Heart Failure (HF)NCT07485816
A Study on the Correlation Between Cardiac-Cerebral Oxygenation Reserve and Cognitive Function Changes in Heart Failure Patients
An observational study of Heart Failure (HF), run by Yan'an Affiliated Hospital of Kunming Medical University at 1 site in China.
Trial summary
At different stages of heart failure (HF), the cardiac and cerebral oxygen reserve exhibits varying degrees of decline due to chronic hypoxia and microvascular dysfunction caused by reduced cardiac output, leading to cognitive dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure (HF)
- What is being tested?
- breathing training
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2026to 15 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: NYHA classification II=IV heart failure patients and age- and sex-matched control group
Who may be able to join
- Aged >18 years and <70 years. (2)Hospitalized for HF or clinically diagnosed with HF and admitted as an inpatient
Who cannot join
- (1)Concurrent severe non-cardiac oxygen metabolism diseases (e.g., severe Chronic Obstructive Pulmonary Disease (COPD) or end-stage renal failure). (2)Myocardial infarction or stroke within the last 90 days. (3)Contraindications to MRI. (4)Inability to cooperate with the examinations
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Yan'an Hospital Affiliated to Kunming Medical University
Kunming, Yunnan, 650051
About this study
Official title: Assessing the Cardio-Cerebral Oxygenation Reserve in Heart Failure Patients Using Oxygen-Sensitive Magnetic Resonance Imaging Technology
At different stages of heart failure (HF), the cardiac and cerebral oxygen reserve exhibits varying degrees of decline due to chronic hypoxia and microvascular dysfunction caused by reduced cardiac output, leading to cognitive dysfunction. As a direct marker of microvascular function, early identification and intervention of cardiac and cerebral oxygen reserve are crucial to prevent irreversible damage to organs such as the heart and brain. However, there is currently no precise and effective method to quantify cardiac and cerebral oxygen reserve. Oxygen-sensitive magnetic resonance imaging (OS-MRI), as an emerging functional imaging technique, can dynamically monitor oxygenation changes and oxygen reserve capacity in Homo sapiens tissues. However, due to its technical complexity, its application in combined cardiac and cerebral assessment in HF patients remains underexplored.
This prospective, single-center cohort study employs OS-MRI combined with respiratory maneuvers to examine the heart and brain in HF patients at different stages. Continuous image acquisition is performed during hyperventilation to breath-holding, and myocardial oxygen reserve (MORE) and cerebral oxygen reserve (CORE) are derived using MATLAB and CVI42 post-processing software. Cognitive function is assessed using the Montreal Cognitive Assessment (MoCA) scale, with scores <26 indicating mild cognitive dysfunction. Subsequently, SPSS is used to analyze the correlation between cardiac/cerebral oxygen reserve and MoCA scores, providing imaging-based evidence for early clinical detection of oxygen reserve decline in HF patients and confirming the potential link between cardiac/cerebral oxygen reserve, HF, and cognitive dysfunction.
Read the detailed description
Heart failure (Heart Failure, HF) is a complex clinical syndrome often caused by structural abnormalities in the heart (Broussonetia papyrifera) and functional impairments (Parazacco spilurus subsp. spilurus). Its high incidence and rehospitalization rates have become a major global public health burden. In addition to typical symptoms such as dyspnea, fatigue, and fluid retention, growing evidence indicates that HF patients commonly exhibit varying degrees of cognitive dysfunction, spanning domains such as executive function, memory, and information processing speed. This not only severely impacts patients' quality of life and treatment adherence but also serves as an independent predictor of poor prognosis, highlighting the urgency of clinical management for "cardio-cerebral comorbidity." Cardio-cerebral oxygen reserve, which evaluates the intrinsic potential of the heart and brain-two core organs-to maintain oxygen supply and functional stability under physiological stress, serves as a key physiological bridge linking cardiac insufficiency and cerebral injury. Currently, multiple hypotheses attempt to explain the pathological mechanisms by which HF leads to cognitive decline, including chronic cerebral hypoperfusion, persistent overactivation of the neurohumoral system, systemic endothelial dysfunction, and the resulting oxidative stress and microvascular damage. However, how these mechanisms specifically affect the oxygen metabolism balance between the heart and brain in HF patients, as well as the precise role of cardio-cerebral oxygen reserve in this process, remains unclear. This limits our systemic understanding of heart-brain interactions from a holistic perspective and hinders the development of related therapeutic strategies.
