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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 April 2015 |
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Main ID: |
NCT02403908 |
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Date of registration:
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11/03/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Catheter Denervation of Pulmonary Arteries in Treatment of IPAH & SPAH
CADOPA |
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Scientific title:
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Catheter Denervation of Pulmonary Arteries in The Treatment of Idiopathic (PAH) & Secondary Pulmonary Hypertension (PH) |
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Date of first enrolment:
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February 2015 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02403908 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Croatia
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Contacts
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Name:
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Aleksander Ernst, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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aleksanderernst@gmail.com |
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Affiliation:
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Name:
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Aleksander Ernst, M.D., PH.D. |
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Address:
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Telephone:
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Email:
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aleksanderernst@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with IPAH and SPAH (defined as a mean PAP >25 mm Hg at rest) not responding
optimally to current medical therapy (defined as a reduction of <5mmHg in the resting
mean PAP during medication, or unchanged 6-min walk test (6MWT) defined as increment
of 6MW distance <50 m) will be eligible for the study.
Exclusion Criteria:
- Patients of age <18 years, patients with structural heart diseases with left-to right
shunting and/or with Eisenmenger syndrome will be excluded from the trial.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypertension, Pulmonary
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Intervention(s)
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Device: nMARQ Circular and Crescent catheters
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Primary Outcome(s)
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decrease in mean PAP
[Time Frame: immeditely after PADN, and three and six months after PADN]
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decrease in pulmonary vascular resistance
[Time Frame: immeditely after PADN, and three and six months after PADN]
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improvement of functional capacity by the 6MWT.
[Time Frame: 48 hours after PADN, and three and six months after PADN]
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Secondary Outcome(s)
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Major clinical adverse events (MACE) including PA perforation/dissection, acute thrombus formation in the PA, all-cause death, MI, stroke
[Time Frame: immediately after PADN, and three and six months after PADN]
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Secondary ID(s)
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HRZZ-2014 Project Number:2505
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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