Heart FailureNCT06947148
The Impact of Comprehensive Post Hospital Management Based on DHI on Cardiac Function in Patients With HF
A study testing Comprehensive post hospital management based on digital health intervention(DHI) in people with Heart Failure, run by Harbin Medical University at 1 site in China.
Trial summary
Due to the complex nature of HF patients' conditions, long-term treatment and management are required, especially post hospital management, which is of great significance for improving patients' cardiac function and quality of life. 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?
- Comprehensive post hospital management based on digital health intervention(DHI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 15 Feb 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
- Patients hospitalized for HF, NYHA classification II-IV upon admission
- The patient's residence is within the urban area of each center, and ReDS™ technology can be performed at home or at the outpatient clinic
- No difficulty using smartphones, with basic Chinese reading and writing skills
- Accept the terms and conditions of the study and obtain informed consent from the subjects/their families
Who cannot join
- Age<21 years old
- Patients with height<155 cm or>190 cm, BMI<22 kg/m2 or>36 kg/m2, chest circumference<80 cm or>115 cm, and flail chest or rib fractures
- History of pulmonary embolism
- chronic renal failure（Scr > 443umol/L）
- History of heart transplantation or pacemaker implantation
- Severe pulmonary hypertension
Show all 14Show fewer
- Suffering from end-stage chronic obstructive pulmonary disease, requiring home oxygen therapy
- Massive pleural effusion
- The subject is unable to complete the 6-minute walking test
- Expected lifespan<6 months
- Researchers believe that participants are not suitable to participate in this trial (such as pregnancy, severe visual or hearing impairment, etc.)
- Individuals who are unable to understand and/or comply with this research procedure (such as those who are addicted to alcohol, substance abuse, or have mental illnesses)
- Currently participating in clinical trials of other devices or drugs
- Researchers involved in the design and execution of this study
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000
About this study
Official title: The Impact of Comprehensive Post Hospital Management Based on Digital Health Intervention on Cardiac Function in Patients With Heart Failure: a Prospective, Multicenter, Randomized Controlled Study
Due to the complex nature of HF patients' conditions, long-term treatment and management are required, especially post hospital management, which is of great significance for improving patients' cardiac function and quality of life. With the increasing popularity of smartphones and the continuous development of medical technology, digital health intervention (DHI) has emerged as a new medical model in the treatment of diseases.
This study will establish a comprehensive post hospital management model of HF based on DHI, including cognitive behavioral therapy, digital self-monitoring and remote dielectric sensing (ReDS™) technology, etc., comprehensively strengthen the post hospital intervention and management of HF. Objective to explore the effect of comprehensive post hospital management based on DHI on cardiac function of patients with HF 6 months after discharge.
- Conditions
- Heart Failure
- Being tested
- Comprehensive post hospital management based on digital health intervention(DHI)
- Keywords
- Heart Failure, Digital Health Intervention, Remote Dielectric Sensing, ReDS™, Comprehensive Health Care, 6 Min Walk Test, Randomized Controlled Trial
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive post hospital management based on digital health intervention(DHI)Other
Based on the routine HF management of standard of care (SOC), the intervention group will carry out comprehensive post hospital management based on DHI, including cognitive behavioral therapy, digital self-monitoring and ReDS™ technology, etc.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive post hospital management group | Other | Based on the routine HF management of standard of care (SOC), the intervention group will carry out comprehensive post hospital management based on DHI, including cognitive behavioral therapy, digital self-monitoring and ReDS™ technology, etc. Receives: Other: Comprehensive post hospital management based on digital health intervention(DHI) |
| Routine Management Group | No intervention | The routine management group will accept the routine HF management of SOC throughout the course, and the doctor will carry out treatment and management according to the actual clinical situation, including pre discharge education, precautions for commonly used drugs, guidance for daily life activities, etc. |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk test
Improvement in 6-minute walk test after discharge for 6 months
Measured: The 6th month after discharge
Secondary outcomes (9)
Quality of life index (QLI) rating
Measured: The 1st ,3rd and 6th months after discharge
Kansas city cardiomyopathy questionnaire (KCCQ-23) rating
Measured: The 1st ,3rd and 6th months after discharge
NYHA classification
Measured: The 1st ,3rd and 6th months after discharge
Left ventricular ejection fraction (LVEF)
Measured by echocardiography
Measured: The 6th month after discharge
Number of readmissions for heart failure
Number of readmissions for hospitalized patients with heart failure due to worsening heart failure after discharge
Measured: Within 6 months after discharge
All-cause mortality
Measured: Within 6 months after discharge
Cardiac death
Any death caused by heart disease (such as myocardial infarction, low output HF, fatal arrhythmia), death without witnesses, death from unknown causes, and all surgery related deaths, including those related to concurrent treatment, are classified as cardiac death
Measured: Within 6 months after discharge
Composite endpoint of all-cause death or readmission due to heart failure
Measured: Within 6 months after discharge
Time to first hospitalization for heart failure from baseline
Measured: Within 6 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start1 Apr 2025
- Primary completion18 Jul 2025
- Study completion15 Feb 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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Bo, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947148
- Sponsor's protocol ID
- KY2024-024
- Status last verified
- Mar 2026
- First submitted
- 21 Apr 2025
- Last updated
- 4 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Comprehensive Post Hospital Management Based on Digital Health Intervention on Cardiac Function in Patients With Heart Failure: a Prospective, Multicenter, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06947148
- Acronym / sponsor ID
- KY2024-024
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Digital Health Intervention, Remote Dielectric Sensing, ReDS™, Comprehensive Health Care, 6 Min Walk Test, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 18 Jul 2025 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 27 Apr 2025 (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.
