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

NCT04603521 | Completed

• 2 other identifiers: 10000093000093-H
• Study Type: observational
• Target: 325
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiomyopathy; Obstructive Hypertrophic Cardiomyopathy

Keywords

HCM; Septal Myectomy; Surgical Intervention; Genetic Heart Disease; Natural History

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cause of Death

  End of Study

Study Arms (1)

Hypertrophic cardiomyopathy (HCM)

Survival after Myectomy Operation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

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

Study Sites (1)

National Heart, Lung and Blood Institute (NHLBI)

Bethesda, Maryland, 20892, United States

Location

Related 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.

  PMID: 31495825 BACKGROUND

• 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.

  PMID: 24998133 BACKGROUND

• 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.

  PMID: 28944176 BACKGROUND

MeSH Terms

Conditions

Cardiomyopathies; Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Douglas R Rosing, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2020
• First Posted: October 27, 2020
• Study Start: October 20, 2020
• Primary Completion: March 14, 2022
• Study Completion: April 26, 2022
• Last Updated: June 1, 2022

Record last verified: 2022-05

Locations

US (1)