NCT02403908

Brief Summary

The aim of research proposal is to assess and compare the safety and efficacy of radiofrequency denervation of pulmonary arteries on decrease in pulmonary vascular resistance and mean pulmonary artery pressure (MPAP) in 20 patients with IPAH (mean pulmonary artery pressure \>25 mmHg) and in 20 patients with secondary pulmonary hypertension due to pulmonary disease or due to left heart disease not responding optimally to medical therapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2015

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 11, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

March 31, 2015

Status Verified

March 1, 2015

Enrollment Period

11 months

First QC Date

March 11, 2015

Last Update Submit

March 25, 2015

Conditions

Hypertension, Pulmonary

Keywords

radiofrequency denervation, pulmonary hypertension

Outcome Measures

Primary Outcomes (3)

  • decrease in mean PAP

    immeditely after PADN, and three and six months after PADN

  • decrease in pulmonary vascular resistance

    immeditely after PADN, and three and six months after PADN

  • improvement of functional capacity by the 6MWT.

    48 hours after PADN, and three and six months after PADN

Secondary Outcomes (1)

  • Major clinical adverse events (MACE) including PA perforation/dissection, acute thrombus formation in the PA, all-cause death, MI, stroke

    immediately after PADN, and three and six months after PADN

Study Arms (2)

PADN groups (radiofrequency denervation)

EXPERIMENTAL

An 8-F long sheath will be inserted through the femoral vein and advanced to the main PA (MPA). The nMARQ Circular or Crescent (Biosense Webster) catheter will be advanced along this long sheath. After gently withdrawing the sheath and pushing the PADN catheter, the tip will be released from the sheath. Then, the tip of the catheter will be positioned first at the ostium of the left PA (Level 1 of ablation, \<2 mm distal to orifice. After ablation at this level, the catheter tip will be positioned at the ostium of right PA (Level 2 of ablation, \<2mm proximal to the bifurcation level). Finally, denervation of main pulmonary artery will be done by pulling the denervation catheter back into Level 3 of ablation (\<2 mm proximal to both ostia of right and left PA-s) into main pulmonary artery.

Device: nMARQ Circular and Crescent catheters

SHAM group

NO INTERVENTION

non-treated patients (controls)

Interventions

nMARQ Circular and Crescent cathetersDEVICE

Radiofrequency denervation of right and left pulmonary arteries ostia and of main pulmonary artery \<2 mm proximal from both ostia of right and left pulmonary arteries.

Also known as: Radiofrequency denervation
PADN groups (radiofrequency denervation)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital centre Zagreb

Zagreb, Croatia

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Central Study Contacts

Aleksander Ernst, M.D., PH.D.

CONTACT

aleksanderernst@gmail.com

Mladen Vidovich, M.D., Ph.D.

CONTACT

miv@uic.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor if Internal Medicine & Cardiology

Study Record Dates

First Submitted

March 11, 2015

First Posted

March 31, 2015

Study Start

February 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2019

Last Updated

March 31, 2015

Record last verified: 2015-03

Locations

CR(1)