CMR Assessment of Cardiac Microvascular Dysfunction in Patients With HFpEF

Recruiting

• Conditions: Microvascular Coronary Artery Disease; Heart Failure With Reduced Ejection Fraction
• Interventions: Diagnostic Test: stress perfusion cardiac magnetic resonance; Diagnostic Test: cardiopulmonary exercise test

• Registration Number: NCT06316661
• Lead Sponsor: Istituto Auxologico Italiano

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-03-14
• Last Update Submitted: 2024-03-14
• Study First Posted: 2024-03-18
• Last Update Posted: 2024-03-18
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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)

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
healthy volunteers	stress perfusion cardiac magnetic resonance	healthy volunteers matched for age and sex
healthy volunteers	cardiopulmonary exercise test	healthy volunteers matched for age and sex
HFpEF	stress perfusion cardiac magnetic resonance	patients with HFpEF
HFpEF	cardiopulmonary exercise test	patients with HFpEF

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

IRCCS Istituto Auxologico Italiano; 🇮🇹 Milan, Italy