Brain Volume and Cardiac Function in Heart Failure

NCT06623344 | Recruiting

• 1 other identifier: IRB00418683
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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. 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%).

Conditions

Heart Failure

Keywords

Heart Failure; Cardiovascular Magnetic Resonance Imaging; brain

Outcome Measures

Primary Outcomes (1)

• Subcortical Volumes in Heart Failure

  To access the correlation of cardiac structure and function to the subcortical volumes in patients with heart failure.

  From enrollment up to 30 days post treatment

Study Arms (2)

Hospitalized

OTHER

Participants who were hospitalized due to heart failure (HF) illness.

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.

Other: Magnetic Resonance Imaging with or without Contrast

Interventions

Magnetic Resonance Imaging with or without Contrast OTHER

Completion of Magnetic Resonance Imaging of the brain, heart, lungs, and liver with and without contrast.

Hospitalized; Non-Hospitalized

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johns Hopkins University: lead
• Canon Medical Systems, USA: collaborator

Study Sites (2)

Johns Hopkins Center for Advanced Imaging and Research Science, Johns Hopkins Science + Technology Park at 1812 Ashland Avenue, Baltimore, MD

Baltimore, Maryland, 21287, United States

RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Magnetic Resonance Spectroscopy; Contrast Media

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Joao AC Lima, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joao Lima, MD

CONTACT

410-614-1284; jlima@jhmi.edu

Jason Ortman

CONTACT

jortman1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 2, 2024
• Study Start: November 10, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Data requests can be submitted starting 12 months after article publication. Data will be made accessible up to 24 months with extensions considered as needed.
• Access Criteria: Access provided upon request.

Locations

US (2)