Clinical Characteristics and Outcomes of Patients With Pulmonary Hypertension Associated Right Heart Failure
- Conditions
- Right Heart FailurePulmonary Hypertension
- Interventions
- Diagnostic Test: EchocardiographyDiagnostic Test: Right heart catheterization
- Registration Number
- NCT06023134
- Lead Sponsor
- Jingyi Ren
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 800
- Aged ≥18 years at the time of consent
- Acceptation of right heart catheterization examination
- Able to perform the entire protocol
- Life expectancy of less than 1 year based on the investigator's clinical judgment
- Pregnant or nursing
- Malignancy
- Planned to undergo heart transplantation or device implantation
- Acute coronary syndrome, uncontrolled severe arrhythmia and shock.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Control group Right heart catheterization Participants met the indication for right heart catheterization but did not meet the diagnostic criteria for pulmonary hypertension and right heart failure. Right heart failure group Right heart catheterization 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. Control group Echocardiography Participants met the indication for right heart catheterization but did not meet the diagnostic criteria for pulmonary hypertension and right heart failure. Pulmonary Hypertension group Echocardiography 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. Pulmonary Hypertension group Right heart catheterization 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. Right heart failure group Echocardiography 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
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
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
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
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 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
Trial Locations
- Locations (1)
China-Japan Friendship Hospital
🇨🇳Beijing, Beijing, China