NCT02959723

Brief Summary

The current aims to combine analysis of different inflammatory biomarkers and BMPR2 mutations, which are currently analyzed in each patient diagnosed with idiopathic or familial PAH, to establish an earlier diagnosis and consequently better orientate the therapeutic strategy in PAH.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2015

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

November 9, 2016

Status Verified

November 1, 2016

Enrollment Period

2.9 years

First QC Date

April 23, 2015

Last Update Submit

November 8, 2016

Conditions

Idiopathic Pulmonary Arterial Hypertension

Keywords

Pulmonary Arterial HypertensionBMPR2Inflammation

Outcome Measures

Primary Outcomes (1)

  • Circulating Inflammatory Biomarkers: CRP, total cholesterol, HDL-cholesterol, triglycerides, albumin, Lp-PLA2 activity, Thrombin Activatable Fibrinolysis Inhibitor (TAFI), vitamin D

    Changes from baseline in circulating inflammatory biomarkers will be evaluated at 6 months, 12 months and 24 months whenever a right heart catheterization will be performed after starting a treatment

Eligibility Criteria

Age15 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Idiopathic Pulmonary Arterial Hypertension undergoing right heart catheterization and/or lung transplantation

You may qualify if:

  • Idiopathic Pulmonary Arterial Hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven Campus Gasthuisberg

Leuven, 3000, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Lung tissue

MeSH Terms

Conditions

Familial Primary Pulmonary HypertensionPulmonary Arterial HypertensionInflammation

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Data Manager

Study Record Dates

First Submitted

April 23, 2015

First Posted

November 9, 2016

Study Start

January 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2020

Last Updated

November 9, 2016

Record last verified: 2016-11

Locations

BE(1)