Shock, CardiogenicDIGI-CSNCT07085221
Digital Out-of-hospital Management on Clinical Outcomes in Patients With Early Cardiogenic Shock
A study testing hospital external management in people with Shock, Cardiogenic and Shock, run by Renmin Hospital of Wuhan University at 1 site in China.
Trial summary
This clinical study was a multi-center, open-label, randomized controlled clinical trial. A total of 472 patients with early-stage cardiogenic shock were recruited and randomly divided into the experimental group and the control group, with 236 cases in each group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock, Cardiogenic, Shock
- What is being tested?
- hospital external management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 472 participants
- Where
- 1 siteChina
- Study dates
- 26 Jul 2025to 31 Dec 2028
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥ 18 years old;
- The patient meets the diagnosis of early-stage cardiogenic shock, with SCAI stage A, B, or C during hospitalization; (1) SCAI stage A:
- Without signs of shock and meeting one of the following criteria:
- Combined with extensive myocardial infarction, diagnosed as widespread anterior wall myocardial infarction based on ST-segment elevation in ECG leads (V1-V5, aVL, I leads), inferior wall combined with right ventricular (II, III, aVF, V3R-V5R leads) and/or posterior wall myocardial infarction (V7-V9 leads), or recurrent myocardial infarction within 28 days.
- Concurrent acute heart failure or acute exacerbation of chronic heart failure. (2) SCAI stage B-C (meeting the following conditions)
- 1) 60 < SBP < 90 mmHg or mean arterial blood pressure 50 < MAP < 60 mmHg or a decrease of > 30 mmHg from baseline lasting 30 minutes; or SBP ≥ 90 mmHg but heart rate /SBP > 1 lasting > 30 minutes.
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- 2) The highest arterial blood lactate during hospitalization < 5 mmol/L. 3. Stable clinical symptoms at discharge, defined as:
- SBP ≥ 90 mmHg when vasoactive drugs are not used;
- No signs and symptoms of shock. 4. Understand and be willing to sign the informed consent, and be willing to follow the treatment and visit plan required by the protocol.
Who cannot join
- Unable to use a smartphone for out-of-hospital management despite training
- The reasons for discharge were treatment withdrawal and transfer to another hospital for continued therapy
- Previous or current hospital admission due to cardiac arrest
- Refractory cardiogenic shock
- Refractory Heart Failure (ACC/AHA guidelines Stage D heart Failure)
- Left ventricular ejection fraction < 30%
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- (Estimated) glomerular filtration rate < 25 ml/min or on dialysis
- Severe hepatic insufficiency (Child-Pugh class C)
- Severe chronic obstructive pulmonary disease (confirmed by pulmonary function tests, or requiring long-term home oxygen therapy or long-term use of corticosteroids)
- History of cardiac surgery
- Pregnant or lactating women
- Combined with malignant tumors and other serious diseases, the expected life span is less than 1 year
- Neuropsychiatric disorders, unable to cooperate with management;
- Participation in other clinical trials within the past year;
- Other circumstances considered to be inappropriate for this study by the investigator.
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, 1 recruiting
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei
Chen Jing, doctor, +86 13659840327, Chenjing1982@whu.edu.cn
About this study
Official title: Digital Out-of-hospital Management on Clinical Outcomes in Patients With Early Cardiogenic Shock: a Multi-center, Randomized Controlled Clinical Trial
This clinical study was a multi-center, open-label, randomized controlled clinical trial. A total of 472 patients with early-stage cardiogenic shock were recruited and randomly divided into the experimental group and the control group, with 236 cases in each group. The HeartMed-HF digital out-of-hospital management was used to manage the patients in the experimental group, while the patients in the control group were managed according to the discharge guidance. The primary endpoints were 1-year all-cause mortality and unplanned readmission after randomization (excluding emergency department visits). Secondary endpoints (at 3 months, 6 months, and 12 months post-randomization) were: all-cause mortality, rehospitalization for HF, recurrent MI, ischemia-driven repeat revascularization, stroke, BARC 3-5 grade major bleeding, unplanned formal rehospitalization, types of GDMT medications or GDMT target dose achievement rate.
