CardiomyopathyNCT04603521
Patients' Long-Term Survival of Obstructive Hypertrophic Cardiomyopathy (HCM)
An observational study of Cardiomyopathy and Obstructive Hypertrophic Cardiomyopathy, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathy, Obstructive Hypertrophic Cardiomyopathy
- How many people
- 325 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2020to 26 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, 20892
About this study
Official title: Retrospective Study of Patients Long-Term Survival of Obstructive Hypertrophic Cardiomyopathy (HCM)
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.
Read more
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.
- Keywords
- HCM, Septal Myectomy, Surgical Intervention, Genetic Heart Disease, Natural History
- Medical subject headings
- Cardiomyopathies, Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hypertrophic cardiomyopathy (HCM) | Survival after Myectomy Operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Enrolled NIH subjects 1960-1983
Secondary outcomes (1)
Cause of Death
To determine cause of death
Measured: End of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start20 Oct 2020
- Primary completion14 Mar 2022
- Study completion26 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CardiomyopathyStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Douglas R Rosing, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603521
- Sponsor's protocol ID
- 10000093
- Other IDs
- 000093-H
- Status last verified
- May 2022
- First submitted
- 24 Oct 2020
- Last updated
- 1 Jun 2022
- Results posted
- No
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 31495825Maron 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.
PubMed 24998133Rastegar 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Patients Long-Term Survival of Obstructive Hypertrophic Cardiomyopathy (HCM)
- ClinicalTrials.gov ID
- NCT04603521
- Acronym / sponsor ID
- 10000093
- Keywords
- HCM, Septal Myectomy, Surgical Intervention, Genetic Heart Disease, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 14 Mar 2022 (actual)
- Study completion
- 26 Apr 2022 (actual)
- First posted
- 27 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypertrophic cardiomyopathy (HCM) | – | –Survival after Myectomy Operation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients upon whom Dr. Andrew Morrow performed a surgical myectomy at the NIH between 1960 and 1983.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Long term survival after surgical myectomy at NIH
Time frame: Enrolled NIH subjects 1960-1983
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.
1 secondary outcome
Cause of Death
Time frame: End of Study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Background: PubMed 31495825Dorobantu 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.
- Background: PubMed 24998133Maron 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.
- Background: PubMed 28944176Rastegar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas R Rosing, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathy and Obstructive Hypertrophic Cardiomyopathy, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long term survival after surgical myectomy at NIH (time frame: Enrolled NIH subjects 1960-1983). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04603521, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022; AzTrials last refreshed its copy on 8 Nov 2026.