Cardiomyopathy Clinical Trial
Official title:
Retrospective Study of Patients Long-Term Survival of Obstructive Hypertrophic Cardiomyopathy (HCM)
Verified date | May 2022 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | National Heart, Lung and Blood Institute (NHLBI) | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Heart, Lung, and Blood Institute (NHLBI) |
United States,
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
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 |
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