CMR Assessment of Cardiac Microvascular Dysfunction in Patients With HFpEF

NCT06316661 | Recruiting

• 1 other identifier: 09C921
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Microvascular Coronary Artery Disease; Heart Failure With Reduced Ejection Fraction

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (2)

HFpEF

patients with HFpEF

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

healthy volunteers

healthy volunteers matched for age and sex

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

Interventions

stress perfusion cardiac magnetic resonance DIAGNOSTIC_TEST

stress perfusion cardiac magnetic resonance according to guidelines, with quantitative evaluation for microvascular dysfunction assessment

HFpEF; healthy volunteers

cardiopulmonary exercise test DIAGNOSTIC_TEST

bike exercise with ECG and non invasive respiratory gas exchange monitoring

HFpEF; healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

IRCCS Istituto Auxologico Italiano

Milan, 20149, Italy

RECRUITING

MeSH Terms

Interventions

Exercise Test

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Central Study Contacts

Camilla Torlasco

CONTACT

+390261911; c.torlasco@auxologico.it

Luca Grappiolo

CONTACT

+390261911; luca.grappiolo@auxologico.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 18, 2024
• Study Start: March 1, 2019
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)