Due to the complex nature of HF patients' conditions, long-term treatment and management are required, especially post hospital management, which is of great significance for improving patients' cardiac function and quality of life. With the increasing popularity of smartphones and the continuous development of medical technology, digital health intervention (DHI) has emerged as a new medical model in the treatment of diseases.
This study will establish a comprehensive post hospital management model of HF based on DHI, including cognitive behavioral therapy, digital self-monitoring and remote dielectric sensing (ReDS™) technology, etc., comprehensively strengthen the post hospital intervention and management of HF. Objective to explore the effect of comprehensive post hospital management based on DHI on cardiac function of patients with HF 6 months after discharge.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive post hospital management group | Other | Other: Comprehensive post hospital management based on digital health intervention(DHI)Based on the routine HF management of standard of care (SOC), the intervention group will carry out comprehensive post hospital management based on DHI, including cognitive behavioral therapy, digital self-monitoring and ReDS™ technology, etc. |
| Routine Management Group | No intervention | –The routine management group will accept the routine HF management of SOC throughout the course, and the doctor will carry out treatment and management according to the actual clinical situation, including pre discharge education, precautions for commonly used drugs, guidance for daily life activities, etc. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients hospitalized for HF, NYHA classification II-IV upon admission
- The patient's residence is within the urban area of each center, and ReDS™ technology can be performed at home or at the outpatient clinic
- No difficulty using smartphones, with basic Chinese reading and writing skills
- Accept the terms and conditions of the study and obtain informed consent from the subjects/their families
Key exclusion criteria (14 listed)
- Age<21 years old
- Patients with height<155 cm or>190 cm, BMI<22 kg/m2 or>36 kg/m2, chest circumference<80 cm or>115 cm, and flail chest or rib fractures
- History of pulmonary embolism
- chronic renal failure（Scr > 443umol/L）
- History of heart transplantation or pacemaker implantation
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 |
|---|---|---|
| Comprehensive post hospital management based on digital health intervention(DHI)Based on the routine HF management of standard of care (SOC), the intervention group will carry out comprehensive post hospital management based on DHI, including cognitive behavioral therapy, digital self-monitoring and ReDS™ technology, etc. | Other | Comprehensive post hospital management group |
Primary outcome
6-minute walk test
Time frame: The 6th month after discharge
Improvement in 6-minute walk test after discharge for 6 months
9 secondary outcomes
Quality of life index (QLI) rating
Time frame: The 1st ,3rd and 6th months after discharge
Kansas city cardiomyopathy questionnaire (KCCQ-23) rating
Time frame: The 1st ,3rd and 6th months after discharge
NYHA classification
Time frame: The 1st ,3rd and 6th months after discharge
Left ventricular ejection fraction (LVEF)
Time frame: The 6th month after discharge
Number of readmissions for heart failure
Time frame: Within 6 months after discharge
All-cause mortality
Time frame: Within 6 months after discharge
Cardiac death
Time frame: Within 6 months after discharge
Composite endpoint of all-cause death or readmission due to heart failure
Time frame: Within 6 months after discharge
Time to first hospitalization for heart failure from baseline
Time frame: Within 6 months after discharge
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 4 Mar 2026.
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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. This study is not recruiting at the moment.
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?
A study testing Comprehensive post hospital management based on digital health intervention(DHI) in people with Heart Failure, run by Harbin 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 4 inclusion and 14 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 4 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?
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?
6-minute walk test (time frame: The 6th month after discharge). 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 4 Mar 2026.