NCT06196086Recruiting
Myocardial Stiffness Evaluation in Patients With Heart Failure With Preserved Ejection Fraction
Evaluation of Myocardial Stiffness in Patients With Heart Failure With Preserved Ejection Fraction by Intrinsic Wave Velocity Propagation
Source: ClinicalTrials.gov · Last updated 9 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 438 (estimated)
- First submitted
- 23 Dec 2023
- Start date
- 20 Dec 2023
- Primary completion date
- 20 Dec 2026
- Lead sponsor
- Haiyan Wang
- Diseases
- Heart failure
- NCT number
- NCT06196086
What you commit to
- Study type: Observational
- Planned participants: 438
- From 20 Dec 2023 to the primary completion date, 20 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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);
Other
- Poor echocardiogram image quality.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Shandong First Medical University Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.