Pulmonary Artery Denervation for Treatment of Pulmonary Arterial Hypertension (DENERV'AP)

Centre Hospitalier Universitaire de Nice

Status

Terminated

Conditions

Pulmonary Arterial Hypertension

Treatments

Procedure: denervation

Procedure: sham procedure

Study type

Interventional

Funder types

Other

Identifiers

NCT02525926

14-APN-02

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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