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Clinical Trials/NCT03954574
NCT03954574
Recruiting
N/A

Pulmonary Hemodynamics During Exercise - Research Network

Medical University of Graz32 sites in 14 countries1,500 target enrollmentDecember 1, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pulmonary Circulation Diseases
Sponsor
Medical University of Graz
Enrollment
1500
Locations
32
Primary Endpoint
Number of Participants who die during observation
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The purpose of this Clinical Research Collaboration is to investigate the prognostic implications of pulmonary hemodynamics during exercise based on a large scale multi-centre approach by using retrospective and prospective analysis of hemodynamic data.

Registry
clinicaltrials.gov
Start Date
December 1, 2018
End Date
December 31, 2029
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Medical University of Graz
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients (females and males; age: above 18yrs) with intermediate or high echocardiographic probability of PH and/or unexplained dyspnea, and/or associated conditions for PAH as clinical indication for RHC at rest and exercise
  • Written informed consent of participating subjects after being fully briefed (for prospective analysis)

Exclusion Criteria

  • Patients with incomplete hemodynamic data at rest or exercise
  • Patients without sufficient follow-up data (information on survival / lung transplantation)
  • advanced tumour disease or other diseases with a short life expectancy, except pulmonary vascular diseases
  • advanced heart failure with pulmonary arterial wedge pressure (PAWP) \> 18 mmHg at rest
  • uncontrolled systemic arterial hypertension (RR values \> 160/100 mmHg at rest)
  • FEV1\<50% predicted
  • TLC\<60% predicted

Outcomes

Primary Outcomes

Number of Participants who die during observation

Time Frame: 6 years

The investigators aim to assess the prognostic relevance of pulmonary hemodynamics during exercise as assessed by right heart catheterization by using a multi-centre approach and to identify independent predictors of adverse events. Separate data sets will be analysed for the retrospective and prospective Evaluation.

Number of Participants undergoing lung Transplantation during observation

Time Frame: 6 years

Occurrences of lung transplantations

Secondary Outcomes

  • Number of Participants being hospitalized during observation(6 years)
  • Number of Participants who develop pulmonary Hypertension as assessed by right heart catheterization(6 years)
  • Number of Participants with newly initiated pulmonary arterial Hypertension medication during observation(6 years)

Study Sites (32)

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