NCT06023134

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: Jingyi Ren · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Right Heart Failure
• Pulmonary Hypertension

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-01-01
• Primary completion: 2025-09-01
• Completion: 2025-12-01
• First posted: 2023-09-05
• Last updated: 2025-02-18

Locations

1 site across 1 country: China