Evaluating heart muscle stiffness in patients with heart failure

Evaluation of Myocardial Stiffness in Patients With Heart Failure With Preserved Ejection Fraction by Intrinsic Wave Velocity Propagation

This study is testing how stiff the heart muscle is in people with heart failure to see how it affects their heart function and the chances of needing to go back to the hospital.

Quick facts

• Study type: Observational
• Enrollment: 438 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Qianfoshan Hospital (other)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06196086 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate myocardial stiffness in patients diagnosed with heart failure with preserved ejection fraction (HFpEF) using intrinsic wave velocity propagation (IVP). Participants will undergo transthoracic echocardiography to assess various cardiac parameters, including two-dimensional strain and IVP, while also collecting clinical data and laboratory results. The study seeks to determine the relationship between myocardial stiffness and cardiac structure/function, as well as identify risk factors associated with rehospitalization in HFpEF patients. Follow-up will be conducted through electronic medical records or telephone interviews until patient rehospitalization occurs.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with heart failure with preserved ejection fraction who meet specific clinical criteria.

Not a fit: Patients with acute coronary syndrome, severe valvular heart disease, or other significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of heart failure with preserved ejection fraction, potentially reducing rehospitalization rates.

How similar studies have performed: While this approach is focused on myocardial stiffness in HFpEF, similar studies have shown promise in understanding cardiac function and rehospitalization risks in heart failure patients.

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.

Where this trial is running

Jinan, Shandong

• The First Affiliated Hospital of Shandong First Medical University — Jinan, Shandong, China (RECRUITING)

Study contacts

• Principal investigator: Haiyan Wang — Shandong First Medical University
• Study coordinator: Haiyan Wang, MD

Conditions: Heart Failure With Preserved Ejection Fraction