Idiopathic Pulmonary FibrosisCardioIPFNCT04177251
Cardiovascular Fibrosis in Idiopathic Pulmonary Fibrosis
An observational study of Idiopathic Pulmonary Fibrosis and Cardiac Fibrosis, run by San Gerardo Hospital at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Cardiac Fibrosis, Arterial Fibrosis
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 21 Oct 2019to 15 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Consecutive patients with diagnosis of IPF
Who may be able to join
- diagnosis of idiopathic pulmonary fibrosis according to the 2011 ATS / ERS guidelines with Multidisciplinary discussion;
- informed consent signed and obtained before study enrollment.
- informed consent signed and obtained before study enrollment.
Who cannot join
- 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).
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- For healthy volunteers:
- 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 locations and contacts
1 site in 1 country.
Italy1 site
Ospedale San Gerardo Monza - Università Milano Bicocca
Monza, MB, 20900
About this study
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.
Read the detailed 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.
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
levels of biomarkers analysed will be evaluated through ELISA tests
Measured: visit 1 (T1) - duration 1 day
IPF progression after 1 year from diagnosis in IPF patients
IPF progression is defined as at least one of the following a) absolute decrease of 10% of predicted compared to the baseline in the forced vital capacity (FVC), or b) absolute decrease of 15% of predicted compared to the baseline in the DLco, or c) acute exacerbation of IPF, or d) IPF-related death, or e) lung transplantation, or f) hospitalisation for respiratory causes.
Measured: up yo 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start21 Oct 2019
- Primary completion15 Oct 2022
- Study completion15 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Gerardo Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paola Faverio, San Gerardo Hospital
- Investigators
- Paola Faverio, MD, Principal investigator, Università degli Studi di Milano Bicocca - Ospedale San Gerardo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177251
- Sponsor's protocol ID
- 1349/2019
- Acronym
- CardioIPF
- Status last verified
- Oct 2022
- First submitted
- 19 Nov 2019
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Fibrosis in Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT04177251
- Acronym / sponsor ID
- CardioIPF / 1349/2019
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- San Gerardo HospitalUniversity, hospital or other
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 26 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with diagnosis of IPF
Key inclusion criteria (3 listed)
- diagnosis of idiopathic pulmonary fibrosis according to the 2011 ATS / ERS guidelines with Multidisciplinary discussion;
- informed consent signed and obtained before study enrollment.
- informed consent signed and obtained before study enrollment.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
presence of cardiac fibrosis in a population of patients with overt IPF at diagnosis in comparison with healthy controls
Time frame: During visit 2 (T2) (to be performed within 1 month from visit 1) - duration 1day
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.
presence of vascular fibrosis in a population of patients with overt IPF at diagnosis in comparison with healthy controls
Time frame: During visit 2 (T2) (to be performed within 1 month from visit 1) - duration 1 day
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.
2 secondary outcomes
levels of biomarkers analysed (galectins-3, osteopontin and periostin)
Time frame: visit 1 (T1) - duration 1 day
IPF progression after 1 year from diagnosis in IPF patients
Time frame: up yo 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paola Faverio, MD principal investigator
Università degli Studi di Milano Bicocca - Ospedale San Gerardo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis and Cardiac Fibrosis, run by San Gerardo Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of cardiac fibrosis in a population of patients with overt IPF at diagnosis in comparison with healthy controls (time frame: During visit 2 (T2) (to be performed within 1 month from visit 1) - duration 1day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.