Clinical trial Recruiting at 1 site Observational Ages 18 and up

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.

More Hypertrophic Cardiomyopathy (HCM) trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment800 (estimated)
SponsorShanghai Zhongshan Hospital
Academic / other
Locations1 site (Shanghai, Shanghai Municipality)
StatusRecruiting
StartedDecember 1, 2025
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedMarch 19, 2026
Trial IDNCT07483125 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.

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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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.