Left Ventricular Mass Index Predicts Clinical Outcomes in Patients with Obstructive Hypertrophic Cardiomyopathy Undergoing Septal Myectomy (LVMI and oHCM)

September 21, 2024 updated by: Changrong Nie

Prognostic Value of Left Ventricular Mass Index in Obstructive Hypertrophic Cardiomyopathy Undergoing Septal Myectomy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

490

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100037
        • Fuwai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause death
Time Frame: One month after discharge
Any death observed one month after discharge.
One month after discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
composite endpoint
Time Frame: 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.
One month after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changrong Nie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2011

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

September 21, 2024

First Submitted That Met QC Criteria

September 21, 2024

First Posted (Actual)

September 24, 2024

Study Record Updates

Last Update Posted (Actual)

September 24, 2024

Last Update Submitted That Met QC Criteria

September 21, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-1315
  • 2022-GSP-GG-29 (Other Grant/Funding Number: National High Level Hospital Clinical Research Funding)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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