NCT07483125

Valsalva SBP Drop and LVOT Obstruction

Safety and Efficacy of Non-invasive and Ambulatory Hemodynamic Monitoring for Evaluating the Left Ventricular Outflow Tract Obstruction in Hypertrophic Cardiomyopathy

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• HCM
• oHCM
• nHCM

Interventions

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

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2026-03-19
• Last updated: 2026-03-19

Locations

1 site across 1 country: China