Heart Failure With Preserved Ejection FractionNCT06196086
Myocardial Stiffness Evaluation in Patients With Heart Failure With Preserved Ejection Fraction
An observational study of Heart Failure With Preserved Ejection Fraction, run by Haiyan Wang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Echocardiography examination
- How many people
- 438 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2023to 20 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who diagnosed with HFpEF according to the 2022 AHA/ACC/HFSA Guidelines for Heart Failure Management.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, 250000
Haiyan Wang, MD, 13583184107, wanghaiyan96@126.com
About this study
Official title: Evaluation of Myocardial Stiffness in Patients With Heart Failure With Preserved Ejection Fraction by Intrinsic Wave Velocity Propagation
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.
Read the 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 clinical and echocardiographic data, two-dimensional strain parameters and IVP of the study subjects were obtained:
- The echocardiographic examination was performed using a GE Vivid E95 ultrasound machine, and images were acquired with the patient in left lateral decubitus using a 3.5-5 MHz transducer at a depth of 16 cm. ECG was recorded, and 3 consecutive cardiac cycles of each view were recorded during quiet breathing at 50-80 frames/sec. All patients were subjected to conventional transthoracic echocardiography, Speckle tracking echocardiography and IVP. All measurements were taken following the American Society of Echocardiography (ASE) recommendations.
- Left atrial and left ventricle strain analysis was obtained using automated speckle tracking software. The regions of interest were generated automatically and left atrial endocardial border was manually adjusted when required. Left atrial phases definition and left atrial strain values were measured from the Left atrial longitudinal strain curve according to the European Association of Cardiovascular Imaging (EACVI)/American society of echocardiography (ASE) guidelines. Global left ventricle strain was evaluated, and the software automatically traced the contour of the endocardium at apical three, four and two-chamber views.
- For IVP analysis, we first entered Q-analysis and then used the curved anatomic M-mode to trace the left ventricle myocardium to reconstruct the axial tissue velocity maps. The tissue velocity map scale was adjusted to create velocity aliasing to better illustrate the is velocity wave front that propagated in the myocardium during end-diastole induced by atrial contraction. Sweep speed was adjusted to maximum, and the slope of the is velocity wave was measured as the propagation speed of the intrinsic wave. The average wave velocity was calculated using all measurements from all six myocardial walls using the three apical views.
- At the same time, the general clinical data, demographic characteristics, electrocardiogram, coronary artery CTA, carotid ultrasound, and laboratory results include brain natriuretic peptide (BNP), uric acid (UA), soluble growth stimulating expression gene 2 protein (sST2), growth differentiation factor 15(GDF-15), Galectin-3 (Galectin-3) were obtained through electronic health record.
- Clinical follow-up was performed every 6 months after discharge by phone and by electronic health record review until heart failure readmission or one year after discharge. Heart failure rehospitalization was defined as any rehospitalization during which HF was listed as one primary diagnosis based on typical heart failure symptoms, signs and increased B-type natriuretic peptide levels for which intravenous diuretics or increased dose of loop diuretics were needed in clinic.
- Being tested
- Echocardiography examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiography examinationDiagnostic test
Echocardiography examination and software post-processing analysis was performed to obtain parameters of conventional echocardiography, left atrial and left ventricle strain, and IVP.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Echocardiography examination | |
| Control | Healthy volunteers with no history of heart disease who matched for age, sex, and risk factors with HFpEF group. Receives: Diagnostic Test: Echocardiography examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After recruiting, IVP collected through software post-processing analysis will be assessed and reported up to 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start20 Dec 2023
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 438 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haiyan Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Haiyan Wang, Qianfoshan Hospital
- Investigators
- Haiyan Wang, Principal investigator, Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06196086
- Sponsor's protocol ID
- YXLL-KY-2023(152)
- Status last verified
- Jan 2024
- First submitted
- 23 Dec 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Myocardial Stiffness in Patients With Heart Failure With Preserved Ejection Fraction by Intrinsic Wave Velocity Propagation
- ClinicalTrials.gov ID
- NCT06196086
- Acronym / sponsor ID
- YXLL-KY-2023(152)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 438 participants (estimated)
- Lead sponsor
- Haiyan WangUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Dec 2027 (estimated)
- First posted
- 9 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 clinical and echocardiographic data, two-dimensional strain parameters and IVP of the study subjects were obtained:
- The echocardiographic examination was performed using a GE Vivid E95 ultrasound machine, and images were acquired with the patient in left lateral decubitus using a 3.5-5 MHz transducer at a depth of 16 cm. ECG was recorded, and 3 consecutive cardiac cycles of each view were recorded during quiet breathing at 50-80 frames/sec. All patients were subjected to conventional transthoracic echocardiography, Speckle tracking echocardiography and IVP. All measurements were taken following the American Society of Echocardiography (ASE) recommendations.
- Left atrial and left ventricle strain analysis was obtained using automated speckle tracking software. The regions of interest were generated automatically and left atrial endocardial border was manually adjusted when required. Left atrial phases definition and left atrial strain values were measured from the Left atrial longitudinal strain curve according to the European Association of Cardiovascular Imaging (EACVI)/American society of echocardiography (ASE) guidelines. Global left ventricle strain was evaluated, and the software automatically traced the contour of the endocardium at apical three, four and two-chamber views.
- For IVP analysis, we first entered Q-analysis and then used the curved anatomic M-mode to trace the left ventricle myocardium to reconstruct the axial tissue velocity maps. The tissue velocity map scale was adjusted to create velocity aliasing to better illustrate the is velocity wave front that propagated in the myocardium during end-diastole induced by atrial contraction. Sweep speed was adjusted to maximum, and the slope of the is velocity wave was measured as the propagation speed of the intrinsic wave. The average wave velocity was calculated using all measurements from all six myocardial walls using the three apical views.
- At the same time, the general clinical data, demographic characteristics, electrocardiogram, coronary artery CTA, carotid ultrasound, and laboratory results include brain natriuretic peptide (BNP), uric acid (UA), soluble growth stimulating expression gene 2 protein (sST2), growth differentiation factor 15(GDF-15), Galectin-3 (Galectin-3) were obtained through electronic health record.
- Clinical follow-up was performed every 6 months after discharge by phone and by electronic health record review until heart failure readmission or one year after discharge. Heart failure rehospitalization was defined as any rehospitalization during which HF was listed as one primary diagnosis based on typical heart failure symptoms, signs and increased B-type natriuretic peptide levels for which intravenous diuretics or increased dose of loop diuretics were needed in clinic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFpEF | – | Diagnostic Test: Echocardiography examinationPatients 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. |
| Control | – | Diagnostic Test: Echocardiography examinationHealthy volunteers with no history of heart disease who matched for age, sex, and risk factors with HFpEF group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who diagnosed with HFpEF according to the 2022 AHA/ACC/HFSA Guidelines for Heart Failure Management.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echocardiography examinationEchocardiography examination and software post-processing analysis was performed to obtain parameters of conventional echocardiography, left atrial and left ventricle strain, and IVP. | Diagnostic test | Control, HFpEF |
Primary outcome
IVP
Time frame: After recruiting, IVP collected through software post-processing analysis will be assessed and reported up to 8 weeks.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Haiyan Wang principal investigator
Shandong First Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Preserved Ejection Fraction, run by Haiyan Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haiyan Wang, MD (13583184107, wanghaiyan96@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IVP (time frame: After recruiting, IVP collected through software post-processing analysis will be assessed and reported up to 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.