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Pulmonary Hemodynamics During Exercise - Research Network (PEX-NET)

M

Medical University of Graz

Status

Enrolling

Conditions

Pulmonary Circulation Diseases

Treatments

Diagnostic Test: assessment of pulmonary hemodynamics during exercise by right heart catheterization

Study type

Observational

Funder types

Other

Identifiers

NCT03954574
30-437 ex 17/18

Details and patient eligibility

About

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.

Enrollment

1,500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

1,500 participants in 2 patient groups

Retrospective patient cohort
Treatment:
Diagnostic Test: assessment of pulmonary hemodynamics during exercise by right heart catheterization
Prospective patient cohort
Treatment:
Diagnostic Test: assessment of pulmonary hemodynamics during exercise by right heart catheterization

Trial contacts and locations

32

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Central trial contact

Gabor Kovacs, MD

Data sourced from clinicaltrials.gov

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