Heart FailureNCT06623344
Brain Volume and Cardiac Function in Heart Failure
A study testing Magnetic Resonance Imaging with or without Contrast in people with Heart Failure, run by Johns Hopkins University at 2 sites in United States.
Trial summary
Patients with heart failure (HF) exhibit greater structural brain alterations and higher dementia risks than the general population. Neural atrophy in nearly every region of medical limbic circuit has been observed in HF patients. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Magnetic Resonance Imaging with or without Contrast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Nov 2024to 6 Jul 2026
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with an ejection fraction (EF) below 50% who are willing to
- provide informed consent.
- Not claustrophobia.
- Age: 21 years and above.
- Ambulatory patients are eligible.
Who cannot join
- Known allergy to gadolinium contrast agents
- Metal fragments in eyes, brain, or spinal cord
- Glomerular filtration rate (GFR) 45 mL/min (using the Cockcroft-Gault formula)
- Pregnancy
- Internal electrical devices, such as cochlear implant, spinal cord stimulator, pacemaker, or defibrillator
- Presence of any other history or condition that the investigator feels would be problematic
- Severe claustrophobia
- Weight exceeding 300 lbs. (MRI table weight restrictions)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Center for Advanced Imaging and Research Science, Johns Hopkins Science + Technology Park at 1812 Ashland Avenue, Baltimore, MD
Baltimore, Maryland, 21287
Johns Hopkins Hospital
Baltimore, Maryland, 21287
About this study
Patients with heart failure (HF) exhibit greater structural brain alterations and higher dementia risks than the general population. Neural atrophy in nearly every region of medical limbic circuit has been observed in HF patients. Reduction of cerebral blood flow has been suggested as the pathophysiological pathway linking HF and structural brain changes. Indeed, lower cardiac index levels were related to lower cerebral blood flow in older adults without stroke, dementia, or heart failure. A few prior studies have examined the subcortical structural differences in patients with HF compared to controls. Brain volume loss (including putamen and hippocampal volumes) have been reported in patients with low ejection fraction. Significant gray matter loss was found in specific brain regions of HF patients and included structures that serve demonstrated roles in cognitive functions. In the investigator's previous study (Comprehensive Imaging Exam of Convalesced COVID-19 Patients - COVID-19 RELATED SUBMISSION-IRB00252436), involving 100 participants (volunteers with normal heart function (ejection fraction; 50%)), the investigators observed significant correlations between thalamic volumes and ventricular stroke volumes in volunteers. Building on these findings, the investigators intend to expand the research to include individuals with heart failure (HF), employing the same MRI protocol. The study will involve obtaining a set of T1-weighted brain images to measure the volumes of seven subcortical structures. The investigators goal is to explore the relationship between subcortical volumes and cardiac parameters. Additionally, the investigators will examine whether patients with HF experience a more rapid reduction in subcortical volumes compared to those with normal cardiac function (EF;50%).
Read the detailed description
Heart failure (HF) is a multifaceted clinical syndrome characterized by the heart's inability to effectively pump blood to meet the body's demands. This condition often results from various structural or functional cardiac disorders, impacting not only the heart but also multiple organ systems, including the brain, kidneys, lungs, and circulatory system. Patients with heart failure present a spectrum of symptoms that significantly affect quality of life, such as dyspnea and fatigue, and are typically identified by cardiac dysfunction markers like abnormal left or right ventricular filling and elevated filling pressures. Recent advances in diagnostic technologies, particularly in imaging modalities like Cardiovascular Magnetic Resonance Imaging (CMR), have opened new avenues for in-depth exploration of heart failure's underlying pathophysiology. CMR is increasingly used in heart failure management for risk stratification, viability assessment, and diagnosing conditions like myocarditis and cardiomyopathy. This technology enables detailed assessment of myocardial function, structural changes, and interactions with other organ systems. Patients with heart failure exhibit greater structural brain alterations and higher dementia risks than the general population. Neural atrophy in nearly every region of medical limbic circuit has been observed in HF patients. Initial research showed a strong correlation between thalamic volumes and ventricular stroke volumes in healthy volunteers. The investigators plan to extend this study to heart failure (HF) patients using the same MRI methods to assess the connection between subcortical brain volumes and heart health. Additionally, the investigators will explore if HF patients experience a faster decline in these brain volumes than individuals with normal heart function.
