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Predictors of Pulmonary Hypertension in Patients With Advanced Lung Diseases

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ClinicalTrials.gov Identifier: NCT02777957
Recruitment Status : Recruiting
First Posted : May 19, 2016
Last Update Posted : May 19, 2016
Sponsor:
Information provided by (Responsible Party):
Jolanta Nowak, Silesian Centre for Heart Diseases

Brief Summary:
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.

Condition or disease
Pulmonary Hypertension

Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Predictors and Survival in Pulmonary Hypertension Associated With Severe Lung Disease
Study Start Date : December 2008
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


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).



Primary Outcome Measures :
  1. Survival after the initial right heart catheterization (RHC) measurements [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Survival to lung transplantation or the end of the observation period after the initial right heart catheterization (RHC) measurement [ Time Frame: 3 years ]

Biospecimen Retention:   Samples Without DNA
Blood samples


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02777957


Contacts
Contact: Jolanta Nowak, MD, PhD nowjola@wp.pl

Locations
Poland
Silesian Centre for Heart Diseases Recruiting
Zabrze, Silesia, Poland, 41-800
Contact: Jolanta Nowak, MD, PhD       nowjola@wp.pl   
Sponsors and Collaborators
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

Responsible Party: Jolanta Nowak, MD, PhD, Silesian Centre for Heart Diseases
ClinicalTrials.gov Identifier: NCT02777957     History of Changes
Other Study ID Numbers: SilesianCHD
First Posted: May 19, 2016    Key Record Dates
Last Update Posted: May 19, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jolanta Nowak, Silesian Centre for Heart Diseases:
Echocardiography
Lung Transplantation

Additional relevant MeSH terms:
Hypertension
Lung Diseases
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases