Predictors of Pulmonary Hypertension in Patients With Advanced Lung Diseases

NCT02777957 | Unknown

• 1 other identifier: SilesianCHD
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension

Keywords

Echocardiography; Lung Transplantation

Outcome Measures

Primary Outcomes (1)

• Survival after the initial right heart catheterization (RHC) measurements

  1 year

Secondary Outcomes (1)

• Survival to lung transplantation or the end of the observation period after the initial right heart catheterization (RHC) measurement

  3 years

Study Arms (2)

mPAP ≥ 25 mmHg

mean pulmonary artery pressure (mPAP) ≥ 25 mmHg (37 patients)

mPAP < 25 mmHg

mean pulmonary artery pressure (mPAP) \< 25 mmHg (28 patients).

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Silesian Centre for Heart Diseases: lead

Study Sites (1)

Silesian Centre for Heart Diseases

Zabrze, Silesian Voivodeship, 41-800, Poland

Location

Related Publications (1)

• 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.

  PMID: 28052583 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jolanta Nowak, MD, PhD

  3rd Department of Cardiology, Silesian Centre for Heart Diseases

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: May 19, 2016
• Study Start: December 1, 2008
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2023
• Last Updated: May 27, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)