Microvascular Coronary Artery DiseaseMAPPEDNCT06316661
CMR Assessment of Cardiac Microvascular Dysfunction in Patients With HFpEF
An observational study of Microvascular Coronary Artery Disease and Heart Failure With Reduced Ejection Fraction, run by Istituto Auxologico Italiano at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Microvascular Coronary Artery Disease, Heart Failure With Reduced Ejection Fraction
- What is being tested?
- stress perfusion cardiac magnetic resonance and cardiopulmonary exercise test
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2019to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Auxologico Italiano
Milan, 20149
Camilla Torlasco, +390261911 ext. 2932, c.torlasco@auxologico.it
About this study
Official title: 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.
- Being tested
- stress perfusion cardiac magnetic resonance, cardiopulmonary exercise test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stress perfusion cardiac magnetic resonanceDiagnostic test
stress perfusion cardiac magnetic resonance according to guidelines, with quantitative evaluation for microvascular dysfunction assessment
cardiopulmonary exercise testDiagnostic test
bike exercise with ECG and non invasive respiratory gas exchange monitoring
| Study group | Role | What they receive |
|---|---|---|
| HFpEF | patients with HFpEF Receives: Diagnostic Test: stress perfusion cardiac magnetic resonance; Diagnostic Test: cardiopulmonary exercise test | |
| healthy volunteers | healthy volunteers matched for age and sex Receives: Diagnostic Test: stress perfusion cardiac magnetic resonance; Diagnostic Test: cardiopulmonary exercise test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: at recruitment (cross sectional)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start1 Mar 2019
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microvascular Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316661
- Sponsor's protocol ID
- 09C921
- Acronym
- MAPPED
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MAgnetic Resonance Non-contrast Assessment of Cardiac Microvascular Dysfunction in Patients With Heart Failure With PrEserveD Ejection Fraction (MAPPED)
- ClinicalTrials.gov ID
- NCT06316661
- Acronym / sponsor ID
- MAPPED / 09C921
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFpEF | – | Diagnostic Test: stress perfusion cardiac magnetic resonance, Diagnostic Test: cardiopulmonary exercise testpatients with HFpEF |
| healthy volunteers | – | Diagnostic Test: stress perfusion cardiac magnetic resonance, Diagnostic Test: cardiopulmonary exercise testhealthy volunteers matched for age and sex |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stress perfusion cardiac magnetic resonancestress perfusion cardiac magnetic resonance according to guidelines, with quantitative evaluation for microvascular dysfunction assessment | Diagnostic test | HFpEF, healthy volunteers |
| cardiopulmonary exercise testbike exercise with ECG and non invasive respiratory gas exchange monitoring | Diagnostic test | HFpEF, healthy volunteers |
Primary outcome
Peak stress perfusion
Time frame: at recruitment (cross sectional)
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.
Extracellular volume
Time frame: at recruitment (cross sectional)
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microvascular Coronary Artery Disease and Heart Failure With Reduced Ejection Fraction, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Camilla Torlasco (+390261911 ext. 2932, c.torlasco@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak stress perfusion (time frame: at recruitment (cross sectional)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.