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Enrolling by Invitation

NCT Number: NCT07050706

The Correlation Between Serum PRMT5 Level and Cardiac Ultrasound Indicators in Patients With Heart Failure

Pathological cardiac hypertrophy is characterized by abnormal cardiomyocyte metabolism, reduced myocardial contractility, and dysregulated synthesis of myocardial contractile proteins. This pathological process leads to progressive impairment of cardiac function and ultimately progresses to heart failure. Previous studies have demonstrated that PRMT5 exerts a significant inhibitory effect on heart failure, yet its clinical significance in the context of heart failure remains undefined. In this study, we hypothesized that serum PRMT5 may serve as a biomarker to predict cardiac structural parameters and functional indices. Therefore, we aim to analyse the correlation between serum PRMT5 levels and the following parameters-LVPWs, LVPWd, LVIDs, LVIDd, IVSTs, IVSTd, EF, FS, LVMi and RWT on the first day when participants are enrolled in this study.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

the University of Hongkong-Shenzhen Hospital

Shenzhen, Guangdong, 518033, China

About this study

The aim of this study is to collect blood samples from both healthy controls and heart failure patients and to clarify the correlation between serum PRMT5 levels on the first day of enrollment and cardiac ultrasound indicators. Serum PRMT5 levels are measured by means of enzyme-linked immunosorbent assay (ELISA). Left ventricular posterior wall thickness at end-systole (LVPWs), Left ventricular posterior wall thickness at end-diastole (LVPWd), left ventricular internal diameter at end-systole (LVIDs), left ventricular internal diameter at end-diastole (LVIDd), interventricular septum at end-systole (IVSTs) and interventricular septal septum at end-diastole (IVSTd) are measured on the first day of enrollment via echocardiography. Ejection fraction (EF), fractional shortening (FS), left ventricular mass index (LVMi), and relative wall thickness (RWT) are subsequently calculated based on LVIDd, LVPWd, and IVSTd values. Finally, the correlations between serum PRMT5 levels and the following indicators are analyzed: LVPWs, LVPWd, LVIDs, LVIDd, IVSTs, IVSTd, EF, FS, LVMi and RWT.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Healthy group: Aged ≥18 years (both sexes), systolic blood pressure (SBP) ≤120 mmHg and diastolic blood pressure (DBP) ≤80 mmHg, no history of cardiovascular diseases, ejection fraction (EF) ≥50%.

Heart failure group: Aged ≥18 years (both sexes), EF ≤50%.

Exclusion criteria

  • Exclusion criteria for healthy people: people with other underlying diseases or congenital diseases are not included in the study.
  • Exclusion criteria for patients with heart failure: patients with heart failure other metabolic diseases or congenital diseases were excluded from the study.

Treatment and study plan

Primary outcomes

  1. Serum PRMT5 level at baseline

    Time frame: Baseline (day of informed consent agreement and blood sampling)

    Serum PRMT5 level is analysed at the day of informed consent agreement and blood sampling

  2. LVIDs level at baseline

    Time frame: Baseline

    Left ventricular internal diameter at systolic state is measured at the day of informed consent agreement and cardiac ultrasound examination

  3. LVIDd level at baseline

    Time frame: Baseline

    Left ventricular internal diameter at diastolic state is measured at the day of informed consent agreement and cardiac ultrasound examination

  4. LVPWs level at baseline

    Time frame: Baseline

    left ventricular posterior wall at systolic state is measured at the day of informed consent agreement and cardiac ultrasound examination

  5. LVPWd level at baseline

    Time frame: Baseline

    left ventricular posterior wall at diastole state is measured at the day of informed consent agreement and cardiac ultrasound examination

  6. IVSTs at baseline

    Time frame: Baseline

    Interventricular septum at systolic state is measured at the day of informed consent agreement and cardiac ultrasound examination

  7. IVSTd at baseline

    Time frame: Baseline

    Interventricular septum at diastolic state is measured at the day of informed consent agreement and cardiac ultrasound examination

  8. EF at baseline

    Time frame: Baseline

    Ejection fraction is calculated according to the formula below:

    • EF=(LVEDV-LVESV)/LVEDV*100%;
    • LVEDV=(7.0*LVIDd^3)/(2.4+LVIDd)
    • LVESV=(7.0*LVIDs^3)/(2.4+LVIDs)
  9. FS at baseline

    Time frame: Baseline

    Fractional shortening is calculated based on the formula below:

    FS=(LVIDd-LVIDs)/LVIDd*100%

  10. LVMi at baseline

    Time frame: Baseline

    Left ventricular mass index is calculated according to the formula below:

    • LVMi(g/m^2)=LVM/BSA;
    • LVM(g)=LVM=0.8×1.04×[(LVIDd+IVSd+LVPWd)^3-LVIDd^3]+0.6;
    • BSA(m^2)=0.007184×W^0.425×H^0.725 (W: Weight, kg; H: Height, cm)
  11. RWT at baseline

    Time frame: Baseline

    Relative wall thickness is calculated according to the formula below:

    RWT=2*(IVSd+LVPWd)/LVIDd

Sponsors and collaborators

Lead sponsor

The University of Hong Kong-Shenzhen Hospital

Other

Registry information

Official study title

Study on the Correlation Between Serum PRMT5 Level and Cardiac Structural and Functional Indicators in Patients With Heart Failure

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 3, 2025
Registry last updated
Jul 3, 2025

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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