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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06023134
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Jingyi Ren
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jingyi Ren
Principal Investigator Affiliation	China-Japan Friendship Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Right Heart Failure, Pulmonary Hypertension

Additional Details

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.

Arms & Interventions

Arms

: Control group

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

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

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.

Interventions

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.

Contact a Trial Team

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International Sites

China-Japan Friendship Hospital, Beijing, Beijing, China

Status

Address

China-Japan Friendship Hospital

Beijing, Beijing,

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