Predictors of Pulmonary Hypertension in Patients With Advanced Lung Diseases

Pulmonary Hypertension Clinical Trial

Official title:

Predictors and Survival in Pulmonary Hypertension Associated With Severe Lung Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02777957
• Other study ID #: SilesianCHD
• Status: Active, not recruiting
• Start date: December 2008
• Est. completion date: April 2023

Study information

• Verified date: May 2020
• Source: Silesian Centre for Heart Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: April 2023
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Lung Diseases
• Pulmonary Hypertension

Locations

Country	Name	City	State
Poland	Silesian Centre for Heart Diseases	Zabrze	Silesia

Sponsors (1)

Lead Sponsor	Collaborator
Silesian Centre for Heart Diseases

Country where clinical trial is conducted

Poland, 

References & Publications (1)

Nowak J, Hudzik B, Jastrz?bski 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival after the initial right heart catheterization (RHC) measurements		1 year
Secondary	Survival to lung transplantation or the end of the observation period after the initial right heart catheterization (RHC) measurement		3 years