- Conditions
- Shock, Cardiogenic, Shock
- Being tested
- hospital external management
- Medical subject headings
- Shock, Cardiogenic, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hospital external managementCombination product
(I) Symptom management: After enrollment, health managers regularly promoted health education to enhance patients' awareness of the disease and adherence to post-discharge management. Simultaneously, patients were managed via a digital platform, with each patient being provided with a chip-implanted sphygmomanometer to monitor their blood pressure and pulse in real time. If patients develop symptoms, they can report them in real-time and generate alerts to health managers. Through internal clinical decision-making algorithms, the telemedicine team would conduct clinical evaluations and seek decision guidance from clinical cardiologists if necessary.
(II) Clinical evaluation: the system stratified patients by risk levels and determined the frequency and intensity of management accordingly, with blood pressure and heart rate monitored daily. The digital management system automatically transmitted abnormal data to a doctor's assistant, with early detection of life-threatening complication
| Study group | Role | What they receive |
|---|---|---|
| conventional management group | No intervention | Not described |
| hospital external management | Experimental | Not described Receives: Combination Product: hospital external management |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year all-cause mortality and unplanned formal readmission after randomization (excluding emergency department visits)
Measured: From enrollment to the end of management up to 12 months
1-year all-cause mortality and unplanned formal readmission after randomization (excluding emergency department visits)
Time to first event analysis: Event rates will be estimated by the Kaplan Meier method and compared by the log rank test. Treatment effects will be assessed using Cox regression, with results expressed as hazard ratios (HRs) and 95% CIs.
Measured: from enrollment to the end of treatment at 12 months
Secondary outcomes (9)
all-cause mortality
Measured: From enrollment to the end of management up to 12 months
Rehospitalization for HF
Measured: From enrollment to the end of management up to 12 months
Recurrent MI
Measured: From enrollment to the end of management up to 12 months
Ischemia-driven repeat revascularization
Measured: From enrollment to the end of management up to 12 months
Stroke
Measured: From enrollment to the end of management up to 12 months
Bleeding Academic Research Consortium 3-5 grade
BARC Bleeding Classification
- Type 0
No evidence of bleeding.
- Type 1
Mild bleeding requiring no medical intervention (e.g., patient self-discontinues medication without seeking medical attention).
- Type 2
Overt bleeding necessitating medical intervention (e.g., medication adjustment, hospitalization, or evaluation) but not meeting criteria for higher grades.
Examples: Subcutaneous bruising, epistaxis, or minor gastrointestinal bleeding.
- Type 3
- 3a: Hemoglobin drop of 3-5 g/dL or requiring transfusion;
- 3b: Hemoglobin drop ≥5 g/dL, cardiac tamponade, need for surgical hemostasis, or vasoactive drugs;
- 3c: Intracranial hemorrhage or intraocular bleeding causing visual impairment.
- Type 4
CABG-related bleeding (e.g., postoperative reoperation or massive transfusion).
- Type 5
- 5a: Clinically suspected fatal bleeding
Measured: From enrollment to the end of management up to 12 months
Unplanned formal rehospitalization
Measured: From enrollment to the end of management up to 12 months
Types of GDMT medications
Measured: From enrollment to the end of management up to 12 months
GDMT target dose achievement rate
Measured: From enrollment to the end of management up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start26 Jul 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shock, CardiogenicStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group: digital out-of-hospital management Control group: routine outpatient follow-up
- Masking
- None (open label)
- Enrolment
- 472 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Jing, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085221
- Sponsor's protocol ID
- WDRY2024-K234
- Acronym
- DIGI-CS
- Status last verified
- Jun 2026
- First submitted
- 14 Jul 2025
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Out-of-hospital Management on Clinical Outcomes in Patients With Early Cardiogenic Shock: a Multi-center, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07085221
- Acronym / sponsor ID
- DIGI-CS / WDRY2024-K234
- Conditions
- Shock, Cardiogenic, Shock
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 472 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Study start
- 26 Jul 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 25 Jul 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.
