Pulmonary Arterial HypertensionRETRIEVENCT01905189
Resynchronisation Therapy of Right Ventricle in Pulmonary Arterial Hypertension
A study testing Resynchronization therapy of right ventricle in people with Pulmonary Arterial Hypertension, run by University Hospital, Caen at 1 site in France.
Trial summary
Pulmonary arterial hypertension is a disease characterised by pathological changes in the pulmonary arteries leading to a progressive increase in pulmonary vascular resistance and pulmonary artery pressure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Resynchronization therapy of right ventricle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2013to Jun 2014
- Phase
- Interventional
- 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
Who may be able to join
- Pulmonary hypertension type I, III, IV, V Dana Point classification
- NYHA classification equal or superior to stage II
- During right catetherization : cardiac index inferior or equal 2.5 L/mn/m2 and atrial pressure superior or equal 10 mmHg OR cardiac index equal or inferior to 2.2 L/mn/m2
- Optimal therapy considered by the referring specialist practioner of the patient
Who cannot join
- Minor or incapacitated adult
- Pregnancy
- Unability to give free and informed consent
- Pulmonary hypertension type II Dana Point classification
- Eisenmenger syndrome
- Patent foramen ovale
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- Left bundle-brach block
- Pulmonary hypertension exacerbation
- Medical clinical situation considered inappropriate by the investigator
- Patient eligible for a heart-lung transplant
- Patient eligible for pulmonary endarterectomy
- Patient with poor echogenicity
- Filter in the inferior vena cava
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Caen UH
Caen, Basse-Normandie, 14000
Paul-Ursmar Milliez, +33231065118, milliez-p@chu-caen.fr
Arnaud Pellissier, +33231065118, pellissier-a@chu-caen.fr
About this study
Pulmonary arterial hypertension is a disease characterised by pathological changes in the pulmonary arteries leading to a progressive increase in pulmonary vascular resistance and pulmonary artery pressure. Right ventricular failure is the main cause of death in patients with pulmonary arterial hypertension, and the ability of the right ventricle to adapt to the progressive increase in pulmonary vascular resistance associated with changes to the pulmonary vasculature in pulmonary arterial hypertension is the main determinant of a patient's functional capacity and survival.
Right ventricular dyssynchrony was present in a substantial proportion of patients with pulmonary arterial hypertension and this dyssynchrony adversely affected right ventricular function.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Resynchronization therapy of right ventricle
- Keywords
- pulmonary arterial hypertension, cardiac resynchronization therapy
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resynchronization therapy of right ventricleProcedure or surgery
Right atrio-ventricular resynchronization therapy combined with right intra-ventricular resynchronization therapy
| Study group | Role | What they receive |
|---|---|---|
| Hemodynamic study, cardiac pacing | Experimental | We propose to study the hemodynamic response to a temporary atrio-dual right ventricular stimulation in pulmonary arterial hypertension subjects.Patients will be is own comparator. Receives: Procedure: Resynchronization therapy of right ventricle |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac index measured during right catheterization
Measured: After two minutes of right stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul-Ursmar Milliez, Principal investigator, Caen UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905189
- Sponsor's protocol ID
- 2012-A01612-41
- Acronym
- RETRIEVE
- Status last verified
- Apr 2014
- First submitted
- 18 Jul 2013
- Last updated
- 9 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resynchronisation Therapy of Right Ventricle in Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT01905189
- Acronym / sponsor ID
- RETRIEVE / 2012-A01612-41
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- pulmonary arterial hypertension, cardiac resynchronization therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 23 Jul 2013 (estimated)
- 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.
Pulmonary arterial hypertension is a disease characterised by pathological changes in the pulmonary arteries leading to a progressive increase in pulmonary vascular resistance and pulmonary artery pressure. Right ventricular failure is the main cause of death in patients with pulmonary arterial hypertension, and the ability of the right ventricle to adapt to the progressive increase in pulmonary vascular resistance associated with changes to the pulmonary vasculature in pulmonary arterial hypertension is the main determinant of a patient's functional capacity and survival.
Right ventricular dyssynchrony was present in a substantial proportion of patients with pulmonary arterial hypertension and this dyssynchrony adversely affected right ventricular function.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemodynamic study, cardiac pacing | Experimental | Procedure: Resynchronization therapy of right ventricleWe propose to study the hemodynamic response to a temporary atrio-dual right ventricular stimulation in pulmonary arterial hypertension subjects.Patients will be is own comparator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pulmonary hypertension type I, III, IV, V Dana Point classification
- NYHA classification equal or superior to stage II
- During right catetherization : cardiac index inferior or equal 2.5 L/mn/m2 and atrial pressure superior or equal 10 mmHg OR cardiac index equal or inferior to 2.2 L/mn/m2
- Optimal therapy considered by the referring specialist practioner of the patient
Key exclusion criteria (13 listed)
- Minor or incapacitated adult
- Pregnancy
- Unability to give free and informed consent
- Pulmonary hypertension type II Dana Point classification
- Eisenmenger syndrome
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 |
|---|---|---|
| Resynchronization therapy of right ventricleRight atrio-ventricular resynchronization therapy combined with right intra-ventricular resynchronization therapy | Procedure or surgery | Hemodynamic study, cardiac pacing |
Primary outcome
cardiac index measured during right catheterization
Time frame: After two minutes of right stimulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2014.
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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.
Paul-Ursmar Milliez principal investigator
Caen UH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resynchronization therapy of right ventricle in people with Pulmonary Arterial Hypertension, run by University Hospital, Caen at 1 site in France.
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 4 inclusion and 13 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 9 Apr 2014. 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 France. 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?
Contact Paul-Ursmar Milliez, MD, PhD (+33231065118, milliez-p@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiac index measured during right catheterization (time frame: After two minutes of right stimulation). 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 9 Apr 2014.