Right Heart FailureNCT06023134
Clinical Characteristics and Outcomes of Patients With Pulmonary Hypertension Associated Right Heart Failure
An observational study of Right Heart Failure and Pulmonary Hypertension, run by Jingyi Ren at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Right Heart Failure, Pulmonary Hypertension
- What is being tested?
- Echocardiography and Right heart catheterization
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 1 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Aged ≥18 years at the time of consent
- Acceptation of right heart catheterization examination
- Able to perform the entire protocol
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Right Heart Failure, Pulmonary Hypertension
- Being tested
- Echocardiography, Right heart catheterization
- Keywords
- Right heart failure, Prognosis, Right ventricular function, Pulmonary hypertension, Biomarkers, diagnosis
- Medical subject headings
- Heart Failure, Hypertension, Pulmonary, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic 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 catheterizationDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Participants met the indication for right heart catheterization but did not meet the diagnostic criteria for pulmonary hypertension and right heart failure. Receives: 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. Receives: 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. Receives: Diagnostic Test: Echocardiography; Diagnostic Test: Right heart catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (11)
Occurrence of adjudicated HHF (first and recurrent)
any hospital admission due to HHF in 24 weeks
Measured: 24 weeks
Time to adjudicated CV death
any CV death in 24 weeks
Measured: 24 weeks
Time to all-cause mortality
any all-cause mortality in 24 weeks
Measured: 24 weeks
Time to first all-cause hospitalisation
any hospital admission in 24 weeks
Measured: 24 weeks
Composite of time to first event of all-cause mortality and all cause hospitalisation
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
Measured: 24 weeks
Change in NYHA class from baseline at week 24
Patients are assessed for NYHA class at each admission
Measured: 24 weeks
Changes in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) from baseline over time
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
Measured: 24 weeks
Change in liver functions from baseline over time
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
Measured: 24 weeks
Change in renal function from baseline over time
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
Measured: 24 weeks
Change in echocardiographic data from baseline over time
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
Measured: 24 weeks
Change in ECG data from baseline over time
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
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start1 Jan 2015
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jingyi Ren
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jingyi Ren, China-Japan Friendship Hospital
- Investigators
- Jingyi Ren, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023134
- Sponsor's protocol ID
- PH-RHF
- Status last verified
- Feb 2025
- First submitted
- 29 Aug 2023
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics and Outcomes of Patients With Pulmonary Hypertension Associated Right Heart Failure
- ClinicalTrials.gov ID
- NCT06023134
- Acronym / sponsor ID
- PH-RHF
- Conditions
- Right Heart Failure, Pulmonary Hypertension
- Keywords
- Right heart failure, Prognosis, Right ventricular function, Pulmonary hypertension, Biomarkers, diagnosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Jingyi RenUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 5 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Diagnostic Test: Echocardiography, Diagnostic Test: Right heart catheterizationParticipants met the indication for right heart catheterization but did not meet the diagnostic criteria for pulmonary hypertension and right heart failure. |
| Pulmonary Hypertension group | – | Diagnostic Test: Echocardiography, Diagnostic Test: Right heart catheterizationParticipants 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 | – | Diagnostic Test: Echocardiography, Diagnostic Test: Right heart catheterizationRight 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Aged ≥18 years at the time of consent
- Acceptation of right heart catheterization examination
- Able to perform the entire protocol
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographyEchocardiography 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 | Control group, Pulmonary Hypertension group, Right heart failure group |
| Right heart catheterizationRight 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. | Diagnostic test | Control group, Pulmonary Hypertension group, Right heart failure group |
Primary outcome
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.
11 secondary outcomes
Occurrence of adjudicated HHF (first and recurrent)
Time frame: 24 weeks
Time to adjudicated CV death
Time frame: 24 weeks
Time to all-cause mortality
Time frame: 24 weeks
Time to first all-cause hospitalisation
Time frame: 24 weeks
Composite of time to first event of all-cause mortality and all cause hospitalisation
Time frame: 24 weeks
Change in NYHA class from baseline at week 24
Time frame: 24 weeks
Changes in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) from baseline over time
Time frame: 24 weeks
Change in liver functions from baseline over time
Time frame: 24 weeks
Change in renal function from baseline over time
Time frame: 24 weeks
Change in echocardiographic data from baseline over time
Time frame: 24 weeks
Change in ECG data from baseline over time
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Right Heart Failure
Recruiting
Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects With Reduced Ejection Fraction
Heart Failure With Reduced Ejection Fraction (HFrEF)
RecruitingObservational study
dPmax for Predicting Right Ventricular Failure After Left Ventricular Assist Device Implantation
Ventricular Dysfunction, Right
Not yet recruiting
Novel Wearable Device for Heart Failure Management
Heart Failure
Not yet recruiting
Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine
Right Ventricular Function, Prone Position
Recruiting
Bundle Branch Pacing to Preserve Ejection Fraction in Atrial Fibrillation Trial
Permanent Atrial Fibrillation, Preserved Ejection Fraction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jingyi Ren principal investigator
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Right Heart Failure and Pulmonary Hypertension, run by Jingyi Ren at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first event of adjudicated CV death mortality or adjudicated HHF (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.