Cardiomyopathy, Hypertrophic ObstructiveNCT06391788
Efficacy and Safety of Thoracoscopic Morrow Surgery in the Treatment of Hypertrophic Obstructive Cardiomyopathy
A study testing thoracoscopic Morrow surgery and modified Morrow surgery in people with Cardiomyopathy, Hypertrophic Obstructive and Minimally Invasive Surgery, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
This single-center, prospective, open-label, randomized, controlled clinical trial is designed to assess the efficacy and safety of the Thoracoscopic Morrow procedure in the treatment of hypertrophic obstructive cardiomyopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathy, Hypertrophic Obstructive, Minimally Invasive Surgery
- What is being tested?
- thoracoscopic Morrow surgery and modified Morrow surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2023to 31 Mar 2025
- Phase
- Interventional
- 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
Who may be able to join
- diagnosed with hypertrophic cardiomyopathy (HCM);
- age ≥18 years old;
- presence of left ventricular outflow tract/mid-ventricular obstruction, with a resting left ventricular outflow tract pressure gradient/left ventricular cavity pressure gradient ≥50 mmHg; significant symptoms persist despite optimal medical therapy, and surgical evaluation indicates the need for intervention;
- left ventricular ejection fraction (LVEF) ≥55%;
- signed informed consent, willing and able to return to the hospital for follow-up.
Who cannot join
- previously underwent septal reduction therapy (including surgical or interventional procedures);
- received or planning to receive an implantable cardioverter-defibrillator (ICD) in the past 3 months;
- individuals with concomitant conditions requiring simultaneous surgical intervention;
- New York Heart Association (NYHA) functional class IV;
- unwilling to undergo surgical treatment;
- pregnant or lactating or planning pregnancy;
- previously participated in other clinical trials before enrollment;
- individuals with concurrent diseases with an expected lifespan of less than 1 year.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital, National Centre for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing
Xin Wang, 13901036490, fuwaiwangxin@188.com
Lei Song, 13810532620, songlqd@126.com
About this study
Official title: Efficacy and Safety of Thoracoscopic Morrow Surgery in the Treatment of Hypertrophic Obstructive Cardiomyopathy: a Single-center, Prospective, Open-label, Randomized, Controlled Trial
This single-center, prospective, open-label, randomized, controlled clinical trial is designed to assess the efficacy and safety of the Thoracoscopic Morrow procedure in the treatment of hypertrophic obstructive cardiomyopathy. The primary objectives include investigating:
Question 1: The efficacy and safety of two surgical modalities in patients presenting with left ventricular outflow tract obstruction and mid-left ventricular hypertrophy.
Read more
Question 2: The impact of the two surgical procedures on hemodynamics in patients with left ventricular outflow tract obstruction, mid-left ventricular obstruction, and in individuals with or without organic valvular lesions.
Question 3: The effects of the two surgical procedures on exercise capacity, quality of life, and long-term prognosis among patients with left ventricular outflow tract obstruction and central left ventricular obstruction, both with and without valvular lesions.
Participants will be stratified into two groups. The experimental group will undergo thoracoscopic Morrow surgery, while the control group will undergo median open modified enlarged Morrow surgery.
Read the detailed description
This study is a single-center, prospective, open-label, randomized, controlled trial designed to investigate the therapeutic value of thoracoscopic Morrow procedure in patients with hypertrophic obstructive cardiomyopathy (HOCM). The study focuses on HOCM patients, with the modified extended Morrow procedure via median sternotomy considered as the 'gold standard treatment' in the control group. The objective is to explore the efficacy of the thoracoscopic Morrow procedure in improving exercise tolerance in HOCM patients, assess the short-term and long-term effectiveness, safety, as well as changes in cardiac function, cardiac structure, and myocardial fibrosis levels associated with thoracoscopic Morrow procedure in treating obstructive HOCM.
- Being tested
- thoracoscopic Morrow surgery, modified Morrow surgery
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracoscopic Morrow surgeryProcedure or surgery
minimally invasive trans-mitral Morrow septal myectomy
modified Morrow surgeryProcedure or surgery
median open modified enlarged Morrow septal myectomy
| Study group | Role | What they receive |
|---|---|---|
| Thoracoscopic trans-mitral myectomy | Experimental | patients who undergo thoracoscopic Morrow procedure Receives: Procedure: thoracoscopic Morrow surgery |
| Modified extended Morrow myectomy | Active comparator | patients who undergo modified extended Morrow myectomy Receives: Procedure: modified Morrow surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular outflow tract gradient variability
Change in Left ventricular outflow tract gradient pre- and post- intervention
Measured: 6 months,9 months and 12 months
Secondary outcomes (6)
6-minute walk distance
A measure used to assess the functional exercise capacity of individuals. It is determined by the distance a person can walk in 6 minutes on a flat, hard surface.
Measured: 6 months,9 months and 12 months
New York Heart Association Functional Classification of Heart Failure
A system used to categorize the severity of heart failure based on the functional limitations of individuals.
Measured: 6 months,9 months and 12 months
Marker of myocardial injury
To assay the concentration of proteins(cardiac troponin T, cardiac troponin I)associated with myocardial injury.
Measured: 6 months,9 months and 12 months
Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score
A disease-specific health status measure designed to assess the impact of heart failure on patients' quality of life.
