An interventional study of hospital external management in Shock, Cardiogenic and Shock, sponsored by Renmin Hospital of Wuhan University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by Renmin Hospital of Wuhan University · Not applicable, Interventional, and Health services research
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.
296 studies on the registry are indexed under Shock, Cardiogenic; 134 are open to participants now.
This study's planned enrollment of 472 is above the median of 80 across 133 interventional studies indexed under Shock, Cardiogenic.
Browse Shock, Cardiogenic studies →Renmin Hospital of Wuhan University is the lead sponsor of 86 studies on the registry; 29 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Without signs of shock and meeting one of the following criteria:
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.
2) The highest arterial blood lactate during hospitalization \< 5 mmol/L. 3. Stable clinical symptoms at discharge, defined as:
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Combination Product: 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
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 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.
Time frame: from enrollment to the end of treatment at 12 months
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
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
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
Plan to share: No
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Renmin Hospital of Wuhan University