HCMNCT07483125
Valsalva SBP Drop and LVOT Obstruction
An observational study of HCM and oHCM, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This study aimed to evaluate the efficacy of non-invasive dynamic blood pressure monitoring in assessing left ventricular outflow tract obstruction in patients with hypertrophic cardiomyopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- participants are not assigned an intervention as part of the study
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HCM patients: In this study, transthoracic echocardiography (TTE) was used as the gold standard. Left ventricular outflow tract obstruction (LVOTO) was defined as a resting left ventricular outflow tract gradient (LVOTG) ≥ 30 mmHg, or an LVOTG ≥ 50 mmHg after provocation tests (e.g., Valsalva maneuver), according
Who may be able to join
- 2: ② Diagnosed with hypertrophic cardiomyopathy (HCM) by echocardiography, with or without left ventricular outflow tract obstruction
- 3: ③ Conscious and mentally competent, able to understand and voluntarily sign the informed consent form
- 4: ④ Able to cooperate with the completion of provocation tests, non-invasive dynamic hemodynamic monitoring, and relevant follow-up examinations.
- -
Who cannot join
- 1: ① Age ≤ 18 years, or pregnant/lactating patients
- 2: ② Presence of other organic heart or great vessel diseases that cause left ventricular outflow tract obstruction, such as severe aortic stenosis, congenital subaortic membrane, etc.
- 3: ③ Complicated with persistent atrial fibrillation or other severe arrhythmias that may affect the accuracy of hemodynamic monitoring
- 4: ④ Previous history of interventional or surgical therapy for left ventricular outflow tract obstruction, including septal ablation or myectomy
- 5: ⑤ Patients with other conditions considered inappropriate by the investigators (e.g., those with absolute or relative contraindications to provocation tests)
- 6: ⑥ Patients currently participating in other clinical studies.
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, 1 recruiting
- Recruiting
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Yixiu Liang, PhD, +86 13566781221, liang.yixiu@zs-hospital.sh.cn
About this study
Official title: Safety and Efficacy of Non-invasive and Ambulatory Hemodynamic Monitoring for Evaluating the Left Ventricular Outflow Tract Obstruction in Hypertrophic Cardiomyopathy
This study aimed to evaluate the efficacy of non-invasive dynamic blood pressure monitoring in assessing left ventricular outflow tract obstruction in patients with hypertrophic cardiomyopathy. We prospectively collected SBP waveforms and LVOT gradient data from patients with obstructive and non-obstructive disease, systematically analyzed their correlation, and explored its clinical value in different clinical scenarios.
Read the detailed description
Research Background
Left ventricular outflow tract obstruction (LVOTO) is a common pathophysiological change in various cardiac diseases (e.g., hypertrophic obstructive cardiomyopathy, aortic stenosis, etc.). It impedes cardiac ejection and severely affects patient prognosis.Currently, the measurement of LVOTG ≥ 30 mmHg by echocardiography is the gold standard in clinical practice for evaluating the diagnostic value of SBP waveform typing for LVOTO. However, this method is complex to operate, relies on physician experience, and does not allow continuous dynamic monitoring, which limits its application in long-term follow-up and timely adjustment of treatment regimens.Although arterial systolic blood pressure (SBP), as a key hemodynamic indicator, may be associated with the severity of LVOTO (i.e., left ventricular outflow tract gradient, LVOTG), the specific relationship, dynamic change pattern, and clinical applicability between them remain unclear.
Research Objectives
This study aims to evaluate the effectiveness of non-invasive dynamic blood flow monitoring techniques in assessing left ventricular outflow tract obstruction in patients with hypertrophic cardiomyopathy. By prospectively collecting SBP waveform and LVOTG data from patients with obstructive and non-obstructive conditions, we will systematically analyze their correlation and explore their application value in different clinical scenarios.
Study Endpoints
Primary Endpoints
① Correlation coefficient between SBP waveform characteristics and measured LVOTG values;② Sensitivity and specificity of SBP waveforms in differentiating obstructive HCM with left ventricular outflow tract obstruction.
Secondary Endpoints
① Differences in SBP waveform parameters (e.g., waveform peak, waveform duration, etc.) between obstructive and non-obstructive groups;② Consistency between SBP waveform typing and results of traditional clinical imaging methods (e.g., echocardiography);③ Incidence of procedure-related adverse events.
Study Design
This is a prospective, single-center, observational, parallel-controlled study. SBP waveform and LVOTG data will be prospectively collected from obstructive and non-obstructive patients to systematically analyze their correlation.
Gold Standard
Transthoracic echocardiography (TTE) is used as the gold standard in this study.LVOTO is defined as a resting left ventricular outflow tract peak gradient (LVOTG) ≥ 30 mmHg, or an LVOTG ≥ 50 mmHg after provocation testing (e.g., Valsalva maneuver), according to the 2020 ASE guidelines.
- Being tested
- participants are not assigned an intervention as part of the study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
participants are not assigned an intervention as part of the studyOther
participants are not assigned an intervention as part of the study
| Study group | Role | What they receive |
|---|---|---|
| HCM | HCM patients Receives: Other: participants are not assigned an intervention as part of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of SBP waveform in differentiating obstructive HCM caused by left ventricular outflow tract obstruction
Sensitivity and specificity of SBP waveform in differentiating obstructive HCM caused by left ventricular outflow tract obstruction
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start1 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCMStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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
- 800 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483125
- Sponsor's protocol ID
- KY2026042
- Other IDs
- Ziqing Yu
- Status last verified
- Mar 2026
- First submitted
- 15 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- 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 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Non-invasive and Ambulatory Hemodynamic Monitoring for Evaluating the Left Ventricular Outflow Tract Obstruction in Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT07483125
- Acronym / sponsor ID
- KY2026042
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Mar 2026 (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 study aimed to evaluate the efficacy of non-invasive dynamic blood pressure monitoring in assessing left ventricular outflow tract obstruction in patients with hypertrophic cardiomyopathy. We prospectively collected SBP waveforms and LVOT gradient data from patients with obstructive and non-obstructive disease, systematically analyzed their correlation, and explored its clinical value in different clinical scenarios.
