Heart FailureNCT06444425
Artificial Intelligence in Detecting Cardiac Function
An observational study of Heart Failure and Deep Learning, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
The Korotkoff Sounds（KS）, which have been in use for over a century, are widely regarded as the gold standard for measuring blood pressure. Furthermore, their potential extends beyond diagnosis and treatment of cardiovascular disease; however, research on the KS remains limited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Deep Learning
- How many people
- 685 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 31 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were admitted to the Cardiology Department of the aforementioned four Groups (The Fourth Affiliated Hospital of School of Medicine of Zhejiang University, Zhejiang Taizhou Hospital, Quzhou People\'s Hospital, Zhejiang Quhua Hospital) between June 2024 and December 2024, and successfully underwent echocardiographic examinations.
Who may be able to join
- Patients who were admitted to the Cardiology Department of the aforementioned four Groups (The Fourth Affiliated Hospital of School of Medicine of Zhejiang University, Zhejiang Taizhou Hospital, Quzhou People\'s Hospital, Zhejiang Quhua Hospital)between June 2024 and December 2024, and successfully underwent echocardiographic examinations.
- Individuals aged between 18 and 90 years with a resting heart rate ranging from 60 to 100 beats per minute.
- Demonstrating good compliance, capable of cooperating in completing multiple blood pressure measurements within 72 hours following the completion of echocardiography.
- Willingness to voluntarily participate in the study.
Who cannot join
- Patients with acute decompensated heart failure, acute myocardial infarction, atrioventricular block;
- Cerebral hemorrhage, severe infection, active digestive tract ulcer, severe hematological diseases, severe liver and kidney dysfunction or other serious medical or surgical conditions;
- Pregnant or lactating women;
- Patients with mental illness;
- Individuals who have participated in other clinical trials within the past 3 months.
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
The Fourth Hospital Affiliated to Zhejiang University School of Medicine
Yiwu, Zhejiang, 322000
About this study
Official title: Korotkoff Sounds Dynamically Reflect Changes in Cardiac Function Based on Deep Learning Methods: A Prospective, Multicenter Study
The Korotkoff Sounds（KS）, which have been in use for over a century, are widely regarded as the gold standard for measuring blood pressure. Furthermore, their potential extends beyond diagnosis and treatment of cardiovascular disease; however, research on the KS remains limited. Given the increasing incidence of heart failure (HF), there is a pressing need for a rapid and convenient prehospital screening method. In this study, we propose employing deep learning (DL) techniques to explore the feasibility of utilizing KS methodology in predicting functional changes in cardiac ejection fraction (LVEF) as an indicator of cardiac dysfunction.
Read the detailed description
Blood Pressure Measurement：Around 72 hours before and after the completion of the patient\'s echocardiogram, considering the variability in the patient\'s blood pressure and ejection fraction at different times, blood pressure should be measured in each participant at least twice a day, up to a maximum of six times. Each patient should be instructed to remain in a quiet state for 10 minutes before blood pressure measurement. Blood pressure measurement should be conducted according to the following criteria: the cuff used to measure blood pressure should be wrapped around the patient\'s arm above the elbow joint, positioned 2-3 cm above the level of the heart, with a snugness that allows one finger to fit underneath. Place the stethoscope head at the brachial artery pulse point on the left elbow joint, then begin inflation. Inflate continuously until the sound of the pulse beat disappears; then inflate an additional 20 mmHg before stopping inflation. Slowly deflate while listening-the first audible pulse beat is the systolic pressure, and the disappearance of the pulse sound is the diastolic pressure. Use the Hanhong POPULAR-3 electronic stethoscope to record the aforementioned process, with each audio recording lasting 25 seconds uniformly.
Data Analysis Overview:
In terms of data analysis, deep learning models are developed based on Torch version 1.5.0, utilizing Transformer network architecture to analyze the collected audio data.
Network One: Identifying the presence of cardiac functional abnormalities through Korotkoff sounds.
Evaluation Metrics: Receiver Operating Characteristic (AUROC), sensitivity, specificity, and F1 score (harmonic mean of sensitivity and specificity) to assess model performance on the test dataset.
Network Two: NYHA classification of Korotkoff sounds. Evaluation Metrics: Confusion matrix, weighted accuracy, multi-class ROC curve, F1 score.
Network Three: Heart failure classification of Korotkoff sounds in heart failure patients.
Evaluation Metrics: Confusion matrix, weighted accuracy, multi-class ROC curve, F1 score.
Network Four: Left Ventricular Ejection Fraction (LVEF) prediction from Korotkoff sounds.
Evaluation Metrics: Root Mean Squared Error (RMSE), Mean Absolute Error (MAE), Mean Squared Error (MSE), R2 Score.
- Conditions
- Heart Failure, Deep Learning
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure | Patients with stable heart failure were defined as those with structural heart disease and a history of heart failure episodes but no current symptoms or signs of heart failure after receiving anti-heart failure treatment during hospitalization, such as decreased exercise tolerance (dyspnea, fatigue), fluid retention, etc. Additionally, according to the 2024 Chinese guidelines for the diagnosis and treatment of heart failure consensus, patients eligible for this study will be classified based on ejection fraction into the following categories: * Reduced ejection fraction heart failure (HFrEF): HFrEF is defined by LVEF < 40% * Preserved ejection fraction heart failure (HFpEF): HFpEF is defined by LVEF ≥ 50% * Heart failure with mid-range ejection fraction (HFmrEF): HFmrEF refers to heart failure characterized by LVEF between 40% and 49%. | |
| Normal | There were no structural or functional abnormalities in the cardiac system, and no symptoms or signs of heart failure were observed. Alternatively, the patient has developed organic heart disease without exhibiting any symptoms or signs of heart failure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Dysfunction
The pathophysiology of heart failure encompasses a multifaceted clinical syndrome: 1)Cardiac structural and/or functional abnormalities resulting in impaired ventricular diastolic function and/or systolic ejection capacity;2)Corresponding clinical manifestations indicative of heart failure; 3)Typically accompanied by elevated levels of beneficial natriuretic peptide(BNP), as well as pulmonary or systemic congestion suggestive of cardiac origin on imaging studies, or objective evidence of increased ventricular filling pressure on hemodynamic assessments.4)According to the classification of left ventricular ejection fraction (LVEF) based on cardiac ultrasound, heart failure can be categorized into four types: reduced ejection fraction heart failure (HFrEF), improving ejection fraction heart failure (HFimpEF), moderately reduced ejection fraction heart failure (HFmrEF), and retained ejection fraction heart failure (HFpEF).
Measured: Evaluation LVEF：Cardiac ultrasound was performed 72 hours prior to and following anti-Acute Heart Failure treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start1 Jun 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2025 (estimated)
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 685 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Taizhou hospital, The People's Hospital of Quzhou, Zhejiang Quhua Hospital, Hong Kong Applied Science and Technology Research Institute
- Responsible party
- Sponsor
- Investigators
- Sixiang Jia, MD, Study director, The fourth hospital affiliated to zhejiang university school of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444425
- Sponsor's protocol ID
- KY-2024-108
- Status last verified
- Feb 2025
- First submitted
- 31 May 2024
- Last updated
- 17 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Korotkoff Sounds Dynamically Reflect Changes in Cardiac Function Based on Deep Learning Methods: A Prospective, Multicenter Study
- ClinicalTrials.gov ID
- NCT06444425
- Acronym / sponsor ID
- KY-2024-108
- Conditions
- Heart Failure, Deep Learning
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 685 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Collaborators
- Zhejiang Taizhou hospital, The People's Hospital of Quzhou, Zhejiang Quhua Hospital, Hong Kong Applied Science and Technology Research Institute
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Jun 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.
The Korotkoff Sounds（KS）, which have been in use for over a century, are widely regarded as the gold standard for measuring blood pressure. Furthermore, their potential extends beyond diagnosis and treatment of cardiovascular disease; however, research on the KS remains limited. Given the increasing incidence of heart failure (HF), there is a pressing need for a rapid and convenient prehospital screening method. In this study, we propose employing deep learning (DL) techniques to explore the feasibility of utilizing KS methodology in predicting functional changes in cardiac ejection fraction (LVEF) as an indicator of cardiac dysfunction.
Detailed description
Blood Pressure Measurement：Around 72 hours before and after the completion of the patient\&#39;s echocardiogram, considering the variability in the patient\&#39;s blood pressure and ejection fraction at different times, blood pressure should be measured in each participant at least twice a day, up to a maximum of six times. Each patient should be instructed to remain in a quiet state for 10 minutes before blood pressure measurement. Blood pressure measurement should be conducted according to the following criteria: the cuff used to measure blood pressure should be wrapped around the patient\&#39;s arm above the elbow joint, positioned 2-3 cm above the level of the heart, with a snugness that allows one finger to fit underneath. Place the stethoscope head at the brachial artery pulse point on the left elbow joint, then begin inflation. Inflate continuously until the sound of the pulse beat disappears; then inflate an additional 20 mmHg before stopping inflation. Slowly deflate while listening-the first audible pulse beat is the systolic pressure, and the disappearance of the pulse sound is the diastolic pressure. Use the Hanhong POPULAR-3 electronic stethoscope to record the aforementioned process, with each audio recording lasting 25 seconds uniformly.
Data Analysis Overview:
In terms of data analysis, deep learning models are developed based on Torch version 1.5.0, utilizing Transformer network architecture to analyze the collected audio data.
