Valsalva SBP Drop and LVOT Obstruction

NCT07483125 | Recruiting

• 2 other identifiers: KY2026042Ziqing Yu
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

HCM; oHCM; nHCM

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Study Arms (1)

HCM

HCM patients

Other: participants are not assigned an intervention as part of the study

Interventions

participants are not assigned an intervention as part of the study OTHER

participants are not assigned an intervention as part of the study

HCM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• : ② Diagnosed with hypertrophic cardiomyopathy (HCM) by echocardiography, with or without left ventricular outflow tract obstruction
• : ③ Conscious and mentally competent, able to understand and voluntarily sign the informed consent form
• : ④ Able to cooperate with the completion of provocation tests, non-invasive dynamic hemodynamic monitoring, and relevant follow-up examinations.

You may not qualify if:

• : ① Age ≤ 18 years, or pregnant/lactating patients
• : 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 Complicated with persistent atrial fibrillation or other severe arrhythmias that may affect the accuracy of hemodynamic monitoring
• : ④ Previous history of interventional or surgical therapy for left ventricular outflow tract obstruction, including septal ablation or myectomy
• : ⑤ Patients with other conditions considered inappropriate by the investigators (e.g., those with absolute or relative contraindications to provocation tests)
• : ⑥ Patients currently participating in other clinical studies.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Central Study Contacts

Ziqing Yu, PhD

CONTACT

+86 18833221133; yu.ziqing@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2026
• First Posted: March 19, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)