NCT03030807

Brief Summary

The investigation serves the identification of pulmonary hypertension (PH) among patients with hypersensitivity pneumonitis (HP). The exact prevalence of PH in HP is unknown. Data from South America indicate that the prevalence of pre-capillary PH amongst patients with HP is higher than 20%. There are no reliable data from Europe so far. According to the investigators previous analysis, more than 400 HP patients have participated in pulmonary rehabilitation at least once in the past 10 years at Klinikum Bad Gleichenberg (Rehabilitation Center for Agricultural Workers in Austria). This collective of patients is to be invited to participate in the study. A diagnostic algorithm will be applied in the clinical trial, in the case of clinical suspicion the diagnosis of PH will be confirmed by right heart catheterization. Besides the determination of the prevalence of PH in patients with HP the investigators aim to assess the reliability of non-invasive methods (e.g. Echocardiography, ECG...) to predict PH.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
426

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Longer than P75 for all trials

Status
completed

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

October 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

November 19, 2020

Status Verified

November 1, 2020

Enrollment Period

4.1 years

First QC Date

January 23, 2017

Last Update Submit

November 17, 2020

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

  • Prevalence of pulmonary hypertension

    4 year

Interventions

Right heart catheterization (in case of suspected PH)DIAGNOSTIC_TEST

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with confirmed Hypersensitivity Pneumonitis

You may qualify if:

  • Patients with confirmed Hypersensitivity Pneumonitis
  • written consent
  • Age: 18-90 years

You may not qualify if:

  • severe impairment of the general health condition
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Horst Olschewski, MD

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2017

First Posted

January 25, 2017

Study Start

October 1, 2016

Primary Completion

October 31, 2020

Study Completion

October 31, 2020

Last Updated

November 19, 2020

Record last verified: 2020-11