CMR Assessment of Cardiac Microvascular Dysfunction in Patients With HFpEF (MAPPED)

Istituto Auxologico Italiano

Status: Enrolling

Conditions: Heart Failure With Reduced Ejection Fraction; Microvascular Coronary Artery Disease

Treatments: Diagnostic Test: cardiopulmonary exercise test; Diagnostic Test: stress perfusion cardiac magnetic resonance

Study type: Observational

Funder types: Other

Identifiers

NCT06316661

09C921

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

60 participants in 2 patient groups

HFpEF

Description:

patients with HFpEF

Treatment:

Diagnostic Test: stress perfusion cardiac magnetic resonance

Diagnostic Test: cardiopulmonary exercise test

healthy volunteers

Description:

healthy volunteers matched for age and sex

Treatment:

Diagnostic Test: stress perfusion cardiac magnetic resonance

Diagnostic Test: cardiopulmonary exercise test