Status:
TERMINATED
A Study to Investigate the Efficacy of PADN to Improved Functional Capacity and Hemodynamics in Patients With PAH
Lead Sponsor:
Nanjing First Hospital, Nanjing Medical University
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 significan...
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 hyp...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 28 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02284737
Start Date
November 28 2014
End Date
July 30 2021
Last Update
February 20 2024
Active Locations (1)
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1
Nanjing First Hospital
Nanjing, Jiangsu, China, 210006