On the technical front, oxygen-sensitive magnetic resonance imaging (OS-MRI) has emerged as a non-invasive imaging modality capable of directly and quantitatively assessing oxygenated status in tissue microcirculation through the blood oxygen level-dependent (BOLD) effect, offering a unique perspective for evaluating organ oxygen reserve. Although this technique has demonstrated potential in studies of macrovascular and coronary artery diseases, as well as myocardial microvascular dysfunction in HF with preserved ejection fraction (HFpEF), its application in synchronously and integratively assessing cardiac and cerebral oxygen responses in the same HF individual and directly correlating them with neuropsychological performance remains unexplored .
Therefore, this study aims to quantitatively analyze cardio-cerebral oxygen reserve in HF patients using OS-MRI and systematically evaluate their cognitive function with the Montreal Cognitive Assessment (MoCA). By examining the correlation between changes in cardio-cerebral oxygen reserve and cognitive function, we seek to determine whether cardio-cerebral oxygen reserve can serve as an early and effective imaging biomarker for predicting the risk of cognitive decline in HF patients, thereby providing direct imaging evidence to elucidate the "heart-brain axis" mechanism underlying HF-related cognitive disorders.
- Conditions
- Heart Failure (HF)
- Being tested
- breathing training
- Keywords
- Heart Failure, cardio-cerebral oxygenation reserve, cognitive dysfunction, OS-MRI
- Medical subject headings
- Heart Failure, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breathing trainingBehavioural
Before MRI scanning, participant will trained to exhale and hold their breath
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure Patients group | enrolled NYHA II-IV level heart failure patients Receives: Behavioral: breathing training | |
| Healthy Control group | confirmed to have no ischemic heart disease by physical examination and echocardiography, will be recruited. Receives: Behavioral: breathing training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function decline
The MoCA scoreless than 26 points is considered to indicate cognitive dysfunction
Measured: Within after MRI scanning 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start15 Mar 2026 (estimated)
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure (HF)Studies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yan'an Affiliated Hospital of Kunming Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YANGLEI, Yan'an Affiliated Hospital of Kunming Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485816
- Sponsor's protocol ID
- 2025-342-01
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Cardio-Cerebral Oxygenation Reserve in Heart Failure Patients Using Oxygen-Sensitive Magnetic Resonance Imaging Technology
- ClinicalTrials.gov ID
- NCT07485816
- Acronym / sponsor ID
- 2025-342-01
- Conditions
- Heart Failure (HF)
- Keywords
- Heart Failure, cardio-cerebral oxygenation reserve, cognitive dysfunction, OS-MRI
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yan'an Affiliated Hospital of Kunming Medical UniversityUniversity, hospital or other
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 20 Mar 2026 (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.
At different stages of heart failure (HF), the cardiac and cerebral oxygen reserve exhibits varying degrees of decline due to chronic hypoxia and microvascular dysfunction caused by reduced cardiac output, leading to cognitive dysfunction. As a direct marker of microvascular function, early identification and intervention of cardiac and cerebral oxygen reserve are crucial to prevent irreversible damage to organs such as the heart and brain. However, there is currently no precise and effective method to quantify cardiac and cerebral oxygen reserve. Oxygen-sensitive magnetic resonance imaging (OS-MRI), as an emerging functional imaging technique, can dynamically monitor oxygenation changes and oxygen reserve capacity in Homo sapiens tissues. However, due to its technical complexity, its application in combined cardiac and cerebral assessment in HF patients remains underexplored.
This prospective, single-center cohort study employs OS-MRI combined with respiratory maneuvers to examine the heart and brain in HF patients at different stages. Continuous image acquisition is performed during hyperventilation to breath-holding, and myocardial oxygen reserve (MORE) and cerebral oxygen reserve (CORE) are derived using MATLAB and CVI42 post-processing software. Cognitive function is assessed using the Montreal Cognitive Assessment (MoCA) scale, with scores <26 indicating mild cognitive dysfunction. Subsequently, SPSS is used to analyze the correlation between cardiac/cerebral oxygen reserve and MoCA scores, providing imaging-based evidence for early clinical detection of oxygen reserve decline in HF patients and confirming the potential link between cardiac/cerebral oxygen reserve, HF, and cognitive dysfunction.
