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Active, Not Recruiting

NCT Number: NCT06023134

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Right Heart Failure Cardiovascular Diseases Disease Heart Diseases Heart Failure Hypertension Hypertension, Pulmonary Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Hypertension Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Time to first event of adjudicated CV death mortality or adjudicated HHF

    Time frame: 24 weeks

    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.

Secondary outcomes

  1. Occurrence of adjudicated HHF (first and recurrent)

    Time frame: 24 weeks

    any hospital admission due to HHF in 24 weeks

  2. Time to adjudicated CV death

    Time frame: 24 weeks

    any CV death in 24 weeks

  3. Time to all-cause mortality

    Time frame: 24 weeks

    any all-cause mortality in 24 weeks

  4. Time to first all-cause hospitalisation

    Time frame: 24 weeks

    any hospital admission in 24 weeks

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

    Time frame: 24 weeks

    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

  6. Change in NYHA class from baseline at week 24

    Time frame: 24 weeks

    Patients are assessed for NYHA class at each admission

  7. Changes in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) from baseline over time

    Time frame: 24 weeks

    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

  8. Change in liver functions from baseline over time

    Time frame: 24 weeks

    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

  9. Change in renal function from baseline over time

    Time frame: 24 weeks

    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

  10. Change in echocardiographic data from baseline over time

    Time frame: 24 weeks

    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

  11. Change in ECG data from baseline over time

    Time frame: 24 weeks

    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

Sponsors and collaborators

Lead sponsor

Jingyi Ren

Other

Registry information

Important dates

Study start
2015
Primary completion
2025
Study completion
2025
First posted
Sep 5, 2023
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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