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

Jingyi Ren

Status: Active, not recruiting

Conditions: Right Heart Failure; Pulmonary Hypertension

Treatments: Diagnostic Test: Echocardiography; Diagnostic Test: Right heart catheterization

Study type: Observational

Funder types: Other

Identifiers

NCT06023134

PH-RHF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

800 participants in 3 patient groups

Control group

Description:

Participants met the indication for right heart catheterization but did not meet the diagnostic criteria for pulmonary hypertension and right heart failure.

Treatment:

Diagnostic Test: Right heart catheterization

Diagnostic Test: Echocardiography

Pulmonary Hypertension group

Description:

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.

Treatment:

Diagnostic Test: Right heart catheterization

Diagnostic Test: Echocardiography

Right heart failure group

Description:

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.

Treatment:

Diagnostic Test: Right heart catheterization

Diagnostic Test: Echocardiography