Cardiovascular Fibrosis in Idiopathic Pulmonary Fibrosis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 40 Years and Over
Gender All
More Inclusion & Exclusion Criteria

For IPF patients:

Inclusion Criteria:

  • - diagnosis of idiopathic pulmonary fibrosis according to the 2011 ATS / ERS guidelines with Multidisciplinary discussion; - informed consent signed and obtained before study enrollment.

Exclusion Criteria:

  • - having already received (currently or in the past) therapy with pirfenidone or nintedanib; - participation in other experimental interventional protocols with medicinal use; - need for oxygen therapy at rest; - active smoking; - presence of atrial fibrillation or atrial flutter; - amputation of a limb or severe peripheral vasculopathy (defined as the presence of previous stenting or vascular surgery of the lower limbs or as the presence of claudication with onset of symptoms for intervals <700 m).
For healthy volunteers:

Inclusion Criteria:

  • - informed consent signed and obtained before study enrollment.

Exclusion Criteria:

  • - active smoking; - presence of atrial fibrillation or atrial flutter; - amputation of a limb or severe peripheral vasculopathy (defined as the presence of previous stenting or vascular surgery of the lower limbs or as the presence of claudication with onset of symptoms for intervals <700 m); - diagnostic suspicion of IPF at baseline (T1); - participation in other experimental protocols.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04177251
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

San Gerardo Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Paola Faverio, MD
Principal Investigator Affiliation Università degli Studi di Milano Bicocca - Ospedale San Gerardo
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Italy
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis, Cardiac Fibrosis, Arterial Fibrosis
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Monza, MB, Italy

Status

Recruiting

Address

Ospedale San Gerardo Monza - Università Milano Bicocca

Monza, MB, 20900

Site Contact

Paola Faverio, MD

paola.faverio@gmail.com

+393382185092

Terms of Service

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