Pulmonary Arterial HypertensionDENERV'APNCT02525926
Pulmonary Artery Denervation for Treatment of Pulmonary Arterial Hypertension
A study testing denervation in people with Pulmonary Arterial Hypertension, run by Centre Hospitalier Universitaire de Nice at 5 sites in France.
Trial summary
Pulmonary hypertension is a rare condition that leads to right ventricular dysfunction and premature death. Only modest improvements of outcomes have been observed with the current available advanced specific drug therapy. 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?
- denervation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 5 sitesFrance
- Study dates
- 4 Feb 2016to 17 Oct 2024
- 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
- Patients with pulmonary artery hypertension (group 1 of the Nice classification of pulmonary hypertension)
- Aged over 18 years old
- NYHA class III or IV
- Not controlled by optimal medical management as defined by:
- dual therapy including a prostacyclin.
- or dual therapy including an endothelin receptor antagonist and a
Show all 9Show fewer
- 5-phosphodiesterase inhibitors, in patients with contra-indication of prostacyclin, poor tolerance to this treatment, prostacyclin derivative treatment failure or patient refusal.
- Valid status in the social security system
- Signed informed consent
Who cannot join
- Patient eligible for pulmonary transplantation
- Pregnancy or breastfeeding
- Adults of the age of majority subject to guardianship court order or deprived of liberty
- Patient with history of radio frequency procedure
- Known heparin allergy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU de Grenoble
Grenoble, 38700
AP-HM
Marseille, 13354
CHU de Nice
Nice, 06000
AP-HP
Paris, 75015
CHU de Toulouse
Toulouse, 31059
About this study
Pulmonary hypertension is a rare condition that leads to right ventricular dysfunction and premature death. Only modest improvements of outcomes have been observed with the current available advanced specific drug therapy. Pulmonary hypertension advanced therapy is also expensive and leads to frequent adverse effects, sometimes serious. Results from a pilot study, the first-in-man experience of pulmonary artery denervation, demonstrated a clinical improvement in 13 patients with severe pulmonary hypertension despite optimal medical management. However this single non-randomized study requires confirmation.
The investigators propose a prospective multi-center, randomized, single-blinded trial. Its main objective will be to assess, in patients with uncontrolled pulmonary hypertension despite optimal medical management, the efficacy of pulmonary artery denervation in reducing mean pulmonary artery pressure (mPAP) at six months, compared to continued medical treatment following a simulated (sham) procedure.
Read more
The principal evaluation criteria will be the mPAP change (in mm Hg) as measured by right heart catheterization.
The study will run for 18 months and it will be necessary to recruit 50 patients.
All adult patients (with the exception of pregnant women and individuals unable to receive an appropriate information and to give their free and informed consent) with uncontrolled pulmonary arterial hypertension despite optimal medical management will be invited to participate, in the absence of any exclusion criteria.
The investigators will also measure changes in clinical, biological, echocardiographic and hemodynamic prognostic markers in both groups.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- denervation, sham procedure
- 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.
denervationProcedure or surgery
The examination proceeds under rigorous aseptic technique. Femoral, jugular or brachial venous access will be performed. A flexible catheter is first introduced across a 7-Fr venous introducer, and passed through the right heart chambers toward the origin of the pulmonary arteries. The pressures in the right heart chambers and the pulmonary artery will be measured. At the end of the examination, the catheter is removed, a dressing is applied and the venous puncture is compressed by hand.
sham procedureProcedure or surgery
Right heart catheterism is mandatory in PAH patients care (for diagnosis and during follow-up) and will serve as a " sham " procedure. A usually performed and after a venous punction, cardiac outpout and pulmonary artery pressures will be recorded.
Acoustically isolated headphones will be given to patients during the procedure in order to assure simple-blind during the study.
| Study group | Role | What they receive |
|---|---|---|
| denervation | Experimental | Not described Receives: Procedure: denervation |
| control group | Sham comparator | Not described Receives: Procedure: sham procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean pulmonary artery pressure (in mmHg) measured during right heart catheterization
Measured: at 6 month
Secondary outcomes (11)
Mean pulmonary artery pressure (in mmHg) from the initial procedure
Measured: at 3 month
Pulmonary vascular resistance (in Wood units) measured during right cardiac catheterization.
Measured: at 6 month
Clinical parameters: NYHA class
Measured: at 6 month
Clinical parameters: Borg dyspnea rating scale
Measured: at 6 month
Clinical parameters: 6-minute walk test (distance walked in meters),
Measured: at 6 month
Clinical parameters: oxygen dependence (quantity of oxygen in L/min),
Measured: at 6 month
Clinical parameters: ECG with supra ventricular arrhythmia.
Measured: at 6 month
Biological parameters: levels of Brain Natriuretic Peptide (pg/ml) in non-fasting morning samples.
Measured: at 6 month
Biological parameters: levels of troponin Ic (ng/ml) in non-fasting morning samples.
