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Completed

NCT Number: NCT06609382

Left Ventricular Mass Index Predicts Clinical Outcomes in Patients with 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.

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Key information

Conditions

Obstructive Hypertrophic Cardiomyopathy (oHCM) Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai hospital

Beijing, Beijing Municipality, 100037, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. All-cause death

    Time frame: One month after discharge

    Any death observed one month after discharge.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Changrong Nie

Other

Registry information

Official study title

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

Acronym: LVMI and oHCM

Important dates

Study start
2011
Primary completion
2020
Study completion
2020
First posted
Sep 24, 2024
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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