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
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.
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 distanceCalculation 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.
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
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
Locations and Contacts
Nanjing First Hospital, Nanjing, Jiangsu 210006, China
Additional Information
Starting date: December 2014
Last updated: July 2, 2015
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