Clinical Characteristics and Outcomes of Patients With Pulmonary Hypertension Associated Right Heart Failure
Study Details
Study Description
Brief Summary
The study aims to describe the clinical characteristics and clarify the predictors of the short- and long-term outcomes of RHF patients, further assist the diagnosis, risk stratification and treatment of RHF.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Right heart failure(RHF) is a clinical syndrome with symptoms, signs, and evidence of right ventricular systolic and/or diastolic dysfunction. For many years, it was largely neglected in the consideration of left-sided heart failure, while it is now evident that RHF is not only common but its presence also strongly contributes to increased morbidity and mortality. The in-hospital mortality of RHF is 7%, and the 30-day readmission rate is 20%. Therefore, diagnosis, potential treatment strategies, and prognosis improvement have become an unmet need in the field of cardiovascular disease.
In clinical practice, accurate diagnosis of RHF is the key to timely initiation of treatment and improvement of prognosis. Although current guidelines recommend clinical symptoms and signs combined with echocardiography, cardiac magnetic resonance, and other imaging means to evaluate right heart dysfunction for comprehensive diagnosis of right heart failure, the key diagnostic indicators included are inconsistent, the weight ratio of each indicator is different, the diagnostic threshold is not uniform, and the lack of comprehensive diagnostic model system brings great challenges to clinical practice.
This study aims to integrate multiple clinical biomarkers, imaging, and hemodynamic data to describe the clinical characteristics, establish noninvasive easy-to-use diagnosis models for right heart failure, and explore the risk factors for short- and long-term poor prognosis in patients with RHF.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Control group Participants met the indication for right heart catheterization but did not meet the diagnostic criteria for pulmonary hypertension and right heart failure. |
Diagnostic Test: Echocardiography
Echocardiography will be used for specific right ventricular measurements or findings: TAPSE, TAPSE:PASP ratio, tissue Doppler velocity at lateral tricuspid annulus, fractional area change, right ventricular strain, right ventricular hypertrophy, right atrial size, volumes, ejection fraction, tricuspid and pulmonary regurgitation, inferior vena cava diameter and collapsibility, shift of interventricular septum, further assisting the diagnosis of RHF.
Diagnostic Test: Right heart catheterization
Right heart catheterization is the "gold standard" for the diagnosis of PH. It also allows for direct measurement of intracardiac and pulmonary pressures, as well as cardiac output, and is commonly used to estimate right ventricular preload and afterload.
|
| Pulmonary Hypertension group Participants were classified according to the 2022 ESC/ERS guidelines for the diagnosis and treatment of pulmonary hypertension, meaning that a mean pulmonary artery pressure (mPAP) ≥20 mmHg was defined as PH. |
Diagnostic Test: Echocardiography
Echocardiography will be used for specific right ventricular measurements or findings: TAPSE, TAPSE:PASP ratio, tissue Doppler velocity at lateral tricuspid annulus, fractional area change, right ventricular strain, right ventricular hypertrophy, right atrial size, volumes, ejection fraction, tricuspid and pulmonary regurgitation, inferior vena cava diameter and collapsibility, shift of interventricular septum, further assisting the diagnosis of RHF.
Diagnostic Test: Right heart catheterization
Right heart catheterization is the "gold standard" for the diagnosis of PH. It also allows for direct measurement of intracardiac and pulmonary pressures, as well as cardiac output, and is commonly used to estimate right ventricular preload and afterload.
|
| Right heart failure group Right heart failure was considered present when RV fractional area change (FAC) was <35% or tricuspid annular systolic velocity (RV S') was <9.5 cm/s or tricuspid annular plane systolic excursion (TAPSE) <17mm. |
Diagnostic Test: Echocardiography
Echocardiography will be used for specific right ventricular measurements or findings: TAPSE, TAPSE:PASP ratio, tissue Doppler velocity at lateral tricuspid annulus, fractional area change, right ventricular strain, right ventricular hypertrophy, right atrial size, volumes, ejection fraction, tricuspid and pulmonary regurgitation, inferior vena cava diameter and collapsibility, shift of interventricular septum, further assisting the diagnosis of RHF.
Diagnostic Test: Right heart catheterization
Right heart catheterization is the "gold standard" for the diagnosis of PH. It also allows for direct measurement of intracardiac and pulmonary pressures, as well as cardiac output, and is commonly used to estimate right ventricular preload and afterload.
|
Outcome Measures
Primary Outcome Measures
- Time to first event of adjudicated CV death mortality or adjudicated HHF [24 weeks]
The composite primary endpoint for this trial is the time to first event of adjudicated CV death or adjudicated hospitalization for heart failure （HHF） in patients with right heart failure.
Secondary Outcome Measures
- Occurrence of adjudicated HHF (first and recurrent) [24 weeks]
any hospital admission due to HHF in 24 weeks
- Time to adjudicated CV death [24 weeks]
any CV death in 24 weeks
- Time to all-cause mortality [24 weeks]
any all-cause mortality in 24 weeks
- Time to first all-cause hospitalisation [24 weeks]
any hospital admission in 24 weeks
- Composite of time to first event of all-cause mortality and all cause hospitalisation [24 weeks]
The composite primary endpoint for this trial is the time to first event of all-cause mortality and all cause hospitalisation in patients with pulmonary hypertension
- Change in NYHA class from baseline at week 24 [24 weeks]
Patients are assessed for NYHA class at each admission
- Changes in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) from baseline over time [24 weeks]
Change from baseline to week 24 in N-terminal pro-brain natriuretic peptide (NT-proBNP).Baseline value was defined as the mean of all available measurements at the time of the first right heart catheterization
- Change in liver functions from baseline over time [24 weeks]
Change of transaminase or bilirubin from baseline to week 24 .Baseline value was defined as the mean of all available measurements at the time of the first right heart catheterization
- Change in renal function from baseline over time [24 weeks]
Change of estimated Glomerular Filtration Rate from baseline to week 24. The baseline value was defined as the mean of all available measurements at the time of the first right heart catheterization
- Change in echocardiographic data from baseline over time [24 weeks]
Change from baseline to week 24 in echocardiographic data. Baseline value was defined as the mean of all available measurements at the time of the first right heart catheterization
- Change in ECG data from baseline over time [24 weeks]
Change from baseline to week 24 in ECG data.Baseline value was defined as the mean of all available measurements at the time of the first right heart catheterization
Eligibility Criteria
Criteria
Inclusion Criteria:
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Aged ≥18 years at the time of consent
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Acceptation of right heart catheterization examination
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Able to perform the entire protocol
Exclusion Criteria:
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Life expectancy of less than 1 year based on the investigator's clinical judgment
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Pregnant or nursing
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Malignancy
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Planned to undergo heart transplantation or device implantation
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Acute coronary syndrome, uncontrolled severe arrhythmia and shock.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | China-Japan Friendship Hospital | Beijing | Beijing | China |
Sponsors and Collaborators
- Jingyi Ren
Investigators
- Principal Investigator: Jingyi Ren, China-Japan Friendship Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PH-RHF