Pulmonary Hemodynamics During Exercise - Research Network

Recruiting

• Conditions: Pulmonary Circulation Diseases

• Registration Number: NCT03954574
• Lead Sponsor: Medical University of Graz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-01
• Study First Submitted: 2019-03-14
• Study First Submitted QC: 2019-05-16
• Study First Posted: 2019-05-17
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-27
• Primary Completion: 2029-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants who die during observation	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	6 years	Occurrences of lung transplantations

Secondary Outcome Measures

Name	Time	Method
Number of Participants being hospitalized during observation	6 years	Number of hospitalizations
Number of Participants who develop pulmonary Hypertension as assessed by right heart catheterization	6 years	Diagnosis of pulmonary hypertension
Number of Participants with newly initiated pulmonary arterial Hypertension medication during observation	6 years	Evaluation of medication initiations

Trial Locations

Locations (32)

University of Arizona, Banner University Medical Center; 🇺🇸 Phoenix, Arizona, United States

University of California, Los Angeles, Lung & Heart-Lung Transplant and Pulmonary Hypertension Programs, David Geffen School of Medicine; 🇺🇸 Los Angeles, California, United States

Johns Hopkins Hospital, Advanced HF, MCS, Transplant Cardiology, Baltimore, Maryland, USA; 🇺🇸 Baltimore, Maryland, United States

Massachusetts General Hospital, Cardiology Division and Pulmonary Unit; 🇺🇸 Boston, Massachusetts, United States

Harvard Medical School, Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Minnesota Medical School, Division of Cardiology, Department of Medicine, Lillehei Heart Institute Minneapolis, Minnesota, USA; 🇺🇸 Minneapolis, Minnesota, United States

Mayo Clinic, Division of Cardiovascular Diseases, Department of Medicine; 🇺🇸 Rochester, Minnesota, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Royal Prince Alfred Hospital, Respiratory Medicine; 🇦🇺 Camperdown, Australia

Medical University of Graz; 🇦🇹 Graz, Austria

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