A Study on the Correlation Between Cardiac-Cerebral Oxygenation Reserve and Cognitive Function Changes in Heart Failure Patients

NCT07485816 | Enrolling By Invitation DMC

• 1 other identifier: 2025-342-01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Heart Failure (HF)

Keywords

Heart Failure, cardio-cerebral oxygenation reserve, cognitive dysfunction, OS-MRI

Outcome Measures

Primary Outcomes (1)

• Cognitive function decline

  The MoCA scoreless than 26 points is considered to indicate cognitive dysfunction

  Within after MRI scanning 24 hours

Study Arms (2)

Heart Failure Patients group

enrolled NYHA II-IV level heart failure patients

Behavioral: breathing training

Healthy Control group

confirmed to have no ischemic heart disease by physical examination and echocardiography, will be recruited.

Behavioral: breathing training

Interventions

breathing training BEHAVIORAL

Before MRI scanning, participant will trained to exhale and hold their breath

Healthy Control group; Heart Failure Patients group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

NYHA classification II=IV heart failure patients and age- and sex-matched control group

You may qualify if:

• Aged \>18 years and \<70 years. (2)Hospitalized for HF or clinically diagnosed with HF and admitted as an inpatient

You may not qualify if:

• (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

Sponsors & Collaborators

• Yan'an Affiliated Hospital of Kunming Medical University: lead

Study Sites (1)

Yan'an Hospital Affiliated to Kunming Medical University

Kunming, Yunnan, 650051, China

Location

MeSH Terms

Conditions

Heart Failure; Cognitive Dysfunction

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 20, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

CN (1)