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

NCT06609382 | Completed

• 2 other identifiers: 2020-13152022-GSP-GG-29
• Study Type: observational
• Target: 490
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Hypertrophic Cardiomyopathy (oHCM)

Keywords

left ventricular mass index; all-cause death; survival; obstructive hypertrophic cardiomyopathy; septal myectomy

Outcome Measures

Primary Outcomes (1)

• All-cause death

  Any death observed one month after discharge.

  One month after discharge

Secondary Outcomes (1)

• composite endpoint

  One month after discharge

Study Arms (1)

Obstructive hypertrophic cardiomyopathy who underwent septal myectomy

Patients who had at least one cardiac magnetic resonance examination before surgery.

Other: Patients had a higher left ventricular mass index or not （the exact value is determined by the cut-off value for the clinical outcomes)

Interventions

Patients had a higher left ventricular mass index or not （the exact value is determined by the cut-off value for the clinical outcomes) OTHER

Patients were grouped by the cutoff value of left ventricular mass index (LVMI) for all cause death, and the Maximally Selected Rank Statistics method was used to determine the optimal cutoff point of LVMI for death.

Obstructive hypertrophic cardiomyopathy who underwent septal myectomy

Eligibility Criteria

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

Study Population

oHCM who underwent septal myectomy and had at least one CMR image before surgery.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Changrong Nie: lead

Study Sites (1)

Fuwai hospital

Beijing, Beijing Municipality, 100037, China

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 21, 2024
• First Posted: September 24, 2024
• Study Start: June 1, 2011
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)