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

NCT06196086 | Recruiting

• 1 other identifier: YXLL-KY-2023（152）
• Study Type: observational
• Target: 438
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Preserved Ejection Fraction

Outcome Measures

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.

  After recruiting, IVP collected through software post-processing analysis will be assessed and reported up to 8 weeks.

Study Arms (2)

HFpEF

Patients who diagnosed with heart failure with preserved ejection fraction based on symptoms, serum biomarker and test according to 2022 AHA/ACC/HFSA Guidelines for Heart Failure Management at the First Affiliated Hospital of Shandong First Medical University from December 20, 2023 to December 20, 2026.

Diagnostic Test: Echocardiography examination

Control

Healthy volunteers with no history of heart disease who matched for age, sex, and risk factors with HFpEF group.

Diagnostic Test: Echocardiography examination

Interventions

Echocardiography examination DIAGNOSTIC_TEST

Echocardiography examination and software post-processing analysis was performed to obtain parameters of conventional echocardiography, left atrial and left ventricle strain, and IVP.

Control; HFpEF

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who diagnosed with HFpEF according to the 2022 AHA/ACC/HFSA Guidelines for Heart Failure Management.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haiyan Wang: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, 250000, China

RECRUITING

Study Officials

• Haiyan Wang

  Shandong First Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haiyan Wang, MD

CONTACT

13583184107; wanghaiyan96@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 23, 2023
• First Posted: January 9, 2024
• Study Start: December 20, 2023
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 20, 2027
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)