- Objectives:
Primary: To access the correlation of cardiac structure and function to the subcortical volumes in patients with heart failure.
Secondary: To compare the correlation between cardiac structure and function and subcortical volumes in heart failure patients with that in participants with normal heart function.
- Conditions
- Heart Failure
- Being tested
- Magnetic Resonance Imaging with or without Contrast
- Keywords
- Heart Failure, Cardiovascular Magnetic Resonance Imaging, brain
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging with or without ContrastOther
Completion of Magnetic Resonance Imaging of the brain, heart, lungs, and liver with and without contrast.
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized | Other | Participants who were hospitalized due to heart failure (HF) illness. Receives: Other: Magnetic Resonance Imaging with or without Contrast |
| Non-Hospitalized | Other | Participants who had heart failure (HF) but did not require hospitalization secondary to the illness. Receives: Other: Magnetic Resonance Imaging with or without Contrast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subcortical Volumes in Heart Failure
To access the correlation of cardiac structure and function to the subcortical volumes in patients with heart failure.
Measured: From enrollment up to 30 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start10 Nov 2024
- Primary completion6 Jul 2026
- Study completion6 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Canon Medical Systems, USA
- Responsible party
- Sponsor
- Investigators
- Joao AC Lima, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623344
- Sponsor's protocol ID
- IRB00418683
- Status last verified
- Jul 2026
- First submitted
- 30 Sep 2024
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may provided to qualified researchers with academic interest in COVID-19. Data shared will not contain any personal health information (PHI). A statement of work and data use agreement are pre-requisites for data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Volume and Cardiac Function in Heart Failure
- ClinicalTrials.gov ID
- NCT06623344
- Acronym / sponsor ID
- IRB00418683
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Cardiovascular Magnetic Resonance Imaging, brain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Canon Medical Systems, USA
- Study start
- 10 Nov 2024 (actual)
- Primary completion
- 6 Jul 2026 (actual)
- Study completion
- 6 Jul 2026 (actual)
- First posted
- 2 Oct 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.
Patients with heart failure (HF) exhibit greater structural brain alterations and higher dementia risks than the general population. Neural atrophy in nearly every region of medical limbic circuit has been observed in HF patients. Reduction of cerebral blood flow has been suggested as the pathophysiological pathway linking HF and structural brain changes. Indeed, lower cardiac index levels were related to lower cerebral blood flow in older adults without stroke, dementia, or heart failure. A few prior studies have examined the subcortical structural differences in patients with HF compared to controls. Brain volume loss (including putamen and hippocampal volumes) have been reported in patients with low ejection fraction. Significant gray matter loss was found in specific brain regions of HF patients and included structures that serve demonstrated roles in cognitive functions. In the investigator's previous study (Comprehensive Imaging Exam of Convalesced COVID-19 Patients - COVID-19 RELATED SUBMISSION-IRB00252436), involving 100 participants (volunteers with normal heart function (ejection fraction; 50%)), the investigators observed significant correlations between thalamic volumes and ventricular stroke volumes in volunteers. Building on these findings, the investigators intend to expand the research to include individuals with heart failure (HF), employing the same MRI protocol. The study will involve obtaining a set of T1-weighted brain images to measure the volumes of seven subcortical structures. The investigators goal is to explore the relationship between subcortical volumes and cardiac parameters. Additionally, the investigators will examine whether patients with HF experience a more rapid reduction in subcortical volumes compared to those with normal cardiac function (EF;50%).
