Clinical trial NCT04603521: Patients' Long-Term Survival of Obstructive Hypertrophic Cardiomyopathy (HCM)
Official title: Retrospective Study of Patients Long-Term Survival of Obstructive Hypertrophic Cardiomyopathy (HCM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiomyopathy
Obstructive Hypertrophic Cardiomyopathy
Keywords: HCM
Septal Myectomy
Surgical Intervention
Genetic Heart Disease
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2020-10-27
Enrollment: 325
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients upon whom Dr. Andrew Morrow performed a surgical myectomy at the NIH between 1960 and 1983.

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.

Eligibility criteria: * ELIGIBILITY:

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

Primary outcomes:
measure: Long term survival after surgical myectomy at NIH
timeFrame: Enrolled NIH subjects 1960-1983
Secondary outcomes:
measure: Cause of Death
timeFrame: End of Study
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Heart, Lung and Blood Institute (NHLBI)
state: Maryland
Study officials:
affiliation: National Heart, Lung, and Blood Institute (NHLBI)
name: Douglas R Rosing, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.