CMR Assessment of Cardiac Microvascular Dysfunction in Patients With HFpEF

Heart Failure With Reduced Ejection Fraction Clinical Trial

— MAPPED  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06316661
• Other study ID #: 09C921
• Status: Recruiting
• Start date: March 1, 2019
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2024
• Source: Istituto Auxologico Italiano
• Contact: Camilla Torlasco
• Phone: +390261911
• Email: c.torlasco[@]auxologico.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Failure
• Heart Failure With Reduced Ejection Fraction
• Microvascular Coronary Artery Disease

Intervention

Diagnostic Test:
• stress perfusion cardiac magnetic resonance
stress perfusion cardiac magnetic resonance according to guidelines, with quantitative evaluation for microvascular dysfunction assessment
• cardiopulmonary exercise test
bike exercise with ECG and non invasive respiratory gas exchange monitoring

Locations

Country	Name	City	State
Italy	IRCCS Istituto Auxologico Italiano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)