Valsalva blood pressure drop and obstruction of the heart's outflow tract
Safety and Efficacy of Non-invasive and Ambulatory Hemodynamic Monitoring for Evaluating the Left Ventricular Outflow Tract Obstruction in Hypertrophic Cardiomyopathy
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 |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07483125 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality
- Zhongshan Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Ziqing Yu, PhD
- Email: yu.ziqing@zs-hospital.sh.cn
- Phone: +86 18833221133
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.