Hypertrophic CardiomyopathySPIRIT-HCMNCT03092843
Functional Capacity and Quality of Life Following Septal Myectomy in Patients With HCM
An observational study of Hypertrophic Cardiomyopathy, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Investigators aim to assess changes in exercise capacity and quality of life after septal myectomy in patient with hypertrophic cardiomyopathy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- How many people
- 177 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2017to 30 Mar 2023
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18-65 with an established diagnosis of obstructive hypertrophic cardiomyopathy and scheduled for septal Myectomy surgery
Who may be able to join
- Scheduled to undergo septal myectomy.
- Established diagnosis of obstructive HCM defined as:
- LVH Thickness ≥15mm left ventricular outflow tract gradient ≥50mmHg
Who cannot join
- Prior septal myectomy or alcohol septal ablation
- Prior myocardial infarction
- Uncontrolled arrhythmias including ventricular tachycardia and atrial fibrillation
- Uncontrolled hypertension
- Angiographically documented coronary stenosis >50%, if available at time of screening
- Inability to provide informed consent
- Inability to walk without assistive devices
- Peripheral artery disease with claudication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Capacity and Quality of Life Following SePtal Myectomy in patIents With Obstructive hypeRtrophIc cardiomyopaThy
Investigators aim to assess changes in exercise capacity and quality of life after septal myectomy in patient with hypertrophic cardiomyopathy.
Read the detailed description
The objective of this study is to examine change in quality of life and functional capacity as respectively measured by, Quality of Life Questionnaires and six-minute walk test distance, following septal myectomy in patients with obstructive hypertrophic cardiomyopathy, as compared to prior to surgery.
- Conditions
- Hypertrophic Cardiomyopathy
- Medical subject headings
- 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 |
|---|---|---|
| No functional capacity testing | 6 minute walk Quality of life Questionaire | |
| Functional Capacity Testing | 6 minute walk Quality of Life Questionnaire Metabolic stress test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life Change in Summary Score
Mild improvement in Quality of Life summary score (increase in 5 points) as measured by Kansas City Cardiomyopathy Questionnaire -KCCQ
Measured: 1 year post myectomy
Secondary outcomes (3)
Change in Quality of Life Change in Patient Reported Outcomes
Quality of Life as measured by The Patient-Reported Outcomes Measurement Information System (PROMIS) Questionnaire
Measured: 1 year post myectomy
Change in Quality of Life Change in Duke's Activity Status Index (DASI)
Quality of Life as measured by the Duke's Activity Status Index (DASI) Questionnaire
Measured: 1 year post myectomy
Change in functional capacity post myectomy
Functional capacity will be measured by 6 minute walk
Measured: 1 year post myectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start20 Mar 2017
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Prospective
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Milind Desai, The Cleveland Clinic
- Investigators
- Milind Desai, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03092843
- Sponsor's protocol ID
- 17-176
- Acronym
- SPIRIT-HCM
- Status last verified
- Aug 2023
- First submitted
- 22 Mar 2017
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Desai MY, Szpakowski N, Tower-Rader A, Bittel B, Fava A, Ospina S, Xu B, Thamilarasan M, Mentias A, Smedira NG, Popovic ZB. Echocardiographic Changes Following Surgical Myectomy in Severely Symptomatic Obstructive Hypertrophic Cardiomyopathy: Insights From the SPIRIT-HCM Study. J Am Heart Assoc. 2025 Jan 7;14(1):e037058. doi: 10.1161/JAHA.124.037058. Epub 2024 Dec 24.
PubMed 39719417Tower-Rader A, Szpakowski N, Popovic ZB, Bittel B, Fava A, Ospina S, Xu B, Thamilarasan M, Mentias A, Smedira NG, Desai MY. Patient reported outcomes in obstructive hypertrophic cardiomyopathy undergoing myectomy: Results from SPIRIT-HCM study. Prog Cardiovasc Dis. 2023 Sep-Oct;80:66-73. doi: 10.1016/j.pcad.2023.06.001. Epub 2023 Jun 9.
PubMed 37302651
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Capacity and Quality of Life Following SePtal Myectomy in patIents With Obstructive hypeRtrophIc cardiomyopaThy
- ClinicalTrials.gov ID
- NCT03092843
- Acronym / sponsor ID
- SPIRIT-HCM / 17-176
- Conditions
- Hypertrophic Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 28 Mar 2017 (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.
Investigators aim to assess changes in exercise capacity and quality of life after septal myectomy in patient with hypertrophic cardiomyopathy.
Detailed description
The objective of this study is to examine change in quality of life and functional capacity as respectively measured by, Quality of Life Questionnaires and six-minute walk test distance, following septal myectomy in patients with obstructive hypertrophic cardiomyopathy, as compared to prior to surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No functional capacity testing | – | –6 minute walk Quality of life Questionaire |
| Functional Capacity Testing | – | –6 minute walk Quality of Life Questionnaire Metabolic stress test |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-65 with an established diagnosis of obstructive hypertrophic cardiomyopathy and scheduled for septal Myectomy surgery
Key inclusion criteria (3 listed)
- Scheduled to undergo septal myectomy.
- Established diagnosis of obstructive HCM defined as:
- LVH Thickness ≥15mm left ventricular outflow tract gradient ≥50mmHg
Key exclusion criteria (8 listed)
- Prior septal myectomy or alcohol septal ablation
- Prior myocardial infarction
- Uncontrolled arrhythmias including ventricular tachycardia and atrial fibrillation
- Uncontrolled hypertension
- Angiographically documented coronary stenosis >50%, if available at time of screening
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
Change in Quality of Life Change in Summary Score
Time frame: 1 year post myectomy
Mild improvement in Quality of Life summary score (increase in 5 points) as measured by Kansas City Cardiomyopathy Questionnaire -KCCQ
3 secondary outcomes
Change in Quality of Life Change in Patient Reported Outcomes
Time frame: 1 year post myectomy
Change in Quality of Life Change in Duke's Activity Status Index (DASI)
Time frame: 1 year post myectomy
Change in functional capacity post myectomy
Time frame: 1 year post myectomy
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 7 Aug 2023.
- Derived from this study: PubMed 39719417Desai MY, Szpakowski N, Tower-Rader A, Bittel B, Fava A, Ospina S, Xu B, Thamilarasan M, Mentias A, Smedira NG, Popovic ZB. Echocardiographic Changes Following Surgical Myectomy in Severely Symptomatic Obstructive Hypertrophic Cardiomyopathy: Insights From the SPIRIT-HCM Study. J Am Heart Assoc. 2025 Jan 7;14(1):e037058. doi: 10.1161/JAHA.124.037058. Epub 2024 Dec 24.
- Derived from this study: PubMed 37302651Tower-Rader A, Szpakowski N, Popovic ZB, Bittel B, Fava A, Ospina S, Xu B, Thamilarasan M, Mentias A, Smedira NG, Desai MY. Patient reported outcomes in obstructive hypertrophic cardiomyopathy undergoing myectomy: Results from SPIRIT-HCM study. Prog Cardiovasc Dis. 2023 Sep-Oct;80:66-73. doi: 10.1016/j.pcad.2023.06.001. Epub 2023 Jun 9.
- Individual participant dataSharing planned: No
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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.
Milind Desai, MD principal investigator
The Cleveland Clinic
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 Hypertrophic Cardiomyopathy, run by The Cleveland Clinic 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?
The sponsor lists 3 inclusion and 8 exclusion criteria. 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 7 Aug 2023. 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?
Change in Quality of Life Change in Summary Score (time frame: 1 year post myectomy). 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 NCT03092843, which also lists 2 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 7 Aug 2023.