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Pulmonary Artery Denervation for Treatment of Pulmonary Arterial Hypertension

Information source: The First Hospital of Nanjing Medical University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Life Change Events

Intervention: Pulmonary Arterial Denervation (PADN) (Procedure); Sildenafil (Drug); Bosentan (Drug); Prostacyclin (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: The First Hospital of Nanjing Medical University

Official(s) and/or principal investigator(s):
Shao-Liang Chen, MD, Principal Investigator, Affiliation: Nanjing First Hospital, Nanjing Medical University, China


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.

Clinical Details

Official title: Comparison of Pulmonary Artery Denervation and Medications for Treatment of Pulmonary Arterial Hypertension: a Multicenter, Randomized, Prospective PADN-PAH Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Pulmonary artery hypertension (PAH)- related events

Secondary outcome:

6-minute walk distance

Calculation of the total costs

Calculation of the total costs

Detailed 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.


Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.


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: mPAPā‰„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


- 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

Locations and Contacts

Nanjing First Hospital, Nanjing, Jiangsu 210006, China
Additional Information

Starting date: December 2014
Last updated: July 2, 2015

Page last updated: August 23, 2015

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