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

Completed

• Conditions: Cardiomyopathy; Obstructive Hypertrophic Cardiomyopathy

• Registration Number: NCT04603521
• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

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.

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 Timeline

• Study Start: 2020-10-20
• Study First Submitted: 2020-10-24
• Study First Submitted QC: 2020-10-24
• Study First Posted: 2020-10-27
• Primary Completion: 2022-03-14
• Study Completion: 2022-04-26
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-27
• Last Update Posted: 2022-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 325

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Cause of Death	End of Study	To determine cause of death

Trial Locations

Locations (1)

National Heart, Lung and Blood Institute (NHLBI); 🇺🇸 Bethesda, Maryland, United States