Recruiting

Observational Study

Sponsor:

Medical University of Graz

Code:

NCT03954574

Conditions

Pulmonary Circulation Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

assessment of pulmonary hemodynamics during exercise by right heart catheterization

Study Details

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.

Conditions

Pulmonary Circulation Diseases

Study ID

NCT03954574

Start date

Dec 1, 2018

Status verified date

Apr, 2025

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Arms

Retrospective patient cohort

Prospective patient cohort

Interventions

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

Primary outcome measure

  • Number of Participants who die during observation [ Time Frame: 6 years ]
  • Number of Participants undergoing lung Transplantation during observation [ Time Frame: 6 years ]

Central Contacts and Locations

Central contacts

Gabor Kovacs, MD

+43-316-385gabor.kovacs@klinikum-graz.at

Locations

University of Arizona, Banner University Medical Center

Recruiting

Phoenix, Arizona, United States, 85724

Contacts

Rajeev Saggar

rsaggar@gmail.com

University of California, Los Angeles, Lung & Heart-Lung Transplant and Pulmonary Hypertension Programs, David Geffen School of Medicine

Recruiting

Los Angeles, California, United States, 90095

Contacts

Rajan Saggar

rsaggar@mednet.ucla.edu

Johns Hopkins Hospital, Advanced HF, MCS, Transplant Cardiology, Baltimore, Maryland, USA

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Steven Hsu

steven.hsu@jhmi.edu

Massachusetts General Hospital, Cardiology Division and Pulmonary Unit

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Gregory Lewis

glewis@partners.org

Bradley A. Maron

bmaron@partners.org

Harvard Medical School, Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02138

Contacts

David Systrom

dsystrom@bwh.harvard.edu

University of Minnesota Medical School, Division of Cardiology, Department of Medicine, Lillehei Heart Institute Minneapolis, Minnesota, USA

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Thenappan Thenappan

tthenapp@umn.edu

Mayo Clinic, Division of Cardiovascular Diseases, Department of Medicine

Recruiting

Rochester, Minnesota, United States, 85259

Contacts

Barry Borlaug

Borlaug.barry@mayo.edu

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Ryan Tedford

tedfordr@musc.edu

More Information

Sponsor

Medical University of Graz

Last update posted

Apr 27, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Medical University of Graz on 2025-04-27.