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CompletedNCT04603521Updated Jun 1, 2022

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

An observational study in Cardiomyopathy and Obstructive Hypertrophic Cardiomyopathy, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-01.

Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
325
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Cardiomyopathy
  • Obstructive Hypertrophic Cardiomyopathy

Keywords

  • HCM
  • Septal Myectomy
  • Surgical Intervention
  • Genetic Heart Disease
  • Natural History
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In context

Cardiomyopathies

1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.

This study's enrollment of 325 is above the median of 153 across 515 observational studies indexed under Cardiomyopathies.

Browse Cardiomyopathies studies →

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,117 studies on the registry; 71 are open to participants now.

Of its 57 completed or terminated interventional studies of FDA-regulated products, 49 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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 criteria

  • ELIGIBILITY:

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

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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
325 participants (actual)

Groups and cohorts

  • Hypertrophic cardiomyopathy (HCM)

    Survival after Myectomy Operation

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What researchers measure

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.

    Time frame: Enrolled NIH subjects 1960-1983

Secondary outcomes

  1. Cause of Death

    To determine cause of death

    Time frame: End of Study

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Study locations

1 site
  • National Heart, Lung and Blood Institute (NHLBI)
    Bethesda, Maryland 20892, United States
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References and documents

Publications

  • 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. PubMed 31495825 ↗
  • 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. Erratum In: J Am Coll Cardiol. 2014 Sep 16;64(11):1188. PubMed 24998133 ↗
  • 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. PubMed 28944176 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04603521
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Sponsor
First posted
Oct 27, 2020
Start date
Oct 20, 2020
Primary completion
Mar 14, 2022
Completion
Apr 26, 2022
Last update
Jun 1, 2022

Study contacts

Douglas R Rosing, M.D.
principal investigator · National Heart, Lung, and Blood Institute (NHLBI)
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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