Detailed description
Heart failure (Heart Failure, HF) is a complex clinical syndrome often caused by structural abnormalities in the heart (Broussonetia papyrifera) and functional impairments (Parazacco spilurus subsp. spilurus). Its high incidence and rehospitalization rates have become a major global public health burden. In addition to typical symptoms such as dyspnea, fatigue, and fluid retention, growing evidence indicates that HF patients commonly exhibit varying degrees of cognitive dysfunction, spanning domains such as executive function, memory, and information processing speed. This not only severely impacts patients' quality of life and treatment adherence but also serves as an independent predictor of poor prognosis, highlighting the urgency of clinical management for "cardio-cerebral comorbidity." Cardio-cerebral oxygen reserve, which evaluates the intrinsic potential of the heart and brain-two core organs-to maintain oxygen supply and functional stability under physiological stress, serves as a key physiological bridge linking cardiac insufficiency and cerebral injury. Currently, multiple hypotheses attempt to explain the pathological mechanisms by which HF leads to cognitive decline, including chronic cerebral hypoperfusion, persistent overactivation of the neurohumoral system, systemic endothelial dysfunction, and the resulting oxidative stress and microvascular damage. However, how these mechanisms specifically affect the oxygen metabolism balance between the heart and brain in HF patients, as well as the precise role of cardio-cerebral oxygen reserve in this process, remains unclear. This limits our systemic understanding of heart-brain interactions from a holistic perspective and hinders the development of related therapeutic strategies.
On the technical front, oxygen-sensitive magnetic resonance imaging (OS-MRI) has emerged as a non-invasive imaging modality capable of directly and quantitatively assessing oxygenated status in tissue microcirculation through the blood oxygen level-dependent (BOLD) effect, offering a unique perspective for evaluating organ oxygen reserve. Although this technique has demonstrated potential in studies of macrovascular and coronary artery diseases, as well as myocardial microvascular dysfunction in HF with preserved ejection fraction (HFpEF), its application in synchronously and integratively assessing cardiac and cerebral oxygen responses in the same HF individual and directly correlating them with neuropsychological performance remains unexplored .
Therefore, this study aims to quantitatively analyze cardio-cerebral oxygen reserve in HF patients using OS-MRI and systematically evaluate their cognitive function with the Montreal Cognitive Assessment (MoCA). By examining the correlation between changes in cardio-cerebral oxygen reserve and cognitive function, we seek to determine whether cardio-cerebral oxygen reserve can serve as an early and effective imaging biomarker for predicting the risk of cognitive decline in HF patients, thereby providing direct imaging evidence to elucidate the "heart-brain axis" mechanism underlying HF-related cognitive disorders.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart Failure Patients group | – | Behavioral: breathing trainingenrolled NYHA II-IV level heart failure patients |
| Healthy Control group | – | Behavioral: breathing trainingconfirmed to have no ischemic heart disease by physical examination and echocardiography, will be recruited. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- NYHA classification II=IV heart failure patients and age- and sex-matched control group
Key inclusion criteria (1 listed)
- Aged >18 years and <70 years. (2)Hospitalized for HF or clinically diagnosed with HF and admitted as an inpatient
Key exclusion criteria (1 listed)
- (1)Concurrent severe non-cardiac oxygen metabolism diseases (e.g., severe Chronic Obstructive Pulmonary Disease (COPD) or end-stage renal failure). (2)Myocardial infarction or stroke within the last 90 days. (3)Contraindications to MRI. (4)Inability to cooperate with the examinations
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 |
|---|---|---|
| breathing trainingBefore MRI scanning, participant will trained to exhale and hold their breath | Behavioural | Healthy Control group, Heart Failure Patients group |
Primary outcome
Cognitive function decline
Time frame: Within after MRI scanning 24 hours
The MoCA scoreless than 26 points is considered to indicate cognitive dysfunction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Heart Failure (HF), run by Yan'an Affiliated Hospital of Kunming Medical University at 1 site in China.
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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 20 Mar 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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?
Cognitive function decline (time frame: Within after MRI scanning 24 hours). 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 20 Mar 2026.