Assessing heart function in patients with heart failure and preserved ejection fraction
MAgnetic Resonance Non-contrast Assessment of Cardiac Microvascular Dysfunction in Patients With Heart Failure With PrEserveD Ejection Fraction (MAPPED)
This study is testing how well the tiny blood vessels in the heart work in people with heart failure and preserved ejection fraction to help improve their care and outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Auxologico Italiano Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Milan) |
| Trial ID | NCT06316661 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate cardiac microvascular dysfunction in patients diagnosed with heart failure with preserved ejection fraction (HFpEF). Utilizing advanced cardiac magnetic resonance (CMR) imaging, the study will evaluate coronary microvascular function and myocardial fibrosis to better understand the underlying abnormalities associated with HFpEF. By identifying distinct clinical phenotypes and their corresponding myocardial characteristics, the research seeks to enhance patient care and cardiovascular outcomes. Participants will undergo stress perfusion cardiac MRI and cardiopulmonary exercise tests as part of the assessment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of heart failure with preserved ejection fraction.
Not a fit: Patients with conditions such as diabetes mellitus, known coronary artery disease, or severe chronic kidney failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of heart failure with preserved ejection fraction, potentially reducing hospitalizations and healthcare costs.
How similar studies have performed: While the approach of using CMR to assess microvascular function in HFpEF is gaining traction, this specific study's focus on distinct phenotypes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Milan
- IRCCS Istituto Auxologico Italiano — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Camilla Torlasco
- Email: c.torlasco@auxologico.it
- Phone: +390261911
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.