Predictors of Pulmonary Hypertension in Patients With Advanced Lung Diseases

May 25, 2020 updated by: Jolanta Nowak, Silesian Centre for Heart Diseases

Predictors and Survival in Pulmonary Hypertension Associated With Severe Lung Disease

First, the aim of the study was to evaluate the usefulness of echocardiographic parameters for detecting pulmonary hypertension (PH) in patients with advanced lung disease referred for lung transplantation. Second, to assess the prevalence of PH and to identify which hemodynamic, echocardiographic, pulmonary functional test, exercise capacity and biochemical parameters (especially NT-proBNP) have an impact on survival in a cohort of patients with severe lung diseases referred for lung transplantation.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Silesia
      • Zabrze, Silesia, Poland, 41-800
        • Silesian Centre for Heart Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients with advanced lung diseases referred for lung transplantation. All patients underwent examinations as potential candidates for lung transplantation, including laboratory testing, pulmonary function tests, exercise capacity, echocardiography examination, and right heart catheterization. Evaluation for lung transplantation was performed during clinically stable periods in all patients on optimal medical and oxygen therapy.

Description

Inclusion Criteria:

  • advanced lung disease
  • qualification for lung transplantation
  • written informed consent
  • pulmonary capillary wedge pressure < 15 mmHg

Exclusion Criteria:

  • cancer,
  • history of idiopathic pulmonary hypertension,
  • primary valvular heart diseases,
  • coronary artery disease,
  • collagen vascular disease,
  • history or evidence of left ventricular dysfunction,
  • atrial fibrillation,
  • increased liver enzyme levels ( 3 times the upper laboratory limit),
  • renal dysfunction (estimated glomerular filtration rate < 60 ml/min/1.73m2)
  • patients who didn't write the personal informed consent
  • any specific therapy for PH.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
mPAP ≥ 25 mmHg
mean pulmonary artery pressure (mPAP) ≥ 25 mmHg (37 patients)
mPAP < 25 mmHg
mean pulmonary artery pressure (mPAP) < 25 mmHg (28 patients).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival after the initial right heart catheterization (RHC) measurements
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Survival to lung transplantation or the end of the observation period after the initial right heart catheterization (RHC) measurement
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Silesian Centre for Heart Diseases

Investigators

  • Principal Investigator: Jolanta Nowak, MD, PhD, 3rd Department of Cardiology, Silesian Centre for Heart Diseases
  • Study Chair: Mariusz Gasior, Prof., PhD, 3rd Department of Cardiology, Silesian Centre for Heart Diseases
  • Study Chair: Slawomir Zeglen, MD, PhD, Departament of Cardiac Surgery and Transplantology, Silesian Centre for Heart Diseases
  • Study Chair: Jacek Wojarski, MD, PhD, Departament of Cardiac Surgery and Transplantology, Silesian Centre for Heart Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

April 1, 2020

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

May 18, 2016

First Submitted That Met QC Criteria

May 18, 2016

First Posted (Estimate)

May 19, 2016

Study Record Updates

Last Update Posted (Actual)

May 27, 2020

Last Update Submitted That Met QC Criteria

May 25, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SilesianCHD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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