- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05954481
Stress-Echography in Hereditary Haemorrhagic Telangiectasia Patient With Hepatic Involvement (ROSE)
Evaluation of the Value of Measuring Pulmonary Arterial Pressures During Exercise in Hereditary Haemorrhagic Telangiectasia Patients With Hepatic Involvement - Pilot Study
The hepatic involvement of HHT (Hereditary Haemorrhagic Telangiectasia) disease is characterised by the formation of arterio-sus-hepatic shunts which lead to dilatation of the hepatic artery and may result in high output heart failure. This evolves silently for long-standing period from left ventricular cavities dilatation to advanced heart failure with post-capillary pulmonary hypertension (PH) (more rarely pre-capillary), and its evolution is poorly understood. The specific treatment options for HHT disease are either the use of anti-angiogenic therapy (bevacizumab) or liver transplantation. As rest echocardiography can only detect advanced cases or heart failure with rest PH, the investigators speculate that exercise echocardiography can provide additional information in patients without rest PH. The hypothesis is that an exaggerated pulmonary pressure increase during exercise may precede the occurrence of rest PH in the course of the disease. It could identify patients with substantial heart failure at an earlier stage and may facilitate the access to liver transplantation. These parameters have never been studied in this context and it seems interesting to evaluate them in this pilot study.
The investigators hypothesise that HHT (Hereditary Haemorrhagic Telangiectasia) patients with hepatic involvement and cardiac high output will have significantly greater and/or earlier elevation of exercise pulmonary arterial pressures than those with normal cardiac output.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sophie DUPUIS-GIROD, Dr
- Phone Number: +33 04 27 85 65 25
- Email: sophie.dupuis-girod@chu-lyon.fr
Study Contact Backup
- Name: Cyrille BERGEROT, Dr
- Phone Number: +33 04 72 11 93 61
- Email: cyrille.bergerot@chu-lyon.fr
Study Locations
-
-
-
Bron, France, 69677
- Recruiting
- Service Explorations fonctionnelles cardiovasculaires - Hôpital Louis Pradel
-
Contact:
- Cyrille BERGEROT, Dr
- Phone Number: +33 04 72 11 93 61
- Email: cyrille.bergerot@chu-lyon.fr
-
Contact:
- Helène THIBAULT, Dr
- Phone Number: +33 04 72 35 69 07
- Email: helene.thibault@chu-lyon.fr
-
Principal Investigator:
- Cyrille BERGEROT, Dr
-
Sub-Investigator:
- Helène THIBAULT, Dr
-
Bron, France, 69677
- Recruiting
- Service génétique - Hôpital Femme Mère Enfant
-
Contact:
- Sophie DUPUIS-GIROD, Dr
- Phone Number: +33 04 27 85 65 25
- Email: sophie.dupuis-girod@chu-lyon.fr
-
Principal Investigator:
- Sophie DUPUIS-GIROD, Dr
-
Sub-Investigator:
- Alexandre GUILHEM, Dr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- HHT patient > 18 yo
- Hepatic involvement (hepatic artery diameter > 6mm)
- Patient having received the information and signed the informed consent form
- Patient affiliated to a social security scheme or beneficiaries of a similar scheme
Exclusion Criteria:
- Haemoglobin < 90 g/L
- Active Infection
- Atrial Fibrillation permanent or persistent
- Known cardiopathy
- Pregnant or breastfeeding woman (by questioning)
- Adult subject to a legal protection measure (guardianship)
- Participation in another clinical trial that may interfere with the proposed trial (investigator judgment)
- Patient physically unable to pedal
- Patient with Pulmonary arteriovenous malformations awaiting embolization
- Patient treated with beta-blockers
Secondary Exclusion Criteria verified on rest ultrasound
- PAH (Pulmonary Arterial Hypertension) at rest (Vmax > 2.8 m/sec)
- Inability to obtain a stream of IT at rest
- Patient with atrial fibrillation (AF)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: HHT patients with hepatic involvement and high cardiac index
HHT patients with a dilated (diameter > 6mm) or tortuous hepatic artery and an elevated cardiac index (> 3.5 l/mn/m²)
|
After a rest trans thoracic echocardiography (usual follow-up), eligible patients will have a stress ultrasound echocardiography on a dedicated cycle ergometer
|
Other: HHT patients with hepatic involvement and normal cardiac index
HHT patients with a dilated or tortuous hepatic artery and a normal cardiac index
|
After a rest trans thoracic echocardiography (usual follow-up), eligible patients will have a stress ultrasound echocardiography on a dedicated cycle ergometer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of exercise pulmonary artery systolic pressure in patients with HHT and liver involvement.
Time Frame: Day 1
|
The systolic pulmonary artery pressure (PAPS) during exercise will be compared between the two groups of patients.
PAPS will be estimated by the maximum velocity (Vmax) of tricuspid insufficiency flow at peak exercise on cardiac ultrasound.
|
Day 1
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL22_0487
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hereditary Hemorrhagic Telangiectasia
-
Vaderis Therapeutics AGRecruitingHereditary Hemorrhagic Telangiectasia (HHT)United States, Spain, France, Belgium, Netherlands, Italy
-
Unity Health TorontoSunnybrook Health Sciences Centre; University of Pittsburgh; Duke University; Barrow... and other collaboratorsActive, not recruitingHereditary Hemorrhagic Telangiectasia (HHT)Canada
-
Imperial College LondonCompletedHereditary Hemorrhagic Telangiectasia (HHT)United Kingdom
-
University Hospital, EssenCompletedHereditary Haemorrhagic Telangiectasia (HHT)Germany
-
University of PennsylvaniaCompletedHereditary Hemorrhagic Telangiectasia (HHT)United States
-
University Hospital, EssenCompleted
-
Centre Hospitalier Universitaire DijonCompletedHereditary Hemorrhagic TelangiectasiaFrance
-
Hospices Civils de LyonCompletedHHT | Hemorrhagic Hereditary TelangiectasiaFrance
-
Hospices Civils de LyonCompletedLiver Transplant | Hereditary Haemorrhagic Telangiectasia
-
Unity Health TorontoThe Hospital for Sick Children; Sunnybrook Health Sciences Centre; National Institute... and other collaboratorsCompletedHereditary Hemorrhagic TelangiectasiaCanada
Clinical Trials on Stress echocardiography
-
Assistance Publique - Hôpitaux de ParisCompleted
-
Azienda Ospedaliera OO.RR. S. Giovanni di Dio e...RecruitingRight Ventricular DysfunctionItaly
-
University of Missouri-ColumbiaCompletedObesity | Metabolic Syndrome
-
Medical University of ViennaUnknown
-
Centre Hospitalier Universitaire de NiceCompletedPulmonary HypertensionFrance
-
Mustafa Kemal UniversityCompletedHypertension | Left Ventricular HypertrophyTurkey
-
Technical University of MunichLudwig-Maximilians - University of MunichEnrolling by invitationCardiovascular Diseases | Pediatric CancerGermany
-
China Medical University HospitalUnknownCardiovascular Diseases | STEMI | NSTEMITaiwan
-
Mayo ClinicCompletedMalignant Solid Neoplasm | Hematopoietic and Lymphoid System NeoplasmUnited States
-
Albert Einstein Healthcare NetworkLantheus Medical ImagingCompletedMitral Annulus CalcificationUnited States