Clinical trial NCT02525926: Pulmonary Artery Denervation for Treatment of Pulmonary Arterial Hypertension
Official title: Pulmonary Artery Denervation for Treatment of Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
Collaborators: name: Assistance Publique Hopitaux De Marseille
name: University Hospital, Toulouse
name: University Hospital, Grenoble
name: Assistance Publique - Hôpitaux de Paris
First posted: 2015-08-18
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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
  * 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mean pulmonary artery pressure (in mmHg) measured during right heart catheterization
timeFrame: at 6 month
Secondary outcomes:
measure: Mean pulmonary artery pressure (in mmHg) from the initial procedure
timeFrame: at 3 month
measure: Pulmonary vascular resistance (in Wood units) measured during right cardiac catheterization.
timeFrame: at 6 month
measure: Clinical parameters: NYHA class
timeFrame: at 6 month
measure: Clinical parameters: Borg dyspnea rating scale
timeFrame: at 6 month
measure: Clinical parameters: 6-minute walk test (distance walked in meters),
timeFrame: at 6 month
measure: Clinical parameters: oxygen dependence (quantity of oxygen in L/min),
timeFrame: at 6 month
measure: Clinical parameters: ECG with supra ventricular arrhythmia.
timeFrame: at 6 month
measure: Biological parameters: levels of Brain Natriuretic Peptide (pg/ml) in non-fasting morning samples.
timeFrame: at 6 month
measure: Biological parameters: levels of troponin Ic (ng/ml) in non-fasting morning samples.
timeFrame: at 6 month
measure: Echocardiographic parameters of right ventricular function
timeFrame: at 6 month
measure: Other hemodynamic parameters obtained by right cardiac catheterization
timeFrame: at 6 month
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU de Grenoble
city: Marseille
country: France
facility: AP-HM
city: Nice
country: France
facility: CHU de Nice
city: Toulouse
country: France
facility: CHU de Toulouse
city: ¨Paris
country: France
facility: AP-HP
Study officials:
References: