CMR Assessment of Cardiac Microvascular Dysfunction in Patients With HFpEF

NCT ID: NCT06316661

Last Updated: 2024-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-01

Study Completion Date

2024-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Microvascular Coronary Artery Disease Heart Failure With Reduced Ejection Fraction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HFpEF

patients with HFpEF

stress perfusion cardiac magnetic resonance

Intervention Type DIAGNOSTIC_TEST

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

cardiopulmonary exercise test

Intervention Type DIAGNOSTIC_TEST

bike exercise with ECG and non invasive respiratory gas exchange monitoring

healthy volunteers

healthy volunteers matched for age and sex

stress perfusion cardiac magnetic resonance

Intervention Type DIAGNOSTIC_TEST

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

cardiopulmonary exercise test

Intervention Type DIAGNOSTIC_TEST

bike exercise with ECG and non invasive respiratory gas exchange monitoring

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

stress perfusion cardiac magnetic resonance

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

Intervention Type DIAGNOSTIC_TEST

cardiopulmonary exercise test

bike exercise with ECG and non invasive respiratory gas exchange monitoring

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istituto Auxologico Italiano

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

IRCCS Istituto Auxologico Italiano

Milan, , Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Camilla Torlasco

Role: CONTACT

+390261911 ext. 2932

Luca Grappiolo

Role: CONTACT

+390261911 ext. 2894

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Camilla Torlasco

Role: primary

+390261911 ext. 2932

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

09C921

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Diffusion MRI in Heart Failure
NCT02973633 RECRUITING EARLY_PHASE1
Study of Blood Flow in Heart Muscle
NCT00001631 COMPLETED PHASE2