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

Launched by NANJING FIRST HOSPITAL, NANJING MEDICAL UNIVERSITY · Nov 4, 2014

Keywords

ClinConnect Summary

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 ...

Gender

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Eligibility criteria

• 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.