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Clinical Trials in China / NCT06196086
Recruiting Observational

Myocardial Stiffness Evaluation in Patients With Heart Failure With Preserved Ejection Fraction

NCT06196086 · tracked via the Priya Life Science China tracker
Sponsor
Haiyan Wang
Phase
Observational
Started
2023-12-20
Last updated
2024-01-09

Condition(s) studied

Heart Failure With Preserved Ejection Fraction

Investigational drug(s) / intervention(s)

Echocardiography examination

Echocardiography examination: Echocardiography examination and software post-processing analysis was performed to obtain parameters of conventional echocardiography, left atrial and left ventricle strain, and IVP.

Study summary

The goal of this observational study is to evaluating myocardial stiffness in patients with heart failure with preserved ejection fraction (HFpEF) by intrinsic wave velocity propagation (IVP). The main questions it aims to answer are:

* Whether myocardial stiffness assessed by IVP in patients with HFpEF Increased.
* Whether IVP is related to the cardiac structure and function in patients with HFpEF.
* What are the risk factors that may be associated with heart failure rehospitalization in patients with HFpEF?
* Whether increased myocardial stiffness is a risk factor for heart failure rehospitalization.

Participants will undergo transthoracic echocardiography to obtain conventional ultrasound parameters, and software post-processing analysis to obtained two-dimensional strain parameters and IVP, as well as general clinical data and laboratory test results. Clinical followed up was performed through electronic medical records or telephone interviews until patient rehospitalization for heart failure or discharge for one year.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
Inclusion Criteria: Meet the diagnostic criteria for HFpEF in the 2022 AHA/ACC/HFSA Guidelines for Heart Failure Management: * Present with signs and symptoms of heart failure; * LVEF≥50%; * There is at least one additional criterion: Increased BNP (BNP≥35pg/ml, NT-pro BNP\>125pg/ml) and resting echocardiography measured E/e' ≥ 15; Stress echocardiography determined E/e' ≥ 15; Cardiac catheterization at rest, PCWP ≥ 15 mmHg or LVEDP ≥ 16 mmHg; The PCWP at peak exercise was ≥ 25 mmHg. Exclusion Criteria: * Acute coronary syndrome, acute heart failure or coronary revascularization in three months; * HFimpEF, cardiomyopathy, severe valvular heart disease, arrhythmia; * Thyroid dysfunction, pulmonary hypertension, past or current pulmonary embolism, severe chronic obstructive pulmonary disease, malignancy/renal failure (less than 30) ml/min); * Poor echocardiogram image quality.

Primary outcome measure(s)

  • IVP — After recruiting, IVP collected through software post-processing analysis will be assessed and reported up to 8 weeks.
    The propagating wave velocity along longitudinal tissue motion direction is referred to as the Intrinsic Velocity Propagation (IVP). It is generated through the dynamic nature of the heart and allows quantification in all LV segments. It is possible that this wave is related to tissue stiffness and has a radial component.

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Shandong First Medical University Jinan Shandong Recruiting

More Haiyan Wang trials in China

Pacemaker-related Tricuspid Regurgitation Progression and Long-term Outcomes Recruiting

Other trials for the same condition

Study of JK07 in Patients With Chronic Heart Failure Active, not recruiting
Study on Heart Failure with Preserved Ejection Fraction with Qishen Granules Recruiting
Pulmonary Artery Denervation for Heart Failure With Preserved Left Ventricular Ejection Fraction Starting soon
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity Recruiting
A Phase II Clinical Trial of HRS-1893 in the Treatment of Heart Failure With Preserved Ejection Fraction Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06196086 on ClinicalTrials.gov ↗ ← All trials in China