Detailed description
Heart failure (HF) is a multifaceted clinical syndrome characterized by the heart's inability to effectively pump blood to meet the body's demands. This condition often results from various structural or functional cardiac disorders, impacting not only the heart but also multiple organ systems, including the brain, kidneys, lungs, and circulatory system. Patients with heart failure present a spectrum of symptoms that significantly affect quality of life, such as dyspnea and fatigue, and are typically identified by cardiac dysfunction markers like abnormal left or right ventricular filling and elevated filling pressures. Recent advances in diagnostic technologies, particularly in imaging modalities like Cardiovascular Magnetic Resonance Imaging (CMR), have opened new avenues for in-depth exploration of heart failure's underlying pathophysiology. CMR is increasingly used in heart failure management for risk stratification, viability assessment, and diagnosing conditions like myocarditis and cardiomyopathy. This technology enables detailed assessment of myocardial function, structural changes, and interactions with other organ systems. Patients with heart failure exhibit greater structural brain alterations and higher dementia risks than the general population. Neural atrophy in nearly every region of medical limbic circuit has been observed in HF patients. Initial research showed a strong correlation between thalamic volumes and ventricular stroke volumes in healthy volunteers. The investigators plan to extend this study to heart failure (HF) patients using the same MRI methods to assess the connection between subcortical brain volumes and heart health. Additionally, the investigators will explore if HF patients experience a faster decline in these brain volumes than individuals with normal heart function.
- Objectives:
Primary: To access the correlation of cardiac structure and function to the subcortical volumes in patients with heart failure.
Secondary: To compare the correlation between cardiac structure and function and subcortical volumes in heart failure patients with that in participants with normal heart function.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospitalized | Other | Other: Magnetic Resonance Imaging with or without ContrastParticipants who were hospitalized due to heart failure (HF) illness. |
| Non-Hospitalized | Other | Other: Magnetic Resonance Imaging with or without ContrastParticipants who had heart failure (HF) but did not require hospitalization secondary to the illness. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals with an ejection fraction (EF) below 50% who are willing to
- provide informed consent.
- Not claustrophobia.
- Age: 21 years and above.
- Ambulatory patients are eligible.
Key exclusion criteria (8 listed)
- Known allergy to gadolinium contrast agents
- Metal fragments in eyes, brain, or spinal cord
- Glomerular filtration rate (GFR) 45 mL/min (using the Cockcroft-Gault formula)
- Pregnancy
- Internal electrical devices, such as cochlear implant, spinal cord stimulator, pacemaker, or defibrillator
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 |
|---|---|---|
| Magnetic Resonance Imaging with or without ContrastCompletion of Magnetic Resonance Imaging of the brain, heart, lungs, and liver with and without contrast. | Other | Hospitalized, Non-Hospitalized |
Primary outcome
Subcortical Volumes in Heart Failure
Time frame: From enrollment up to 30 days post treatment
To access the correlation of cardiac structure and function to the subcortical volumes in patients with heart failure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: Yes. Data obtained through this study may provided to qualified researchers with academic interest in COVID-19. Data shared will not contain any personal health information (PHI). A statement of work and data use agreement are pre-requisites for data sharing.
Related trials for Heart Failure
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Recruiting
Leg Heat Therapy in Heart Failure With Preserved Ejection Fraction
Heart Failure With Preserved Ejection Fraction
Recruiting
Vsling™ III: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure
HFrEF - Heart Failure With Reduced Ejection Fraction
RecruitingPhase 3
A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure
Heart Failure
Active, not recruiting
Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
Heart Failure With Preserved Ejection Fraction, Concentric Hypertrophy
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.
Joao AC Lima, MD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging with or without Contrast in people with Heart Failure, run by Johns Hopkins University at 2 sites in United States.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subcortical Volumes in Heart Failure (time frame: From enrollment up to 30 days post treatment). 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 17 Jul 2026.