Myocardial Stiffness Evaluation in Patients With Heart Failure With Preserved Ejection Fraction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorHaiyan Wang
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Patients who diagnosed with HFpEF according to the 2022 AHA/ACC/HFSA Guidelines for Heart Failure Management.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Echocardiography examination
Diagnostic testEchocardiography examination and software post-processing analysis was performed to obtain parameters of conventional echocardiography, left atrial and left ventricle strain, and IVP.
Treatment groups
438 Participants
are divided into 2 treatment groupsGroup A: HFpEF1 intervention
Group B: Control1 intervention
Trial outcomes
Primary outcomes
1
IVP
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.
Time frame
After recruiting, IVP collected through software post-processing analysis will be assessed and reported up to 8 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Haiyan Wang
Lead sponsor
Qianfoshan Hospital
Sponsor institution
Source ClinicalTrials.gov