Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04177251 |
Other study ID # |
1349/2019 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
October 21, 2019 |
Est. completion date |
October 15, 2022 |
Study information
Verified date |
October 2022 |
Source |
San Gerardo Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Fibroproliferative diseases, including pulmonary, cardiac and vascular fibrosis share common
pathogenetic mechanisms. Furthermore, cardiovascular comorbidities are frequently found in
patients with IPF. However, the prevalence of cardiac and vascular fibrosis in patients with
IPF have yet to be determined.
Main Purpose of this study is to evaluate, with non-invasive methods (echocardiogram,
endothelial function and pulse wave velocity) and blood biomarkers (galectins-3, osteopontin,
periostin and pro-BNP), the presence of vascular fibrosis (vascular rigidity and endothelial
function) and cardiac fibrosis (prevalence of HFpEF - Heart Failure with Preserved Ejection
Fraction) in patients with idiopathic pulmonary fibrosis (IPF), compared to healthy controls.
Description:
Fibroproliferative diseases are the cause of 45% of deaths in developed countries. A wide
range of diseases belongs to this category, including pulmonary fibrosis.
The fact that in some fibroproliferative diseases the fibrotic process may involve several
organs suggests the activation of common causative and pathophysiological mechanisms, which
involve inflammatory cells - in particular macrophages and T lymphocytes - epithelial and
endothelial cells and fibrogenesis effector cells (fibroblasts, myofibroblasts and
fibrocytes). Even in fibroproliferative diseases that apparently have no multiorgan
manifestations, such as idiopathic pulmonary fibrosis (IPF), idiopathic myelofibrosis and
cardiac fibrosis, common pathogenic pathways have already been studied and recognized (e.g.
metabolic pathway of the transforming growth factor-beta -TGF-β- and activation of the
transcription factor c-JUN which cause uncontrolled production of collagen fibers by
fibroblasts).
Furthermore, cardiovascular comorbidities are frequently found in patients with IPF,
particularly ischemic heart disease and arrhythmias. With regard to ischemic heart disease
the prevalence reported in patients with IPF is directly proportional to the high prevalence
of left ventricular diastolic dysfunction. However, the nature of the association between IPF
and ischemic heart disease as well as the prevalence of cardiac and vascular fibrosis in
patients with IPF have yet to be determined.
The primary purpose of our study is to evaluate, with non-invasive methods (echocardiogram,
endothelial function and pulse wave velocity) and blood biomarkers (galectins-3, osteopontin,
periostin and pro-BNP), the presence of vascular fibrosis (vascular rigidity and endothelial
function) and cardiac fibrosis (prevalence of HFpEF - Heart Failure with Preserved Ejection
Fraction) in patients with idiopathic pulmonary fibrosis (IPF), compared to the general
population.
Secondary purposes are the evaluation of the association between the presence and the degree
of pulmonary-cardiac-vascular fibrosis and the level of biomarkers analysed (pro-BNP,
galectins-3, osteopontin and periostin) and the evaluation of the association between the
presence / degree of vascular and / or cardiac fibrosis at baseline and disease progression
at 1 year from the diagnosis of IPF.
Explorative aim of the study is also to evaluate the association between the degree of
pulmonary fibrosis and the levels of blood proteomic and metabolomic biomarkers measured at
baseline only in IPF patients.
Study design: multicenter observational case-control study. For IPF patients, participation
in the study consists of two visits (T1, at IPF diagnosis, and T3, 1 year after T1) at the
IPF clinic where the patient is followed up, as per normal clinical practice. Clinical
history, arterial blood gas analysis and / or SpO2, pulmonary function tests and DLco and 6
minutes walking tests will be collected at T1 and T3. Blood samples for pro-BNP, galectin-n3,
osteopontin, periostin and proteomic / metabolomic analysis will be collected at T1. A
cardiological evaluation (T2), within 1 month of T1, will be performed in order to collect
cardiological clinical data and to perform the following non-invasive measurements:
echocardiogram, flow mediated dilation (FMD), pulse wave velocity (PWV).
For healthy volunteers the participation in the study consists of a baseline visit during
which cardiopulmonary physical examination, clinical data and blood samples for biomarkers
will be collected (T1). A cardiological examination with echocardiogram, FMD and PWV will
take place within 1 month from T1.