Heart Failure With Reduced Ejection Fraction, Microvascular Coronary Artery Disease
Conditions
Brief summary
Heart failure with preserved ejection fraction (HFpEF) causes hospitalizations, premature mortality and high health care costs. This is also due to poor understanding of HFpEF pathogenesis and, thus, lack of specific therapies. Prompted by the recent demonstration that HFpEF clusters different clinical phenotypes, the investigators propose that these phenogroups are driven by distinct myocardial abnormalities. Cardiac Magnetic Resonance (CMR) can help filling this gap in knowledge: on top of providing gold standard measurements for myocardial volume and cellular mass, recent technical advantages mean that this test can assess and quantify left ventricular extracellular volume, fibrosis and microvascular function accurately and non-invasively. In HFpEF patients, the investigators aim at assessing 1) the coronary microvascular function impairment; 2) the myocardial fibrotic burden; - seeking to understand the disease in order to improve care and cardiovascular outcomes for these patients.
Interventions
DIAGNOSTIC_TESTstress perfusion cardiac magnetic resonance
stress perfusion cardiac magnetic resonance according to guidelines, with quantitative evaluation for microvascular dysfunction assessment
DIAGNOSTIC_TESTcardiopulmonary exercise test
bike exercise with ECG and non invasive respiratory gas exchange monitoring
Sponsors
Istituto Auxologico Italiano
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age greater of or equal to 18 years at enrolment * Able to provide written informed consent * Diagnosis of HFpEF as defined by the 2016 ESC Guidelines (only for HFpEF group)
Exclusion criteria
* Pregnancy or breastfeeding * Absolute contraindication to adenosine perfusion cardiac MRI (including uncontrolled asthma and severe chronic kidney failure, defined as glomerular filtration rate \< 30ml(min/kg) * Atrial fibrillation * Previous chemotherapy and/or mediastinal radiotherapy * Known CAD * Diabetes Mellitus * Systemic inflammatory diseases * Any other medical condition which, in the Investigators' opinion, could affect the study results * Only for control group: any known cardiac, pulmonary, haematological or neoplastic known medical condition and/or any chronic therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak stress perfusion | at recruitment (cross sectional) | Detection of impaired cardiac microvascular function (defined as a T1 mapping reactivity - delta T1m before and during stress test= 3.0 +/-0.9%) in HFpEF patients compared to healthy controls. |
| Extracellular volume | at recruitment (cross sectional) | Detection of higher cardiac diffuse fibrosis (defined as increased extracellular volume, measured by T1 mapping as per international guidelines, expressed as % ) in HFpEF patients compared to healthy controls. |
Countries
Italy
Contacts
Primary ContactCamilla Torlasco
Backup ContactLuca Grappiolo
Outcome results
None listed