Measured: 6 months,9 months and 12 months
Echocardiographic indicator
Left ventricular ejection fraction assessed by echocardiography.
Measured: 6 months,9 months and 12 months
Cardiac magnetic resonance indicator
The left ventricular mass index was assessed using cardiac magnetic resonance imaging.
Measured: 6 months,9 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start31 Mar 2023
- Primary completion1 Feb 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiomyopathy, Hypertrophic ObstructiveStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Xin Wang, Principal investigator, Fuwai Hospital, National Centre for Cardiovascular DiseaseLei Song, Principal investigator, Fuwai Hospital, National Centre for Cardiovascular Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391788
- Sponsor's protocol ID
- 2023-ZX013
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Thoracoscopic Morrow Surgery in the Treatment of Hypertrophic Obstructive Cardiomyopathy: a Single-center, Prospective, Open-label, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT06391788
- Acronym / sponsor ID
- 2023-ZX013
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 30 Apr 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.
This single-center, prospective, open-label, randomized, controlled clinical trial is designed to assess the efficacy and safety of the Thoracoscopic Morrow procedure in the treatment of hypertrophic obstructive cardiomyopathy. The primary objectives include investigating:
Question 1: The efficacy and safety of two surgical modalities in patients presenting with left ventricular outflow tract obstruction and mid-left ventricular hypertrophy.
Question 2: The impact of the two surgical procedures on hemodynamics in patients with left ventricular outflow tract obstruction, mid-left ventricular obstruction, and in individuals with or without organic valvular lesions.
Question 3: The effects of the two surgical procedures on exercise capacity, quality of life, and long-term prognosis among patients with left ventricular outflow tract obstruction and central left ventricular obstruction, both with and without valvular lesions.
Participants will be stratified into two groups. The experimental group will undergo thoracoscopic Morrow surgery, while the control group will undergo median open modified enlarged Morrow surgery.
Detailed description
This study is a single-center, prospective, open-label, randomized, controlled trial designed to investigate the therapeutic value of thoracoscopic Morrow procedure in patients with hypertrophic obstructive cardiomyopathy (HOCM). The study focuses on HOCM patients, with the modified extended Morrow procedure via median sternotomy considered as the 'gold standard treatment' in the control group. The objective is to explore the efficacy of the thoracoscopic Morrow procedure in improving exercise tolerance in HOCM patients, assess the short-term and long-term effectiveness, safety, as well as changes in cardiac function, cardiac structure, and myocardial fibrosis levels associated with thoracoscopic Morrow procedure in treating obstructive HOCM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracoscopic trans-mitral myectomy | Experimental | Procedure: thoracoscopic Morrow surgerypatients who undergo thoracoscopic Morrow procedure |
| Modified extended Morrow myectomy | Active comparator | Procedure: modified Morrow surgerypatients who undergo modified extended Morrow myectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- diagnosed with hypertrophic cardiomyopathy (HCM);
- age ≥18 years old;
- presence of left ventricular outflow tract/mid-ventricular obstruction, with a resting left ventricular outflow tract pressure gradient/left ventricular cavity pressure gradient ≥50 mmHg; significant symptoms persist despite optimal medical therapy, and surgical evaluation indicates the need for intervention;
- left ventricular ejection fraction (LVEF) ≥55%;
- signed informed consent, willing and able to return to the hospital for follow-up.
Key exclusion criteria (8 listed)
- previously underwent septal reduction therapy (including surgical or interventional procedures);
- received or planning to receive an implantable cardioverter-defibrillator (ICD) in the past 3 months;
- individuals with concomitant conditions requiring simultaneous surgical intervention;
- New York Heart Association (NYHA) functional class IV;
- unwilling to undergo surgical treatment;
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 |
|---|---|---|
| thoracoscopic Morrow surgeryminimally invasive trans-mitral Morrow septal myectomy | Procedure or surgery | Thoracoscopic trans-mitral myectomy |
| modified Morrow surgerymedian open modified enlarged Morrow septal myectomy | Procedure or surgery | Modified extended Morrow myectomy |
Primary outcome
Left ventricular outflow tract gradient variability
Time frame: 6 months,9 months and 12 months
Change in Left ventricular outflow tract gradient pre- and post- intervention
6 secondary outcomes
6-minute walk distance
Time frame: 6 months,9 months and 12 months
New York Heart Association Functional Classification of Heart Failure
Time frame: 6 months,9 months and 12 months
Marker of myocardial injury
Time frame: 6 months,9 months and 12 months
Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score
Time frame: 6 months,9 months and 12 months
Echocardiographic indicator
Time frame: 6 months,9 months and 12 months
Cardiac magnetic resonance indicator
Time frame: 6 months,9 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- 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.
Xin Wang principal investigator
Fuwai Hospital, National Centre for Cardiovascular Disease
Lei Song principal investigator
Fuwai Hospital, National Centre for Cardiovascular Disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thoracoscopic Morrow surgery and modified Morrow surgery in people with Cardiomyopathy, Hypertrophic Obstructive and Minimally Invasive Surgery, run by China National Center for Cardiovascular Diseases 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 5 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: status not confirmed, as of the sponsor's last update on 30 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin Wang (13901036490, fuwaiwangxin@188.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular outflow tract gradient variability (time frame: 6 months,9 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2024.