A Study to Investigate the Efficacy of PADN to Improved Functional Capacity and Hemodynamics in Patients With PAH (PADN-PAH)

Nanjing Medical University

Status and phase: Terminated; Phase 4

Conditions: Pulmonary Arterial Hypertension

Treatments: Procedure: PADN; Procedure: sham PADN; Drug: Sildenafil

Study type: Interventional

Funder types: Other

Identifiers

NCT02284737

FirstNanjingMU

Details and patient eligibility

About

Pulmonary arterial hypertension (PAH) is characterized by premature death mainly because of progressive and severe right ventricular failure. Target drugs are reported to be associated with significant improvement of clinical outcome for PAH patients. However, previous studies using those target drugs focused on the change of 6-minute walk distance (6MWD) and or hemodynamic responses. As 6MWD has weak correlation with clinical outcome (time to clinical worsening, TTCW), benefits from target drugs for PAH patients are not clear. We previously reported the safety and efficacy of pulmonary artery denervation (PADN) for treatment of PAH patients who were unresponsive to target drugs. Hence, we design the randomized study to identify the effect of PADN on PAH.

Full description

The current study is designed as a multicenter, randomized and prospective study aiming to compare the effect of PADN on PAH patients. Based on the previous studies, the rate of pulmonary arterial hypertension (PAH)-related event was around 30% after 6-month treatment using target drugs. And our previous data showed that this PAH-related event at 6-month after PADN procedure was 15%. As a result, a total of 270 PAH patients was required, with 135 patients/per group at a ratio of 1:1 randomization. All patients underwent an 18F-DOPA PET/CT scan of pulmonary arteries and the heart, performed at basement.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of informed consent prior to any study specific procedures;
• Men and women 18 years and older;
• Group I PAH, defined as a mPAP≥25mmHg, PCWP<15mmHg and PVR[The PVR =(mPAP-PCWP)/CO]>3.0 Woods unit.

Exclusion criteria

General exclusion criteria:

• Pregnancy and breast feeding mother;
• Estimated life expectancy <12 months;
• Scheduled major surgery in the next 6 months;
• Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk;
• Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 30 days.

Procedural exclusion criteria:

• WHO group II, III, IV, V PH
• Severe Renal dysfunction (Ccr<30 ml/min)
• Blood platelet count<100,000/L
• Expected life span<6-month
• Systematical inflammation
• Malignant cancer(s)
• Tricuspid valve stenosis, Supra-pulmonary valve stenosis
• Allergic to studied drugs or metal materials.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

PADN + sildenafil

Experimental group

Description:

Two to three ablations at 1-15 W for 120 seconds at each point were performed in the distal bifurcation area of the main PA.

Treatment:

Drug: Sildenafil

Procedure: PADN

sham PADN + sildenafil

Sham Comparator group

Description:

The radiofrequency ablation catheter placed, no ablations.

Treatment:

Drug: Sildenafil

Procedure: sham PADN