Status:

RECRUITING

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

Lead Sponsor:

Haiyan Wang

Conditions:

Heart Failure With Preserved Ejection Fraction

Eligibility:

All Genders

18-80 years

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 mai...

Detailed Description

The included patients who diagnosed with HFpEF and healthy volunteers at the First Affiliated Hospital of Shandong First Medical University from December 20, 2023 to December 20, 2026. Routine clinica...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

December 20 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 20 2027

Estimated Enrollment :

438 Patients enrolled

Trial Details

Trial ID

NCT06196086

Start Date

December 20 2023

End Date

December 20 2027

Last Update

January 9 2024

Active Locations (1)

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1

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, China, 250000