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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.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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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.

China1 site
  • Zhejiang Province People's Hospital

    Hangzhou, Zhejiang, 310014

Other trials in China

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.

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 groups in NCT06683872
Study groupRoleWhat 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.

  1. 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.

  1. First posted12 Nov 2024
  2. Study start1 Aug 2024
  3. Primary completion31 Aug 2025 (estimated)
  4. Study completion31 Aug 2026 (estimated)

Resources

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
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

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.

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