Valsalva blood pressure drop and obstruction of the heart's outflow tract
Official title: Safety and Efficacy of Non-invasive and Ambulatory Hemodynamic Monitoring for Evaluating the Left Ventricular Outflow Tract Obstruction in Hypertrophic Cardiomyopathy
Run by Shanghai Zhongshan Hospital · NCT07483125 · Data updated 2026-11-12
This project will test whether non-invasive blood pressure waveforms during Valsalva maneuvers can tell if adults with hypertrophic cardiomyopathy have left ventricular outflow tract obstruction.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 800 (estimated) |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | December 1, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | March 19, 2026 |
| Trial ID | NCT07483125 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with a diagnosis of hypertrophic cardiomyopathy who can perform provocation tests, are conscious and able to consent, and have not had prior septal reduction therapy are ideal candidates.
✕Probably not a fit
Patients under 18, pregnant or lactating individuals, those with other structural causes of LVOT obstruction (for example severe aortic stenosis), persistent atrial fibrillation, or prior septal myectomy/ablation are unlikely to benefit from this method.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers prospectively collected systolic blood pressure (SBP) waveforms and echocardiographic left ventricular outflow tract gradient (LVOTG) measurements from adults with obstructive and non-obstructive hypertrophic cardiomyopathy. Participants underwent provocation tests including Valsalva while continuous non-invasive hemodynamic monitoring recorded SBP waveform changes. The study analyzes correlations between SBP waveform patterns and LVOTG to determine whether SBP dynamics can indicate presence or severity of obstruction. Results were explored for use in different clinical scenarios, such as follow-up monitoring and provocation testing.
Why it matters
Potential benefit: If successful, this approach could provide an easier, continuous, non-invasive way to detect or monitor LVOT obstruction and reduce reliance on repeated echocardiography for some patients.
How similar studies have gone: Prior research has suggested links between SBP changes and LVOT gradients, but using continuous non-invasive SBP waveform monitoring as a diagnostic or monitoring tool remains relatively novel and not yet widely validated.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:1: ① Age ≥ 18 years 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. \- Exclusion Criteria: * 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.
Where it's running
-
Zhongshan Hospital
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Ziqing Yu, PhD
- Email: yu.ziqing@zs-hospital.sh.cn
- Phone: +86 18833221133
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Transitioning from mavacamten to aficamten in obstructive HCM
This study tests whether switching from mavacamten to aficamten is feasible and safe for people with obstructive hypertrophic cardiomyopathy who are already on mavacamten.
-
68Ga-NI-FAPI-04 PET/CT imaging to detect fibroblast activation in cancer, fibrotic, and heart diseases
This test will see if an injected PET tracer called 68Ga-NI-FAPI-04 can better show fibroblast activation in people with tumors, pulmonary fibrosis, certain autoimmune vascular diseases, hypertrophic cardiomyopathy, or other cardiovascular conditions.
-
Understanding why AF happens and is harder to treat in hypertrophic cardiomyopathy
We’re testing how heart electrical signals and advanced imaging relate to atrial fibrillation in people with hypertrophic cardiomyopathy to see if treatments can be improved.
-
UK multicentre hypertrophic cardiomyopathy registry
This project collects health information from adults with hypertrophic cardiomyopathy across UK NHS hospitals to see which treatments and tests work best for different patients.
-
Multimodal analysis of heart biopsy samples
This project will take one extra small heart biopsy during a clinically needed procedure to test whether detailed molecular and immune analyses can find disease-specific signatures in adults with cardiomyopathies, myocarditis, cardiac amyloidosis, or after heart transplant.
-
T1 mapping to characterize heart tissue in common heart diseases
This project tests whether T1 mapping MRI scans, including dye-free native T1, can define normal and disease-specific heart tissue values for adults with various heart conditions.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.