.

Objective:

To determine long-term survival at least 35 years after surgical myectomy at NIH and examine data for people who are confirmed to be deceased or alive.

Eligibility:

People who had surgical myectomy by Dr. Morrow from 1960 to 1983.

Design:

This study uses images and data that were obtained in the past. Many of the participants are deceased. Most of the others are no longer being followed at the NIH.

The medical records of people treated by Dr. Morrow were microfiched. These records can be accessed at the NIH. The records will be searched for keywords to find participants for this study.

Participants clinical data, such as lab testing and imaging, will be used. Other data collected as part of the original study will also be used.

Researchers will use participants name, date of birth, and Social Security number to learn if they are alive or deceased. If they are deceased, researchers will try to find the age of death. Online databases and search engines will also be used. Survival data will be compared to data from the general U.S. population for the same time period.

Data will be stored in a database that is password protected.

The study will last about 1 year.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Hypertrophic cardiomyopathy (HCM) is a relatively common autosomal dominant genetic heart disease which may produce lifestyle limiting symptoms or even death. Medication can sometimes be of benefit, but surgical intervention with septal myectomy has been an alternative intervention. The experience with this surgery at NIH provides a unique opportunity to evaluate the long-term success of this operation.Dr. Andrew G. Morrow was the originator of this operation and performed over 200 septal myectomies at NIH starting in 1960. Reviewing the results of his experience will provide important information regarding the benefits of this intervention in these patients.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    325 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Retrospective Study of Patients Long-Term Survival of Obstructive Hypertrophic Cardiomyopathy (HCM)
    Actual Study Start Date :
    Oct 20, 2020
    Actual Primary Completion Date :
    Mar 14, 2022
    Actual Study Completion Date :
    Apr 26, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Hypertrophic cardiomyopathy (HCM)

    Survival after Myectomy Operation

    Outcome Measures

    Primary Outcome Measures

    1. Long term survival after surgical myectomy at NIH [Enrolled NIH subjects 1960-1983]

      To determine long-term survival at least 35 years after surgical myectomy at NIH. To examine survival data in those subjects in whom we can confirm a date of death or an indication that they are still alive.

    Secondary Outcome Measures

    1. Cause of Death [End of Study]

      To determine cause of death

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • ELIGIBILITY:

    Patients operated on 1960-1983 with surgical myectomy by Dr. Andrew G. Morrow at the NIH.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Heart, Lung and Blood Institute (NHLBI) Bethesda Maryland United States 20892

    Sponsors and Collaborators

    • National Heart, Lung, and Blood Institute (NHLBI)

    Investigators

    • Principal Investigator: Douglas R Rosing, M.D., National Heart, Lung, and Blood Institute (NHLBI)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    National Heart, Lung, and Blood Institute (NHLBI)
    ClinicalTrials.gov Identifier:
    NCT04603521
    Other Study ID Numbers:
    • 10000093
    • 000093-H
    First Posted:
    Oct 27, 2020
    Last Update Posted:
    Jun 1, 2022
    Last Verified:
    May 1, 2022
    Keywords provided by National Heart, Lung, and Blood Institute (NHLBI)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 1, 2022