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

Cardiomyopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04603521
• Other study ID #: 10000093
• Secondary ID: 000093-H
• Status: Completed
• Start date: October 20, 2020
• Est. completion date: April 26, 2022

Study information

• Verified date: May 2022
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: April 26, 2022
• Est. primary completion date: March 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• ELIGIBILITY:

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy
• Cardiomyopathy, Hypertrophic
• Hypertrophy
• Obstructive Hypertrophic Cardiomyopathy

Locations

Country	Name	City	State
United States	National Heart, Lung and Blood Institute (NHLBI)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Dorobantu L, Ticulescu R, Greavu M, Dermengiu A, Alexandrescu M, Trofin M. Current management and surgical advances in patients with hypertrophic obstructive cardiomyopathy. Kardiol Pol. 2019 Sep 23;77(9):829-836. doi: 10.33963/KP.14965. Epub 2019 Sep 9. Review. — View Citation

Maron BJ, Ommen SR, Semsarian C, Spirito P, Olivotto I, Maron MS. Hypertrophic cardiomyopathy: present and future, with translation into contemporary cardiovascular medicine. J Am Coll Cardiol. 2014 Jul 8;64(1):83-99. doi: 10.1016/j.jacc.2014.05.003. Review. Erratum in: J Am Coll Cardiol. 2014 Sep 16;64(11):1188. — View Citation

Rastegar H, Boll G, Rowin EJ, Dolan N, Carroll C, Udelson JE, Wang W, Carpino P, Maron BJ, Maron MS, Chen FY. Results of surgical septal myectomy for obstructive hypertrophic cardiomyopathy: the Tufts experience. Ann Cardiothorac Surg. 2017 Jul;6(4):353-363. doi: 10.21037/acs.2017.07.07. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long term survival after surgical myectomy at NIH	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.	Enrolled NIH subjects 1960-1983
Secondary	Cause of Death	To determine cause of death	End of Study