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

NCT06023134 | Active Not Recruiting DMC

• 1 other identifier: PH-RHF
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Right Heart Failure; Pulmonary Hypertension

Keywords

Right heart failure; Prognosis; Right ventricular function; Pulmonary hypertension; Biomarkers; diagnosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Occurrence of adjudicated HHF (first and recurrent)

  24 weeks

• Time to adjudicated CV death

  24 weeks

• Time to all-cause mortality

  24 weeks

• Time to first all-cause hospitalisation

  24 weeks

• Composite of time to first event of all-cause mortality and all cause hospitalisation

  24 weeks

Study Arms (3)

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; Diagnostic Test: Right heart catheterization

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; Diagnostic Test: Right heart catheterization

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; Diagnostic Test: Right heart catheterization

Interventions

Echocardiography DIAGNOSTIC_TEST

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.

Control group; Pulmonary Hypertension group; Right heart failure group

Right heart catheterization DIAGNOSTIC_TEST

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.

Control group; Pulmonary Hypertension group; Right heart failure group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participants who met the indications for right heart catheterization were monitored by hemodynamics and evaluated cardiac function by echocardiography. Those who met the diagnostic criteria for pulmonary hypertension were included in the pulmonary hypertension group, those who also met the diagnostic criteria for right heart failure were included in the right heart failure group, and the rest of the patients were included in the control group.

You may qualify if:

• Aged ≥18 years at the time of consent
• Acceptation of right heart catheterization examination
• Able to perform the entire protocol

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jingyi Ren: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Heart Failure; Hypertension, Pulmonary; Disease

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Jingyi Ren

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 5, 2023
• Study Start: January 1, 2015
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)