Clinical trial NCT02777957: Predictors of Pulmonary Hypertension in Patients With Advanced Lung Diseases
Official title: Predictors and Survival in Pulmonary Hypertension Associated With Severe Lung Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Hypertension
Keywords: Echocardiography
Lung Transplantation
Lead sponsor: Silesian Centre for Heart Diseases
Sponsor class: OTHER
First posted: 2016-05-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Survival after the initial right heart catheterization (RHC) measurements
timeFrame: 1 year
Secondary outcomes:
measure: Survival to lung transplantation or the end of the observation period after the initial right heart catheterization (RHC) measurement
timeFrame: 3 years
Other outcomes:
Locations:
city: Zabrze
country: Poland
facility: Silesian Centre for Heart Diseases
state: Silesia
Study officials:
affiliation: 3rd Department of Cardiology, Silesian Centre for Heart Diseases
name: Jolanta Nowak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: 3rd Department of Cardiology, Silesian Centre for Heart Diseases
name: Mariusz Gasior, Prof., PhD
role: STUDY_CHAIR
affiliation: Departament of Cardiac Surgery and Transplantology, Silesian Centre for Heart Diseases
name: Slawomir Zeglen, MD, PhD
role: STUDY_CHAIR
affiliation: Departament of Cardiac Surgery and Transplantology, Silesian Centre for Heart Diseases
name: Jacek Wojarski, MD, PhD
role: STUDY_CHAIR
References:
citation: Nowak J, Hudzik B, Jastrzebski D, Niedziela JT, Rozentryt P, Wojarski J, Ochman M, Karolak W, Zeglen S, Gierlotka M, Gasior M. Pulmonary hypertension in advanced lung diseases: Echocardiography as an important part of patient evaluation for lung transplantation. Clin Respir J. 2018 Mar;12(3):930-938. doi: 10.1111/crj.12608. Epub 2017 Jan 12.