Hypertrophic Cardiomyopathy (HCM)NCT06683872
Evaluation of Clinical Efficacy and Prognosis in Patients With Hypertrophic Obstructive Cardiomyopathy Through Hemodynamic Modeling Reconstructed by CT
An observational study of Hypertrophic Cardiomyopathy (HCM), run by Zhejiang Provincial People's Hospital at 1 site in China.
Trial summary
Hypertrophic cardiomyopathy (HCM) is a common autosomal dominant inherited heart disease, with previous data suggesting a prevalence of approximately 1 in 500 in the population. However, with the widespread use of genetic testing and high-sensitivity cardiac imaging in recent years, the estimated prevalence of HCM may… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertrophic Cardiomyopathy (HCM)
- What is being tested?
- surgical myectomy
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 31 Aug 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patient diagnosed with hypertrophic cardiomyopathy comes from the Zhejiang Province People\'s Hospital, the First Affiliated Hospital of Shanghai Jiaotong University School of Medicine, and the Second Affiliated Hospital of Nanchang University.
Who may be able to join
- 1. Age: 18-70 years old 2. Maximum interventricular septum thickness ≥15mm 3. Dynamic left ventricular outflow tract gradient at rest or with provocation (Valsalva maneuver or exercise) ≥50mmHg 4. New York Heart Association (NYHA) functional classification ≥II 5. Presence of severe symptoms despite maximal medical therapy (maximal medical therapy for HCM may include combination of disopyramide and/or β-blockers and calcium channel blockers)
Who cannot join
- 1. Combined with other heart diseases that require surgical treatment, such as heart valve disease or coronary artery atherosclerotic heart disease.
- 2. Left ventricular ejection fraction \<40%. 3. Presence of the following arrhythmias: atrial fibrillation, QT interval \> 500ms, occurrence of sustained ventricular tachycardia in the past 6 months before screening.
- 4. Allergy to iodine contrast agents.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Hypertrophic cardiomyopathy (HCM) is a common autosomal dominant inherited heart disease, with previous data suggesting a prevalence of approximately 1 in 500 in the population. However, with the widespread use of genetic testing and high-sensitivity cardiac imaging in recent years, the estimated prevalence of HCM may be as high as 1 in 200. Approximately 75% of HCM patients will develop left ventricular outflow tract obstruction (LVOTO), leading to decreased exercise capacity, dyspnea, syncope, heart failure, and even sudden death, significantly impacting the patients\' quality of life and survival.
The optimal treatment for hypertrophic obstructive cardiomyopathy (HOCM) is still a matter of controversy, despite surgical myectomy being considered the \"gold standard\" for HOCM treatment. Treatment options such as chemical (radiofrequency) ablation and medications (Mavacamten) are also challenging the status, and there is even debate over the surgical approach for myectomy. Currently, there is no consensus in the medical community about the pathophysiological mechanisms of LVOTO, and the exact mechanisms of its occurrence are not fully understood, which is also a major reason for the treatment controversy in HOCM patients.
Read more
The focus of clinical decision-making is on the treatment based on the LVOTO pressure gradient, and it is generally recommended internationally to consider invasive treatment when the LVOTO pressure gradient is ≥50mmHg. However, there are still a small number of patients who do not have symptoms with a pressure gradient greater than 50mmHg or have significant symptoms with a pressure gradient less than 50mmHg, indicating that relying solely on the pressure gradient to assess the severity of HOCM and its prognosis may not be comprehensive enough.
In recent years, with the development of medical engineering integration, the use of computational fluid dynamics (CFD) in the medical field, particularly in the field of cardiovascular diseases, has become increasingly widespread. CFD can construct cardiovascular geometric models based on specific clinical images of a patient and simulate ventricular wall motion and blood flow within the heart through computer calculations to obtain the required hemodynamic parameters. This enables the visualization and quantification of intraventricular blood flow. Compared to direct measurement techniques based on imaging, CFD has advantages such as non-invasiveness, comprehensiveness, and accuracy, leading to its increasing application in cardiovascular function research. In particular, in the field of cardiomyopathy, CFD can help deepen the understanding of the pathophysiological mechanisms of hypertrophic obstructive cardiomyopathy by reconstructing the anatomical configuration of the left ventricle and analyzing intraventricular blood flow and related hemodynamic parameters, which in turn can aid in clinical decision-making and the assessment of clinical prognosis. Therefore, we propose using three-dimensional (3D) computed tomography (CT) simulation technology to assess the hemodynamics of patients with hypertrophic obstructive cardiomyopathy, in order to guide clinical decision-making.
- Conditions
- Hypertrophic Cardiomyopathy (HCM)
- Being tested
- surgical myectomy
- Keywords
- Hypertrophic cardiomyopathy, computational fluid dynamics
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical myectomyProcedure or surgery
Our procedure was performed via a right infra-axillary incision (4-5 cm), enter the thoracic cavity through the third intercostal space lateral to the pectoralis major muscle. Generally, neither rib resection nor division of the pectoralis major muscle were required. The intervention utilized femoral-femoral cardiopulmonary bypass (CPB). The aorta was clamped using a Glauber clamp (CardioVision MICAortic Clamp, Cardiomedical GmbH). Myocardial protection was achieved with antegrade Del Nido cardioplegia. After inducing of cardiac asystole, a transverse incision was made in the aorta and the aorta incision was suspended to enhance visualization. A mesh retractor (FEHLING INSTRUMENTS, Karlstein, Germany) was placed in the aortic sinus to protect the aortic leaflets. The extent of the septal myectomy, determined based on preoperative TEE, started 5 mm below the midpoint of the right coronary cusp. It extended counterclockwise towards the anterior commissure of the mitral valve a
| Study group | Role | What they receive |
|---|---|---|
| Patients with hypertrophic cardiomyopathy undergoing septal reduction therapy. | Not described Receives: Procedure: surgical myectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in left ventricular outflow tract pressure immediately after surgery and at 1 year postoperatively
Measured: From operation to one year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Aug 2024
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertrophic Cardiomyopathy (HCM)Studies of the same condition, open and under way.
- 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
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683872
- Sponsor's protocol ID
- KY2024113
- Status last verified
- Nov 2024
- First submitted
- 8 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Houston BA, Stevens GR. Hypertrophic cardiomyopathy: a review. Clin Med Insights Cardiol. 2015 Jan 26;8(Suppl 1):53-65. doi: 10.4137/CMC.S15717. eCollection 2014.
PubMed 25657602
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Efficacy and Prognosis in Patients With Hypertrophic Obstructive Cardiomyopathy Through Hemodynamic Modeling Reconstructed by CT
- ClinicalTrials.gov ID
- NCT06683872
- Acronym / sponsor ID
- KY2024113
- Conditions
- Hypertrophic Cardiomyopathy (HCM)
- Keywords
- Hypertrophic cardiomyopathy, computational fluid dynamics
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zhejiang Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 12 Nov 2024 (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.
Hypertrophic cardiomyopathy (HCM) is a common autosomal dominant inherited heart disease, with previous data suggesting a prevalence of approximately 1 in 500 in the population. However, with the widespread use of genetic testing and high-sensitivity cardiac imaging in recent years, the estimated prevalence of HCM may be as high as 1 in 200. Approximately 75% of HCM patients will develop left ventricular outflow tract obstruction (LVOTO), leading to decreased exercise capacity, dyspnea, syncope, heart failure, and even sudden death, significantly impacting the patients\' quality of life and survival.
The optimal treatment for hypertrophic obstructive cardiomyopathy (HOCM) is still a matter of controversy, despite surgical myectomy being considered the \"gold standard\" for HOCM treatment. Treatment options such as chemical (radiofrequency) ablation and medications (Mavacamten) are also challenging the status, and there is even debate over the surgical approach for myectomy. Currently, there is no consensus in the medical community about the pathophysiological mechanisms of LVOTO, and the exact mechanisms of its occurrence are not fully understood, which is also a major reason for the treatment controversy in HOCM patients.
The focus of clinical decision-making is on the treatment based on the LVOTO pressure gradient, and it is generally recommended internationally to consider invasive treatment when the LVOTO pressure gradient is ≥50mmHg. However, there are still a small number of patients who do not have symptoms with a pressure gradient greater than 50mmHg or have significant symptoms with a pressure gradient less than 50mmHg, indicating that relying solely on the pressure gradient to assess the severity of HOCM and its prognosis may not be comprehensive enough.
