Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Retrospective patient cohort
  • Diagnostic Test: assessment of pulmonary hemodynamics during exercise by right heart catheterization
    all patients undergo right heart catheterization during exercise due to clinical reasons. Results of this and other Routine clinical tests will be included in the registry
Prospective patient cohort
  • Diagnostic Test: assessment of pulmonary hemodynamics during exercise by right heart catheterization
    all patients undergo right heart catheterization during exercise due to clinical reasons. Results of this and other Routine clinical tests will be included in the registry

Recruiting Locations

Massachusetts General Hospital, Cardiology Division and Pulmonary Unit
Boston, Massachusetts 02114
Contact:
Gregory Lewis
glewis@partners.org

More Details

NCT ID
NCT03954574
Status
Recruiting
Sponsor
Medical University of Graz

Study Contact

Gabor Kovacs, MD
+43-316-385
gabor.kovacs@klinikum-graz.at

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.