Left Ventricular Mass Index Predicts Clinical Outcomes in Patients with Obstructive Hypertrophic Cardiomyopathy Undergoing Septal Myectomy

Completed

• Conditions: Obstructive Hypertrophic Cardiomyopathy (oHCM)

• Registration Number: NCT06609382
• Lead Sponsor: Changrong Nie

Brief Summary

In this study, we aimed to analyze the association between left ventricular mass index and clinical outcomes to provide the potential indicator for worse survival.

Detailed Description

This retrospective study aimed to determine the prognostic value of left ventricular mass index in predicting clinical outcomes, including all-cause death, new-onset or recurrent atrial fibrillation, and a composite endpoint of all-cause death, heart failure,permanent pacemaker implantation, new-onset or recurrent atrial fibrillation, and stroke.

Study Timeline

• Study Start: 2011-06-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2024-09
• Study First Submitted: 2024-09-21
• Study First Submitted QC: 2024-09-21
• Last Update Submitted: 2024-09-21
• Study First Posted: 2024-09-24
• Last Update Posted: 2024-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 490

Inclusion Criteria

(1) Difficulty in relieving symptoms with medication or recurrent syncope. (2) Left ventricular outflow tract (LVOT) pressure gradient ≥ 50 mmHg at rest or with provocation and the maximum thickness of the septum is ≧ 15 mm.

Exclusion Criteria

• (1) Combined right ventricular outflow tract obstruction requiring right ventricular outflow tract dissection. (2) Combined mitral or aortic valve organic lesions requiring valve replacement surgery. (3) Apical ventricular aneurysm formation requiring ventriculotomy. (4) Previous septal reduction therapy, including alcohol ablation or septal myectomy. (5) patients did not undergo cardiac magnetic resonance examination.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause death	One month after discharge	Any death observed one month after discharge.

Secondary Outcome Measures

Name	Time	Method
composite endpoint	One month after discharge	Composite endpoint included all-cause death, and nonfatal adverse events, with nonfatal adverse events defined as rehospitalization for heart failure, permanent pacemaker implantation, new-onset or recurrent atrial fibrillation, and stroke.

Trial Locations

Locations (1)

Fuwai hospital; 🇨🇳 Beijing, Beijing, China