In recent years, with the development of medical engineering integration, the use of computational fluid dynamics (CFD) in the medical field, particularly in the field of cardiovascular diseases, has become increasingly widespread. CFD can construct cardiovascular geometric models based on specific clinical images of a patient and simulate ventricular wall motion and blood flow within the heart through computer calculations to obtain the required hemodynamic parameters. This enables the visualization and quantification of intraventricular blood flow. Compared to direct measurement techniques based on imaging, CFD has advantages such as non-invasiveness, comprehensiveness, and accuracy, leading to its increasing application in cardiovascular function research. In particular, in the field of cardiomyopathy, CFD can help deepen the understanding of the pathophysiological mechanisms of hypertrophic obstructive cardiomyopathy by reconstructing the anatomical configuration of the left ventricle and analyzing intraventricular blood flow and related hemodynamic parameters, which in turn can aid in clinical decision-making and the assessment of clinical prognosis. Therefore, we propose using three-dimensional (3D) computed tomography (CT) simulation technology to assess the hemodynamics of patients with hypertrophic obstructive cardiomyopathy, in order to guide clinical decision-making.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with hypertrophic cardiomyopathy undergoing septal reduction therapy. | – | Procedure: surgical myectomy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient diagnosed with hypertrophic cardiomyopathy comes from the Zhejiang Province People\'s Hospital, the First Affiliated Hospital of Shanghai Jiaotong University School of Medicine, and the Second Affiliated Hospital of Nanchang University.
Key inclusion criteria (1 listed)
- 1. Age: 18-70 years old 2. Maximum interventricular septum thickness ≥15mm 3. Dynamic left ventricular outflow tract gradient at rest or with provocation (Valsalva maneuver or exercise) ≥50mmHg 4. New York Heart Association (NYHA) functional classification ≥II 5. Presence of severe symptoms despite maximal medical therapy (maximal medical therapy for HCM may include combination of disopyramide and/or β-blockers and calcium channel blockers)
Key exclusion criteria (3 listed)
- 1. Combined with other heart diseases that require surgical treatment, such as heart valve disease or coronary artery atherosclerotic heart disease.
- 2. Left ventricular ejection fraction \<40%. 3. Presence of the following arrhythmias: atrial fibrillation, QT interval \> 500ms, occurrence of sustained ventricular tachycardia in the past 6 months before screening.
- 4. Allergy to iodine contrast agents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgical myectomyOur procedure was performed via a right infra-axillary incision (4-5 cm), enter the thoracic cavity through the third intercostal space lateral to the pectoralis major muscle. Generally, neither rib resection nor division of the pectoralis major muscle were required. The intervention utilized femoral-femoral cardiopulmonary bypass (CPB). The aorta was clamped using a Glauber clamp (CardioVision MICAortic Clamp, Cardiomedical GmbH). Myocardial protection was achieved with antegrade Del Nido cardioplegia. After inducing of cardiac asystole, a transverse incision was made in the aorta and the aorta incision was suspended to enhance visualization. A mesh retractor (FEHLING INSTRUMENTS, Karlstein, Germany) was placed in the aortic sinus to protect the aortic leaflets. The extent of the septal myectomy, determined based on preoperative TEE, started 5 mm below the midpoint of the right coronary cusp. It extended counterclockwise towards the anterior commissure of the mitral valve a | Procedure or surgery | Patients with hypertrophic cardiomyopathy undergoing septal reduction therapy. |
Primary outcome
Changes in left ventricular outflow tract pressure immediately after surgery and at 1 year postoperatively
Time frame: From operation to one year postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Results publication: PubMed 25657602Houston BA, Stevens GR. Hypertrophic cardiomyopathy: a review. Clin Med Insights Cardiol. 2015 Jan 26;8(Suppl 1):53-65. doi: 10.4137/CMC.S15717. eCollection 2014.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 (HCM), run by Zhejiang Provincial People's Hospital at 1 site in China.
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 1 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 12 Nov 2024. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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?
Changes in left ventricular outflow tract pressure immediately after surgery and at 1 year postoperatively (time frame: From operation to one year postoperatively). 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 NCT06683872, which also lists 1 linked publication.
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 12 Nov 2024.