Cardiovascular Fibrosis in Idiopathic Pulmonary Fibrosis

NCT04177251 | Completed

• 1 other identifier: 1349/2019
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Idiopathic Pulmonary Fibrosis; Cardiac Fibrosis; Arterial Fibrosis

Outcome Measures

Primary Outcomes (2)

• presence of cardiac fibrosis in a population of patients with overt IPF at diagnosis in comparison with healthy controls

  Cardiac fibrosis will be evaluated with echocardiography and defined according to the latest guidelines on heart failure as the presence of signs and symptoms of cardiac instability (dyspnea on exertion, asthenia, pulmonary or peripheral congestion) with the finding of a conserved EF (\> 50%), the presence of high NT-proBNP (\> 125 pg / mL) and one of the following two criteria: 1 - presence of left ventricular hypertrophy (septal thickness) \> = 11 mm or indexed left ventricular mass\> 125 g / m2 in men or\> 95 g / m2 in women) or left atrial dilation (area\> 20 cm2 or atrial volume\> 55 mL); 2 - presence of diastolic dysfunction from 2nd to 4th grade (assessed by the E / A, dec time and E / E 'ratio echocardiography). Given the new definition in the guidelines of heart failure for intermediate EF (equal criteria but with EF between 40 and 49%) this diagnosis will also be taken into account.

  During visit 2 (T2) (to be performed within 1 month from visit 1) - duration 1day

• presence of vascular fibrosis in a population of patients with overt IPF at diagnosis in comparison with healthy controls

  Vascular fibrosis is measured with FMD and PWV, a value less than 4% and greater than 10 cm / s, respectively, will be indicative of a reduction in endothelial function and an increase in vascular stiffness. It is sufficient for one of the two parameters to exceed the threshold value in order to diagnose vascular fibrosis.

  During visit 2 (T2) (to be performed within 1 month from visit 1) - duration 1 day

Secondary Outcomes (2)

• levels of biomarkers analysed (galectins-3, osteopontin and periostin)

  visit 1 (T1) - duration 1 day

• IPF progression after 1 year from diagnosis in IPF patients

  up yo 1 year

Other Outcomes (1)

• blood proteomic and metabolomic biomarkers

  during visit 1 (T1) - duration 1 day

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with diagnosis of IPF

You may qualify if:

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

You may not qualify if:

• 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:
• \- informed consent signed and obtained before study enrollment.
• 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.

Sponsors & Collaborators

• San Gerardo Hospital: lead

Study Sites (1)

Ospedale San Gerardo Monza - Università Milano Bicocca

Monza, MB, 20900, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples collected at T1 for: 1. ELISA assay for periostin, galectin n-3, osteopontin and pro-BNP determination 2. metabolomic and proteomic analyses

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Paola Faverio, MD

  Università degli Studi di Milano Bicocca - Ospedale San Gerardo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 26, 2019
• Study Start: October 21, 2019
• Primary Completion: October 15, 2022
• Study Completion: October 15, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-10

Locations

IT (1)