This clinical study was a multi-center, open-label, randomized controlled clinical trial. A total of 472 patients with early-stage cardiogenic shock were recruited and randomly divided into the experimental group and the control group, with 236 cases in each group. The HeartMed-HF digital out-of-hospital management was used to manage the patients in the experimental group, while the patients in the control group were managed according to the discharge guidance. The primary endpoints were 1-year all-cause mortality and unplanned readmission after randomization (excluding emergency department visits). Secondary endpoints (at 3 months, 6 months, and 12 months post-randomization) were: all-cause mortality, rehospitalization for HF, recurrent MI, ischemia-driven repeat revascularization, stroke, BARC 3-5 grade major bleeding, unplanned formal rehospitalization, types of GDMT medications or GDMT target dose achievement rate.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental group: digital out-of-hospital management Control group: routine outpatient follow-up
| Arm | Type | Receives |
|---|---|---|
| conventional management group | No intervention | – |
| hospital external management | Experimental | Combination Product: hospital external management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years old;
- The patient meets the diagnosis of early-stage cardiogenic shock, with SCAI stage A, B, or C during hospitalization; (1) SCAI stage A:
- Combined with extensive myocardial infarction, diagnosed as widespread anterior wall myocardial infarction based on ST-segment elevation in ECG leads (V1-V5, aVL, I leads), inferior wall combined with right ventricular (II, III, aVF, V3R-V5R leads) and/or posterior wall myocardial infarction (V7-V9 leads), or recurrent myocardial infarction within 28 days.
- Concurrent acute heart failure or acute exacerbation of chronic heart failure. (2) SCAI stage B-C (meeting the following conditions)
- 1) 60 < SBP < 90 mmHg or mean arterial blood pressure 50 < MAP < 60 mmHg or a decrease of > 30 mmHg from baseline lasting 30 minutes; or SBP ≥ 90 mmHg but heart rate /SBP > 1 lasting > 30 minutes.
Key exclusion criteria (15 listed)
- Unable to use a smartphone for out-of-hospital management despite training
- The reasons for discharge were treatment withdrawal and transfer to another hospital for continued therapy
- Previous or current hospital admission due to cardiac arrest
- Refractory cardiogenic shock
- Refractory Heart Failure (ACC/AHA guidelines Stage D heart Failure)
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 |
|---|---|---|
| hospital external management(I) Symptom management: After enrollment, health managers regularly promoted health education to enhance patients' awareness of the disease and adherence to post-discharge management. Simultaneously, patients were managed via a digital platform, with each patient being provided with a chip-implanted sphygmomanometer to monitor their blood pressure and pulse in real time. If patients develop symptoms, they can report them in real-time and generate alerts to health managers. Through internal clinical decision-making algorithms, the telemedicine team would conduct clinical evaluations and seek decision guidance from clinical cardiologists if necessary. (II) Clinical evaluation: the system stratified patients by risk levels and determined the frequency and intensity of management accordingly, with blood pressure and heart rate monitored daily. The digital management system automatically transmitted abnormal data to a doctor's assistant, with early detection of life-threatening complication | Combination product | hospital external management |
Primary outcome
1-year all-cause mortality and unplanned formal readmission after randomization (excluding emergency department visits)
Time frame: From enrollment to the end of management up to 12 months
1-year all-cause mortality and unplanned formal readmission after randomization (excluding emergency department visits)
Time frame: from enrollment to the end of treatment at 12 months
Time to first event analysis: Event rates will be estimated by the Kaplan Meier method and compared by the log rank test. Treatment effects will be assessed using Cox regression, with results expressed as hazard ratios (HRs) and 95% CIs.
9 secondary outcomes
all-cause mortality
Time frame: From enrollment to the end of management up to 12 months
Rehospitalization for HF
Time frame: From enrollment to the end of management up to 12 months
Recurrent MI
Time frame: From enrollment to the end of management up to 12 months
Ischemia-driven repeat revascularization
Time frame: From enrollment to the end of management up to 12 months
Stroke
Time frame: From enrollment to the end of management up to 12 months
Bleeding Academic Research Consortium 3-5 grade
Time frame: From enrollment to the end of management up to 12 months
Unplanned formal rehospitalization
Time frame: From enrollment to the end of management up to 12 months
Types of GDMT medications
Time frame: From enrollment to the end of management up to 12 months
GDMT target dose achievement rate
Time frame: From enrollment to the end of management up to 12 months
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 Jun 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hospital external management in people with Shock, Cardiogenic and Shock, run by Renmin Hospital of Wuhan 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 9 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 17 Jun 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?
Contact Chen jing, doctor (+86 13659840327, 364580342@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year all-cause mortality and unplanned formal readmission after randomization (excluding emergency department visits) (time frame: From enrollment to the end of management up to 12 months). The study lists 2 primary outcomes in all. 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 Jun 2026.