Detailed description
Research Background
Left ventricular outflow tract obstruction (LVOTO) is a common pathophysiological change in various cardiac diseases (e.g., hypertrophic obstructive cardiomyopathy, aortic stenosis, etc.). It impedes cardiac ejection and severely affects patient prognosis.Currently, the measurement of LVOTG ≥ 30 mmHg by echocardiography is the gold standard in clinical practice for evaluating the diagnostic value of SBP waveform typing for LVOTO. However, this method is complex to operate, relies on physician experience, and does not allow continuous dynamic monitoring, which limits its application in long-term follow-up and timely adjustment of treatment regimens.Although arterial systolic blood pressure (SBP), as a key hemodynamic indicator, may be associated with the severity of LVOTO (i.e., left ventricular outflow tract gradient, LVOTG), the specific relationship, dynamic change pattern, and clinical applicability between them remain unclear.
Research Objectives
This study aims to evaluate the effectiveness of non-invasive dynamic blood flow monitoring techniques in assessing left ventricular outflow tract obstruction in patients with hypertrophic cardiomyopathy. By prospectively collecting SBP waveform and LVOTG data from patients with obstructive and non-obstructive conditions, we will systematically analyze their correlation and explore their application value in different clinical scenarios.
Study Endpoints
Primary Endpoints
① Correlation coefficient between SBP waveform characteristics and measured LVOTG values;② Sensitivity and specificity of SBP waveforms in differentiating obstructive HCM with left ventricular outflow tract obstruction.
Secondary Endpoints
① Differences in SBP waveform parameters (e.g., waveform peak, waveform duration, etc.) between obstructive and non-obstructive groups;② Consistency between SBP waveform typing and results of traditional clinical imaging methods (e.g., echocardiography);③ Incidence of procedure-related adverse events.
Study Design
This is a prospective, single-center, observational, parallel-controlled study. SBP waveform and LVOTG data will be prospectively collected from obstructive and non-obstructive patients to systematically analyze their correlation.
Gold Standard
Transthoracic echocardiography (TTE) is used as the gold standard in this study.LVOTO is defined as a resting left ventricular outflow tract peak gradient (LVOTG) ≥ 30 mmHg, or an LVOTG ≥ 50 mmHg after provocation testing (e.g., Valsalva maneuver), according to the 2020 ASE guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCM | – | Other: participants are not assigned an intervention as part of the studyHCM patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HCM patients: In this study, transthoracic echocardiography (TTE) was used as the gold standard. Left ventricular outflow tract obstruction (LVOTO) was defined as a resting left ventricular outflow tract gradient (LVOTG) ≥ 30 mmHg, or an LVOTG ≥ 50 mmHg after provocation tests (e.g., Valsalva maneuver), according
Key inclusion criteria (4 listed)
- 2: ② Diagnosed with hypertrophic cardiomyopathy (HCM) by echocardiography, with or without left ventricular outflow tract obstruction
- 3: ③ Conscious and mentally competent, able to understand and voluntarily sign the informed consent form
- 4: ④ Able to cooperate with the completion of provocation tests, non-invasive dynamic hemodynamic monitoring, and relevant follow-up examinations.
- -
Key exclusion criteria (6 listed)
- 1: ① Age ≤ 18 years, or pregnant/lactating patients
- 2: ② Presence of other organic heart or great vessel diseases that cause left ventricular outflow tract obstruction, such as severe aortic stenosis, congenital subaortic membrane, etc.
- 3: ③ Complicated with persistent atrial fibrillation or other severe arrhythmias that may affect the accuracy of hemodynamic monitoring
- 4: ④ Previous history of interventional or surgical therapy for left ventricular outflow tract obstruction, including septal ablation or myectomy
- 5: ⑤ Patients with other conditions considered inappropriate by the investigators (e.g., those with absolute or relative contraindications to provocation tests)
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 |
|---|---|---|
| participants are not assigned an intervention as part of the studyparticipants are not assigned an intervention as part of the study | Other | HCM |
Primary outcome
Sensitivity and specificity of SBP waveform in differentiating obstructive HCM caused by left ventricular outflow tract obstruction
Time frame: 1 year
Sensitivity and specificity of SBP waveform in differentiating obstructive HCM caused by left ventricular outflow tract obstruction
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 19 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for HCM
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Recruiting
Positron Emission Tomography to Assess the Effect of Camzyos on Ischaemia in HOCM: PEACH Trial
Hypertrophic Obstructive Cardiomyopathy \(HOCM\), Left Ventricular Outflow Tract Obstruction
RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Coronary Artery Disease, Myocarditis
RecruitingPhase 1
Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HTX-001
Nonobstructive Hypertrophic Cardiomyopathy
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.
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 HCM and oHCM, run by Shanghai Zhongshan 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 19 Mar 2026. 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?
Contact Ziqing Yu, PhD (+86 18833221133, yu.ziqing@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of SBP waveform in differentiating obstructive HCM caused by left ventricular outflow tract obstruction (time frame: 1 year). 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 19 Mar 2026.