Clinical Characteristics and Outcomes of Patients With Pulmonary Hypertension Associated Right Heart Failure

Pulmonary Hypertension Clinical Trial

Official title:

Clinical Characteristics and Outcomes of Patients With Pulmonary Hypertension Associated Right Heart Failure

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06023134
• Other study ID #: PH-RHF
• Status: Active, not recruiting
• Start date: January 1, 2015
• Est. completion date: December 1, 2025

Study information

• Verified date: August 2023
• Source: China-Japan Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: December 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Aged =18 years at the time of consent

2. Acceptation of right heart catheterization examination

3. Able to perform the entire protocol

Exclusion Criteria:

1. Life expectancy of less than 1 year based on the investigator's clinical judgment

2. Pregnant or nursing

3. Malignancy

4. Planned to undergo heart transplantation or device implantation

5. Acute coronary syndrome, uncontrolled severe arrhythmia and shock.

Related Conditions & MeSH terms

• Heart Failure
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension
• Right Heart Failure

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jingyi Ren

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first event of adjudicated CV death mortality or adjudicated HHF	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.	24 weeks
Secondary	Occurrence of adjudicated HHF (first and recurrent)	any hospital admission due to HHF in 24 weeks	24 weeks
Secondary	Time to adjudicated CV death	any CV death in 24 weeks	24 weeks
Secondary	Time to all-cause mortality	any all-cause mortality in 24 weeks	24 weeks
Secondary	Time to first all-cause hospitalisation	any hospital admission in 24 weeks	24 weeks
Secondary	Composite of time to first event of all-cause mortality and all cause hospitalisation	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	24 weeks
Secondary	Change in NYHA class from baseline at week 24	Patients are assessed for NYHA class at each admission	24 weeks
Secondary	Changes in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) from baseline over time	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	24 weeks
Secondary	Change in liver functions from baseline over time	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	24 weeks
Secondary	Change in renal function from baseline over time	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	24 weeks
Secondary	Change in echocardiographic data from baseline over time	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	24 weeks
Secondary	Change in ECG data from baseline over time	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	24 weeks