Overview

This trial is active, not recruiting.

Condition life change events
Treatments pulmonary arterial denervation (padn), sildenafil, bosentan, prostacyclin
Phase phase 1
Sponsor The First Affiliated Hospital with Nanjing Medical University
Start date December 2014
End date December 2016
Trial size 200 participants
Trial identifier NCT02284737, FirstNanjingMU

Summary

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 targets for PAH patients are not clear. We previously reported the safety and efficacy of pulmonary artery denervation (PADN) for treatment of PAH who were unresponsive to target drugs. However, there is a lack of a randomized study to identify the effect of PADN on PAH.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Active Comparator)
Patients in the drug treatment group will take one or combination of the following target drugs: Sildenafil, Bosentan and Prostacyclin. On the other hand, patients in the PADN group do not take any of the target drugs mentioned above.
sildenafil 5'-PDE
Patients in the drug treatment group will take their baseline anti-heart failure medications at the original doses, without any changes except when medically required.The anti-heart failure drugs treatment is consistent in both arms.Patients in the standard treatment group will take one or combination of the following target drugs: endothelin receptor antagonist, 5'-PDE and prostacyclin. On the other hand, patients in the PADN group do not take any of the target drugs mentioned above.
bosentan endothelin receptor antagonist
Patients in the standard treatment group will take their baseline anti-heart failure medications at the original doses, without any changes except when medically required.The anti-heart failure drugs treatment is consistent in both arms.Patients in the standard treatment group will take one or combination of the following target drugs: endothelin receptor antagonist, 5'-PDE and prostacyclin. On the other hand, patients in the PADN group do not take any of the target drugs mentioned above.
prostacyclin
Patients in the standard treatment group will take their baseline anti-heart failure medications at the original doses, without any changes except when medically required.The anti-heart failure drugs treatment is consistent in both arms.Patients in the standard treatment group will take one or combination of the following target drugs: endothelin receptor antagonist, 5'-PDE and prostacyclin. On the other hand, patients in the PADN group do not take any of the target drugs mentioned above.
(Experimental)
For PADN group (n=100), PADN is performed immediately after measurement of PA hemodynamics as in standard treatment group.
pulmonary arterial denervation (padn) PADN
Contrast pulmonary artery (PA) angiography was performed to localize the pulmonary artery bifurcation level and calculate the PA diameter.Once the anatomy was deemed acceptable, the radiofrequency ablation catheter was introduced into the distal bifurcation area of the main PA.This was then maneuvered within the PA to allow energy delivery to ensure that the electrodes were tightly in contact with the endovascular surface. About two to three ablations at 1-15 W for 240 seconds each point were performed in the distal bifurcation area of the main PA.

Primary Outcomes

Measure
Pulmonary artery hypertension (PAH)- related events
time frame: One-year

Secondary Outcomes

Measure
6-minute walk distance
time frame: One-year
Calculation of the total costs
time frame: in-hospital phase (up to 3 weeks)
Calculation of the total costs
time frame: 12 months

Eligibility Criteria

Male or female participants at least 12 years old.

Inclusion Criteria: - Idiopathic pulmonary hypertension (IPAH) - PAH secondary from connective tissue disease - Chronic thromboembolic pulmonary Hypertension (CTEPH) - PAH secondary from pulmonary interstitial fibrosis - "Reactive"Pulmonary Hypertension in Left Heart Failure: mPAP≥25 mmHg, PCWP>15 mmHg and pulmonary vascular resistance (PVR) [The PVR =(mPAP-PCWP)/ carbon monoxide]>2.5 woods unit - PAH secondary from congenital heart disease after surgical repair - PAH secondary from human immuno deficiency virus infection or from drug use or toxin exposure - Rest mean pulmonary arterial pressure >=25 mmHg by right heart catheterization (RHC) Exclusion Criteria: - Patients receiving intravenous treatment - Severe Renal dysfunction (Ccr<30 ml/min) - Blood platelet count<100,000/L - Expected life span<12-month - In pregnancy - Systematical inflammation - Malignant cancer(s) - Tricuspid valve stenosis, Supra-pulmonary valve stenosis - Allergic to studied drugs or metal materials

Additional Information

Official title Comparison of Pulmonary Artery Denervation and Medications for Treatment of Pulmonary Arterial Hypertension: a Multicenter, Randomized, Prospective PADN-PAH Trial
Principal investigator Shao-Liang Chen, MD
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 35% after 6-month treatment using target drugs. And our previous data showed that this PAH-related event at 6-month after PADN procedure was 20%. As a result, a total of 200 PAH patients was required, with 100 patients/per group at a ratio of 1:1 randomization.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by The First Affiliated Hospital with Nanjing Medical University.