Network One: Identifying the presence of cardiac functional abnormalities through Korotkoff sounds.
Evaluation Metrics: Receiver Operating Characteristic (AUROC), sensitivity, specificity, and F1 score (harmonic mean of sensitivity and specificity) to assess model performance on the test dataset.
Network Two: NYHA classification of Korotkoff sounds. Evaluation Metrics: Confusion matrix, weighted accuracy, multi-class ROC curve, F1 score.
Network Three: Heart failure classification of Korotkoff sounds in heart failure patients.
Evaluation Metrics: Confusion matrix, weighted accuracy, multi-class ROC curve, F1 score.
Network Four: Left Ventricular Ejection Fraction (LVEF) prediction from Korotkoff sounds.
Evaluation Metrics: Root Mean Squared Error (RMSE), Mean Absolute Error (MAE), Mean Squared Error (MSE), R2 Score.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart Failure | – | –Patients with stable heart failure were defined as those with structural heart disease and a history of heart failure episodes but no current symptoms or signs of heart failure after receiving anti-heart failure treatment during hospitalization, such as decreased exercise tolerance (dyspnea, fatigue), fluid retention, etc. Additionally, according to the 2024 Chinese guidelines for the diagnosis and treatment of heart failure consensus, patients eligible for this study will be classified based on ejection fraction into the following categories: * Reduced ejection fraction heart failure (HFrEF): HFrEF is defined by LVEF < 40% * Preserved ejection fraction heart failure (HFpEF): HFpEF is defined by LVEF ≥ 50% * Heart failure with mid-range ejection fraction (HFmrEF): HFmrEF refers to heart failure characterized by LVEF between 40% and 49%. |
| Normal | – | –There were no structural or functional abnormalities in the cardiac system, and no symptoms or signs of heart failure were observed. Alternatively, the patient has developed organic heart disease without exhibiting any symptoms or signs of heart failure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were admitted to the Cardiology Department of the aforementioned four Groups (The Fourth Affiliated Hospital of School of Medicine of Zhejiang University, Zhejiang Taizhou Hospital, Quzhou People\&#39;s Hospital, Zhejiang Quhua Hospital) between June 2024 and December 2024, and successfully underwent echocardiographic examinations.
Key inclusion criteria (4 listed)
- Patients who were admitted to the Cardiology Department of the aforementioned four Groups (The Fourth Affiliated Hospital of School of Medicine of Zhejiang University, Zhejiang Taizhou Hospital, Quzhou People\&#39;s Hospital, Zhejiang Quhua Hospital)between June 2024 and December 2024, and successfully underwent echocardiographic examinations.
- Individuals aged between 18 and 90 years with a resting heart rate ranging from 60 to 100 beats per minute.
- Demonstrating good compliance, capable of cooperating in completing multiple blood pressure measurements within 72 hours following the completion of echocardiography.
- Willingness to voluntarily participate in the study.
Key exclusion criteria (5 listed)
- Patients with acute decompensated heart failure, acute myocardial infarction, atrioventricular block;
- Cerebral hemorrhage, severe infection, active digestive tract ulcer, severe hematological diseases, severe liver and kidney dysfunction or other serious medical or surgical conditions;
- Pregnant or lactating women;
- Patients with mental illness;
- Individuals who have participated in other clinical trials within the past 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiac Dysfunction
Time frame: Evaluation LVEF：Cardiac ultrasound was performed 72 hours prior to and following anti-Acute Heart Failure treatment.
The pathophysiology of heart failure encompasses a multifaceted clinical syndrome: 1)Cardiac structural and/or functional abnormalities resulting in impaired ventricular diastolic function and/or systolic ejection capacity;2)Corresponding clinical manifestations indicative of heart failure; 3)Typically accompanied by elevated levels of beneficial natriuretic peptide(BNP), as well as pulmonary or systemic congestion suggestive of cardiac origin on imaging studies, or objective evidence of increased ventricular filling pressure on hemodynamic assessments.4)According to the classification of left ventricular ejection fraction (LVEF) based on cardiac ultrasound, heart failure can be categorized into four types: reduced ejection fraction heart failure (HFrEF), improving ejection fraction heart failure (HFimpEF), moderately reduced ejection fraction heart failure (HFmrEF), and retained ejection fraction heart failure (HFpEF).
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 17 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Sixiang Jia, MD study director
The fourth hospital affiliated to zhejiang university school of medicine
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 and Deep Learning, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine 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 4 inclusion and 5 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 17 Feb 2025. 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?
Cardiac Dysfunction (time frame: Evaluation LVEF：Cardiac ultrasound was performed 72 hours prior to and following anti-Acute Heart Failure 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 Feb 2025.