Pulmonary Artery Denervation for Treatment of Pulmonary Arterial Hypertension

NCT02525926 | Terminated

• 1 other identifier: 14-APN-02
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (1)

• Mean pulmonary artery pressure (in mmHg) measured during right heart catheterization

  at 6 month

Secondary Outcomes (11)

• Mean pulmonary artery pressure (in mmHg) from the initial procedure

  at 3 month

• Pulmonary vascular resistance (in Wood units) measured during right cardiac catheterization.

  at 6 month

• Clinical parameters: NYHA class

  at 6 month

• Clinical parameters: Borg dyspnea rating scale

  at 6 month

• Clinical parameters: 6-minute walk test (distance walked in meters),

  at 6 month

Study Arms (2)

denervation

EXPERIMENTAL

Procedure: denervation

control group

SHAM COMPARATOR

Procedure: sham procedure

Interventions

denervation 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.

denervation

sham procedure 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.

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead
• Assistance Publique Hopitaux De Marseille: collaborator
• University Hospital, Toulouse: collaborator
• University Hospital, Grenoble: collaborator
• Assistance Publique - Hôpitaux de Paris: collaborator

Study Sites (5)

CHU de Grenoble

Grenoble, 38700, France

Location

AP-HM

Marseille, 13354, France

Location

CHU de Nice

Nice, 06000, France

Location

AP-HP

Paris, 75015, France

Location

CHU de Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Denervation

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Neurosurgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2015
• First Posted: August 18, 2015
• Study Start: February 4, 2016
• Primary Completion: December 6, 2022
• Study Completion: October 17, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)