Clinical trial NCT06023134: Clinical Characteristics and Outcomes of Patients With Pulmonary Hypertension Associated Right Heart Failure
Official title: Clinical Characteristics and Outcomes of Patients With Pulmonary Hypertension Associated Right Heart Failure
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Right Heart Failure
Pulmonary Hypertension
Keywords: Right heart failure
Prognosis
Right ventricular function
Pulmonary hypertension
Biomarkers
diagnosis
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Time to first event of adjudicated CV death mortality or adjudicated HHF
timeFrame: 24 weeks
Secondary outcomes:
measure: Occurrence of adjudicated HHF (first and recurrent)
timeFrame: 24 weeks
measure: Time to adjudicated CV death
timeFrame: 24 weeks
measure: Time to all-cause mortality
timeFrame: 24 weeks
measure: Time to first all-cause hospitalisation
timeFrame: 24 weeks
measure: Composite of time to first event of all-cause mortality and all cause hospitalisation
timeFrame: 24 weeks
measure: Change in NYHA class from baseline at week 24
timeFrame: 24 weeks
measure: Changes in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) from baseline over time
timeFrame: 24 weeks
measure: Change in liver functions from baseline over time
timeFrame: 24 weeks
measure: Change in renal function from baseline over time
timeFrame: 24 weeks
measure: Change in echocardiographic data from baseline over time
timeFrame: 24 weeks
measure: Change in ECG data from baseline over time
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
affiliation: China-Japan Friendship Hospital
name: Jingyi Ren
role: PRINCIPAL_INVESTIGATOR
References: