Heart Failure, SystolicNCT07050706
The Correlation Between Serum PRMT5 Level and Cardiac Ultrasound Indicators in Patients With Heart Failure
An observational study of Heart Failure, Systolic, run by The University of Hong Kong-Shenzhen Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Systolic
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study evaluated whether serum PRMT5 levels could predict echocardiographic parameters in healthy controls and heart failure patients. A total of 50 participants in the healthy group and 50 in the heart failure group completed the study.
Who may be able to join
- 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%.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
the University of Hongkong-Shenzhen Hospital
Shenzhen, Guangdong, 518033
About this study
Official title: Study on the Correlation Between Serum PRMT5 Level and Cardiac Structural and Functional 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.
Read the detailed description
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.
- Conditions
- Heart Failure, Systolic
- Keywords
- PRMT5, Heart failure, cardiac function and cardiac structure
- Medical subject headings
- Heart Failure, Systolic, Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum PRMT5 level at baseline
Serum PRMT5 level is analysed at the day of informed consent agreement and blood sampling
Measured: Baseline (day of informed consent agreement and blood sampling)
LVIDs level at baseline
Left ventricular internal diameter at systolic state is measured at the day of informed consent agreement and cardiac ultrasound examination
Measured: Baseline
LVIDd level at baseline
Left ventricular internal diameter at diastolic state is measured at the day of informed consent agreement and cardiac ultrasound examination
Measured: Baseline
LVPWs level at baseline
left ventricular posterior wall at systolic state is measured at the day of informed consent agreement and cardiac ultrasound examination
Measured: Baseline
LVPWd level at baseline
left ventricular posterior wall at diastole state is measured at the day of informed consent agreement and cardiac ultrasound examination
Measured: Baseline
IVSTs at baseline
Interventricular septum at systolic state is measured at the day of informed consent agreement and cardiac ultrasound examination
Measured: Baseline
IVSTd at baseline
Interventricular septum at diastolic state is measured at the day of informed consent agreement and cardiac ultrasound examination
Measured: Baseline
EF at 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)
Measured: Baseline
FS at baseline
Fractional shortening is calculated based on the formula below:
FS=(LVIDd-LVIDs)/LVIDd*100%
Measured: Baseline
LVMi at 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)
Measured: Baseline
RWT at baseline
Relative wall thickness is calculated according to the formula below:
RWT=2*(IVSd+LVPWd)/LVIDd
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 Jan 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, SystolicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong-Shenzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cai Sidong, The University of Hong Kong-Shenzhen Hospital
- Investigators
- Assistant research fellow, Principal investigator, The University of Hong Kong-Shenzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050706
- Sponsor's protocol ID
- PRMT5 and Heart Failure
- Other IDs
- 82300446, 2022A1515111093, RCBS20231211090745071
- Status last verified
- Jun 2025
- First submitted
- 13 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Correlation Between Serum PRMT5 Level and Cardiac Structural and Functional Indicators in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT07050706
- Acronym / sponsor ID
- PRMT5 and Heart Failure
- Conditions
- Heart Failure, Systolic
- Keywords
- PRMT5, Heart failure, cardiac function and cardiac structure
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The University of Hong Kong-Shenzhen HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study evaluated whether serum PRMT5 levels could predict echocardiographic parameters in healthy controls and heart failure patients. A total of 50 participants in the healthy group and 50 in the heart failure group completed the study.
Key inclusion criteria (2 listed)
- 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%.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
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
IVSTs at baseline
Time frame: Baseline
Interventricular septum at systolic state is measured at the day of informed consent agreement and cardiac ultrasound examination
IVSTd at baseline
Time frame: Baseline
Interventricular septum at diastolic state is measured at the day of informed consent agreement and cardiac ultrasound examination
EF at baseline
Time frame: Baseline
Ejection fraction is calculated according to the formula below: 1. EF=(LVEDV-LVESV)/LVEDV*100%; 2. LVEDV=(7.0*LVIDd^3)/(2.4+LVIDd) 3. LVESV=(7.0*LVIDs^3)/(2.4+LVIDs)
FS at baseline
Time frame: Baseline
Fractional shortening is calculated based on the formula below: FS=(LVIDd-LVIDs)/LVIDd*100%
LVMi at baseline
Time frame: Baseline
Left ventricular mass index is calculated according to the formula below: 1. LVMi(g/m^2)=LVM/BSA; 2. LVM(g)=LVM=0.8×1.04×[(LVIDd+IVSd+LVPWd)^3-LVIDd^3]+0.6; 3. BSA(m^2)=0.007184×W^0.425×H^0.725 (W: Weight, kg; H: Height, cm)
RWT at baseline
Time frame: Baseline
Relative wall thickness is calculated according to the formula below: RWT=2*(IVSd+LVPWd)/LVIDd
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Assistant research fellow principal investigator
The University of Hong Kong-Shenzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, Systolic, run by The University of Hong Kong-Shenzhen Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum PRMT5 level at baseline (time frame: Baseline (day of informed consent agreement and blood sampling)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.