NCT06196086 Myocardial Stiffness Evaluation in Patients With Heart Failure With Preserved Ejection Fraction
| NCT ID | NCT06196086 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Haiyan Wang |
| Condition | Heart Failure With Preserved Ejection Fraction |
| Study Type | OBSERVATIONAL |
| Enrollment | 438 participants |
| Start Date | 2023-12-20 |
| Primary Completion | 2026-12-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 438 participants in total. It began in 2023-12-20 with a primary completion date of 2026-12-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Haiyan Wang
PRINCIPAL INVESTIGATOR
Shandong First Medical University
Frequently Asked Questions
Who can join the NCT06196086 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Heart Failure With Preserved Ejection Fraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06196086 currently recruiting?
Yes, NCT06196086 is actively recruiting participants. Contact the research team at wanghaiyan96@126.com for enrollment information.
Where is the NCT06196086 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT06196086 clinical trial?
NCT06196086 is sponsored by Haiyan Wang. The principal investigator is Haiyan Wang at Shandong First Medical University. The trial plans to enroll 438 participants.
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