Functional Tricuspid RegurgitationECLIPSE-HFNCT05209919
Echocardiographic Assessment and CLInical imPlication of Functional tricuSpid rEgurgitation in Heart Failure With Reduced or Preserved Ejection Fraction
An observational study of Functional Tricuspid Regurgitation, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
Purpose Functional tricuspid regurgitation (FTR) has been shown to be associated with increased morbidity and mortality in several clinical conditions, including heart failure (HF) with reduced left ventricular ejection fraction as well as pulmonary arterial hypertension (PAH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Tricuspid Regurgitation
- What is being tested?
- Transthoracic Echocardiography
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 11 Nov 2021to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients to be enrolled are 300 with heart failure and 100 with PAH, given that each center guarantees the enrollment of a minimum number of 20 patients.
Who may be able to join
- consecutive consenting outpatients with HFrEF, HFmrHF, HFpEF or PAH,
- ambulatory visit routinely planned with an echocardiographic examination,
- at the time of the visit at least moderate FTR diagnosed at echocardiography (by visual assessment),
- aged ≥ 18 years old,
- capable to sign an informed consent.
Who cannot join
- age < 18 years old,
- congenital heart disease,
- heart failure due to organic mitral or aortic valve disease. No examination will be performed in addition to what is routinely planned for patients' evaluation.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Foundation IRCCS SanMatteo Hospital
Pavia, PV, 27100
Stefano Ghio, PI, 0382501326, s.ghio@smatteo.pv.it
About this study
Official title: Echocardiographic Assessment and CLInical imPlication of Functional tricuSpid rEgurgitation in Heart Failure With Reduced or Preserved Ejection Fraction (ECLIPSE-HF)
Purpose Functional tricuspid regurgitation (FTR) has been shown to be associated with increased morbidity and mortality in several clinical conditions, including heart failure (HF) with reduced left ventricular ejection fraction as well as pulmonary arterial hypertension (PAH). We have designed a study aiming at: characterizing the echocardiographic morphology of the tricuspid valve apparatus and the pathophysiology of FTR in heart failure with reduced, mid-range or preserved left ventricular ejection fraction (HFrEF, HFmrEF, HFpEF) and in PAH patients; correlating the morphologic characteristics of tricuspid valve apparatus with hemodynamic severity of FTR; correlating the severity of FTR with the clinical condition and outcome. Methods The study will be a non-interventional, prospective, international, multicenter, longitudinal study. The minimum number of patients which are expected to be enrolled is 300 HF patients, including HFrEF, HFmrEF and HFpEF patients, whereas 100 PAH patients will serve as control. The patients will be enrolled in 20 centers in Europe, North America and Saudi Arabia. The echocardiographic parameters will be analyzed by the local investigators; a quality control committee will evaluate all data entered in the database to identify potential outliers and a random sample of 10% of cases will be blindly re-analysed in a central core-lab. Conclusions This study has been designed to improve our understanding of pathophysiological mechanisms and clinical relevance of FTR across all HF phenotypes. The results could potentially allow a more appropriate selection of heart failure patients with FTR for tricuspid valve intervention by percutaneous or surgical repair or replacement.
- Conditions
- Functional Tricuspid Regurgitation
- Being tested
- Transthoracic Echocardiography
- Keywords
- tricuspid regurgitation; heart failure
- Medical subject headings
- Tricuspid Valve Insufficiency, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic EchocardiographyDiagnostic test
Also called six minutes walking test, Physical Examination, 12-lead electrocardiogram, blood sample test
All patients undergo physical examination, ECG, Transthoracic Echocardiography, six minutes walking test and blood sample (natruretic peptides, renal and liver function)
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary arterial hypertension | All patients with pulmonary arterial hypertension and significant functional tricuspid regurgitation Receives: Diagnostic Test: Transthoracic Echocardiography | |
| HFrEF | All patients with HFrEF and significant functional tricuspid regurgitation Receives: Diagnostic Test: Transthoracic Echocardiography | |
| HFpEF | All patients with HFpEF and significant functional tricuspid regurgitation Receives: Diagnostic Test: Transthoracic Echocardiography | |
| Heart Failure mildly-reduced ejection fraction | All patients with Heart Failure mildly-reduced ejection fraction and significant functional tricuspid regurgitation Receives: Diagnostic Test: Transthoracic Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to all-cause death or to first HF hospitalization
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start11 Nov 2021
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional Tricuspid RegurgitationStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- Cardarelli Hospital, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy, Monaldi Hospital, Federico II University, Cava de Tirreni Costiera Amalfitana Hospital Salerno, Umberto I Hospital, Nocera Inferiore, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona, Azienda Ospedaliera S. Maria della Misericordia, University of Pisa, Niguarda Hospital, IRCCS Policlinico S. Donato, University of Parma, University of Siena, Foligno Hospital, University of Targu Mures, Romania, Szeged University, National Cardiology Hospital, Bulgaria, Bieganski Hospital Lodz, Poland, Departement of clinical sciences, Lund University and Skane University Hospidal, Lund Sweden, King Faisal Specialist Hospital & Research Center, Piedmont Heart Institute, Inc., Atlanta, GA, Jewish General Hospital, Ospedali Riuniti di Foggia
- Responsible party
- Principal investigator, Stefano Ghio, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209919
- Sponsor's protocol ID
- 0099915/21
- Acronym
- ECLIPSE-HF
- Status last verified
- Jan 2022
- First submitted
- 17 Dec 2021
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ghio S, Bossone E, Mercurio V, Rudski L, Vannan M; RIGHT-NET Investigators. Echocardiographic assessment and clinical implication of functional tricuspid regurgitation in heart failure with reduced or preserved ejection fraction (ECLIPSE-HF) : Rationale and design of the study. Int J Cardiovasc Imaging. 2022 Dec;38(12):2581-2591. doi: 10.1007/s10554-022-02599-8. Epub 2022 Aug 8.
PubMed 36445668
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiographic Assessment and CLInical imPlication of Functional tricuSpid rEgurgitation in Heart Failure With Reduced or Preserved Ejection Fraction (ECLIPSE-HF)
- ClinicalTrials.gov ID
- NCT05209919
- Acronym / sponsor ID
- ECLIPSE-HF / 0099915/21
- Conditions
- Functional Tricuspid Regurgitation
- Keywords
- tricuspid regurgitation; heart failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Collaborators
- Cardarelli Hospital, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy, Monaldi Hospital, Federico II University, Cava de Tirreni Costiera Amalfitana Hospital Salerno, Umberto I Hospital, Nocera Inferiore, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona, Azienda Ospedaliera S. Maria della Misericordia, University of Pisa, Niguarda Hospital, IRCCS Policlinico S. Donato, University of Parma, University of Siena, Foligno Hospital, University of Targu Mures, Romania, Szeged University, National Cardiology Hospital, Bulgaria, Bieganski Hospital Lodz, Poland, Departement of clinical sciences, Lund University and Skane University Hospidal, Lund Sweden, King Faisal Specialist Hospital & Research Center, Piedmont Heart Institute, Inc., Atlanta, GA, Jewish General Hospital, Ospedali Riuniti di Foggia
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 27 Jan 2022 (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.
Purpose Functional tricuspid regurgitation (FTR) has been shown to be associated with increased morbidity and mortality in several clinical conditions, including heart failure (HF) with reduced left ventricular ejection fraction as well as pulmonary arterial hypertension (PAH). We have designed a study aiming at: characterizing the echocardiographic morphology of the tricuspid valve apparatus and the pathophysiology of FTR in heart failure with reduced, mid-range or preserved left ventricular ejection fraction (HFrEF, HFmrEF, HFpEF) and in PAH patients; correlating the morphologic characteristics of tricuspid valve apparatus with hemodynamic severity of FTR; correlating the severity of FTR with the clinical condition and outcome. Methods The study will be a non-interventional, prospective, international, multicenter, longitudinal study. The minimum number of patients which are expected to be enrolled is 300 HF patients, including HFrEF, HFmrEF and HFpEF patients, whereas 100 PAH patients will serve as control. The patients will be enrolled in 20 centers in Europe, North America and Saudi Arabia. The echocardiographic parameters will be analyzed by the local investigators; a quality control committee will evaluate all data entered in the database to identify potential outliers and a random sample of 10% of cases will be blindly re-analysed in a central core-lab. Conclusions This study has been designed to improve our understanding of pathophysiological mechanisms and clinical relevance of FTR across all HF phenotypes. The results could potentially allow a more appropriate selection of heart failure patients with FTR for tricuspid valve intervention by percutaneous or surgical repair or replacement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pulmonary arterial hypertension | – | Diagnostic Test: Transthoracic EchocardiographyAll patients with pulmonary arterial hypertension and significant functional tricuspid regurgitation |
| HFrEF | – | Diagnostic Test: Transthoracic EchocardiographyAll patients with HFrEF and significant functional tricuspid regurgitation |
| HFpEF | – | Diagnostic Test: Transthoracic EchocardiographyAll patients with HFpEF and significant functional tricuspid regurgitation |
| Heart Failure mildly-reduced ejection fraction | – | Diagnostic Test: Transthoracic EchocardiographyAll patients with Heart Failure mildly-reduced ejection fraction and significant functional tricuspid regurgitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients to be enrolled are 300 with heart failure and 100 with PAH, given that each center guarantees the enrollment of a minimum number of 20 patients.
Key inclusion criteria (5 listed)
- consecutive consenting outpatients with HFrEF, HFmrHF, HFpEF or PAH,
- ambulatory visit routinely planned with an echocardiographic examination,
- at the time of the visit at least moderate FTR diagnosed at echocardiography (by visual assessment),
- aged ≥ 18 years old,
- capable to sign an informed consent.
Key exclusion criteria (3 listed)
- age < 18 years old,
- congenital heart disease,
- heart failure due to organic mitral or aortic valve disease. No examination will be performed in addition to what is routinely planned for patients' evaluation.
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 |
|---|---|---|
| Transthoracic EchocardiographyAlso: six minutes walking test, Physical Examination, 12-lead electrocardiogram, blood sample testAll patients undergo physical examination, ECG, Transthoracic Echocardiography, six minutes walking test and blood sample (natruretic peptides, renal and liver function) | Diagnostic test | HFpEF, HFrEF, Heart Failure mildly-reduced ejection fraction, Pulmonary arterial hypertension |
Primary outcome
Time to all-cause death or to first HF hospitalization
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Derived from this study: PubMed 36445668Ghio S, Bossone E, Mercurio V, Rudski L, Vannan M; RIGHT-NET Investigators. Echocardiographic assessment and clinical implication of functional tricuspid regurgitation in heart failure with reduced or preserved ejection fraction (ECLIPSE-HF) : Rationale and design of the study. Int J Cardiovasc Imaging. 2022 Dec;38(12):2581-2591. doi: 10.1007/s10554-022-02599-8. Epub 2022 Aug 8.
- Individual participant dataSharing planned: No
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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.
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 Functional Tricuspid Regurgitation, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Jan 2022. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to all-cause death or to first HF hospitalization (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05209919, which also lists 1 linked publication.
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 27 Jan 2022.