Measured: at 6 month
Echocardiographic parameters of right ventricular function
- Right ventricular diameter at admission (mm) in 4-chamber view
- Right ventricular systolic function: tricuspid annular plane systolic excursion (TAPSE) (mm), peak S-wave velocity at the lateral tricuspid ring (cm/s), Right ventricular fractional area change (%), acceleration (m/s2) and peak isovolumic contraction (cm/s), pulmonary systolic time velocity integral (cm), longitudinal deformation of right ventricular free wall using speckle-tracking imaging (%)
- Right ventricular adaptation: right ventricular Tei-index and presence of pericardial effusion
Measured: at 6 month
Other hemodynamic parameters obtained by right cardiac catheterization
- Cardiac index/output using thermodilution (L/min/m2)
- Right atrial pressure (mmHg)
Measured: at 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study start4 Feb 2016
- Primary completion6 Dec 2022
- Study completion17 Oct 2024
Why it stopped: Refusal of CPP to extend the period of inclusion
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 Centre Hospitalier Universitaire de NiceThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique Hopitaux De Marseille, University Hospital, Toulouse, University Hospital, Grenoble, Assistance Publique - Hôpitaux de Paris
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02525926
- Sponsor's protocol ID
- 14-APN-02
- Acronym
- DENERV'AP
- Status last verified
- Oct 2024
- First submitted
- 3 Jul 2015
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Artery Denervation for Treatment of Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT02525926
- Acronym / sponsor ID
- DENERV'AP / 14-APN-02
- Conditions
- Pulmonary Arterial Hypertension
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Refusal of CPP to extend the period of inclusion
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Collaborators
- Assistance Publique Hopitaux De Marseille, University Hospital, Toulouse, University Hospital, Grenoble, Assistance Publique - Hôpitaux de Paris
- Study start
- 4 Feb 2016 (actual)
- Primary completion
- 6 Dec 2022 (actual)
- Study completion
- 17 Oct 2024 (actual)
- First posted
- 18 Aug 2015 (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 hypertension is a rare condition that leads to right ventricular dysfunction and premature death. Only modest improvements of outcomes have been observed with the current available advanced specific drug therapy. Pulmonary hypertension advanced therapy is also expensive and leads to frequent adverse effects, sometimes serious. Results from a pilot study, the first-in-man experience of pulmonary artery denervation, demonstrated a clinical improvement in 13 patients with severe pulmonary hypertension despite optimal medical management. However this single non-randomized study requires confirmation.
The investigators propose a prospective multi-center, randomized, single-blinded trial. Its main objective will be to assess, in patients with uncontrolled pulmonary hypertension despite optimal medical management, the efficacy of pulmonary artery denervation in reducing mean pulmonary artery pressure (mPAP) at six months, compared to continued medical treatment following a simulated (sham) procedure.
The principal evaluation criteria will be the mPAP change (in mm Hg) as measured by right heart catheterization.
The study will run for 18 months and it will be necessary to recruit 50 patients.
All adult patients (with the exception of pregnant women and individuals unable to receive an appropriate information and to give their free and informed consent) with uncontrolled pulmonary arterial hypertension despite optimal medical management will be invited to participate, in the absence of any exclusion criteria.
The investigators will also measure changes in clinical, biological, echocardiographic and hemodynamic prognostic markers in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| denervation | Experimental | Procedure: denervation |
| control group | Sham comparator | Procedure: sham procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with pulmonary artery hypertension (group 1 of the Nice classification of pulmonary hypertension)
Key exclusion criteria (5 listed)
- Patient eligible for pulmonary transplantation
- Pregnancy or breastfeeding
- Adults of the age of majority subject to guardianship court order or deprived of liberty
- Patient with history of radio frequency procedure
- Known heparin allergy
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 |
|---|---|---|
| denervationThe examination proceeds under rigorous aseptic technique. Femoral, jugular or brachial venous access will be performed. A flexible catheter is first introduced across a 7-Fr venous introducer, and passed through the right heart chambers toward the origin of the pulmonary arteries. The pressures in the right heart chambers and the pulmonary artery will be measured. At the end of the examination, the catheter is removed, a dressing is applied and the venous puncture is compressed by hand. | Procedure or surgery | denervation |
| sham procedureRight heart catheterism is mandatory in PAH patients care (for diagnosis and during follow-up) and will serve as a " sham " procedure. A usually performed and after a venous punction, cardiac outpout and pulmonary artery pressures will be recorded. Acoustically isolated headphones will be given to patients during the procedure in order to assure simple-blind during the study. | Procedure or surgery | control group |
Primary outcome
Mean pulmonary artery pressure (in mmHg) measured during right heart catheterization
Time frame: at 6 month
11 secondary outcomes
Mean pulmonary artery pressure (in mmHg) from the initial procedure
Time frame: at 3 month
Pulmonary vascular resistance (in Wood units) measured during right cardiac catheterization.
Time frame: at 6 month
Clinical parameters: NYHA class
Time frame: at 6 month
Clinical parameters: Borg dyspnea rating scale
Time frame: at 6 month
Clinical parameters: 6-minute walk test (distance walked in meters),
Time frame: at 6 month
Clinical parameters: oxygen dependence (quantity of oxygen in L/min),
Time frame: at 6 month
Clinical parameters: ECG with supra ventricular arrhythmia.
Time frame: at 6 month
Biological parameters: levels of Brain Natriuretic Peptide (pg/ml) in non-fasting morning samples.
Time frame: at 6 month
Biological parameters: levels of troponin Ic (ng/ml) in non-fasting morning samples.
Time frame: at 6 month
Echocardiographic parameters of right ventricular function
Time frame: at 6 month
Other hemodynamic parameters obtained by right cardiac catheterization
Time frame: at 6 month
Results and safety
The study was stopped early (reason given: Refusal of CPP to extend the period of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing denervation in people with Pulmonary Arterial Hypertension, run by Centre Hospitalier Universitaire de Nice at 5 sites 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 9 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: stopped early, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: Refusal of CPP to extend the period of inclusion). Results are not available in the source record.
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?
Mean pulmonary artery pressure (in mmHg) measured during right heart catheterization (time frame: at 6 month). 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 Oct 2024.