Pulmonary Artery Denervation for Treatment of Pulmonary Arterial Hypertension

NCT ID: NCT02525926

Last Updated: 2024-10-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-04
• Study Completion Date: 2024-10-17

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.

Conditions

Pulmonary Arterial Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

denervation

Group Type: EXPERIMENTAL

denervation

Intervention Type: PROCEDURE

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.

control group

Group Type: SHAM_COMPARATOR

sham procedure

Intervention Type: PROCEDURE

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.

Interventions

denervation

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.

Intervention Type: PROCEDURE

sham procedure

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: collaborator

University Hospital, Toulouse

OTHER

Sponsor Role: collaborator

University Hospital, Grenoble

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Grenoble

Grenoble, , France

AP-HM

Marseille, , France

CHU de Nice

Nice, , France

AP-HP

Paris, , France

CHU de Toulouse

Toulouse, , France

Countries

France

Other Identifiers

14-APN-02

Identifier Type: -

Identifier Source: org_study_id