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

MAgnetic Resonance Non-contrast Assessment of Cardiac Microvascular Dysfunction in Patients With Heart Failure With PrEserveD Ejection Fraction (MAPPED)

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure With Reduced Ejection Fraction; Microvascular Coronary Artery Disease
• Intervention / Treatment: Diagnostic test: stress perfusion cardiac magnetic resonance; Diagnostic test: cardiopulmonary exercise test

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Luca Grappiolo; Phone Number: 2894 +390261911; Email: luca.grappiolo@auxologico.it
• Study Contact Backup: Name: Camilla Torlasco; Phone Number: 2932 +390261911; Email: c.torlasco@auxologico.it

Study Locations

• Italy
  • Milan, Italy, 20149
    • Recruiting
    • IRCCS Istituto Auxologico Italiano
    • Contact: Camilla Torlasco; Phone Number: 2932 +390261911; Email: c.torlasco@auxologico.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

N=40 patients will be recruited in the HFpEF group (from now on "HFpEF"), N=20 in the control group (from now on "Controls").

• HFpEF: Eligible HFpEF patients will be identified in the Auxologico Outpatient Clinics (in particular in the Dyspnoea and Pulmonary Hypertension Clinic, run by Dr Sergio Caravita), with the aim to include 20 patients with early stages of disease (high filling pressure only during exercise, with nonconclusive results of rest examinations, roughly corresponding to Shah's phenogroup n 1) and 20 patients with advanced stages of disease (signs of pulmonary hypertension and right ventricular dysfunction, roughly corresponding to Shah's phenogroup n 3).
• Controls: healthy volunteers will be matched for age and gender to the HFpEF.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HFpEF; patients with HFpEF	Diagnostic test: stress perfusion cardiac magnetic resonance; stress perfusion cardiac magnetic resonance according to guidelines, with quantitative evaluation for microvascular dysfunction assessment; Diagnostic test: cardiopulmonary exercise test; bike exercise with ECG and non invasive respiratory gas exchange monitoring
healthy volunteers; healthy volunteers matched for age and sex	Diagnostic test: stress perfusion cardiac magnetic resonance; stress perfusion cardiac magnetic resonance according to guidelines, with quantitative evaluation for microvascular dysfunction assessment; Diagnostic test: cardiopulmonary exercise test; bike exercise with ECG and non invasive respiratory gas exchange monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak stress perfusion	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.	at recruitment (cross sectional)
Extracellular volume	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.	at recruitment (cross sectional)

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Failure; Coronary Artery Disease
• Other Study ID Numbers: 09C921

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No