Actively Recruiting
Digital Out-of-hospital Management on Clinical Outcomes in Patients With Early Cardiogenic Shock
Led by Renmin Hospital of Wuhan University · Updated on 2025-07-25
472
Participants Needed
1
Research Sites
214 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Digital Out-of-hospital Management on Clinical Outcomes in Patients With Early Cardiogenic Shock
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with early-stage cardiogenic shock, classified as SCAI stage A, B, or C during hospitalization
- For SCAI stage A: no signs of shock but with extensive myocardial infarction or concurrent acute heart failure
- For SCAI stage B-C: systolic blood pressure between 60 and 90 mmHg or mean arterial pressure between 50 and 60 mmHg or a significant drop in blood pressure lasting more than 30 minutes; or heart rate to systolic blood pressure ratio greater than 1 lasting more than 30 minutes
- Highest arterial blood lactate during hospitalization less than 5 mmol/L
- Stable clinical symptoms at discharge defined as systolic blood pressure 90 mmHg or higher without vasoactive drugs and no signs or symptoms of shock
- Able to understand and willing to sign informed consent and follow the study protocol
You will not qualify if you...
- Unable to use a smartphone for out-of-hospital management despite training
- Discharged due to treatment withdrawal or transfer to another hospital
- Previous or current hospital admission due to cardiac arrest
- Refractory cardiogenic shock
- Refractory heart failure (Stage D according to ACC/AHA guidelines)
- Left ventricular ejection fraction less than 30%
- Estimated glomerular filtration rate less than 25 ml/min or on dialysis
- Severe liver failure (Child-Pugh class C)
- Severe chronic obstructive pulmonary disease requiring long-term oxygen or corticosteroids
- History of cardiac surgery
- Pregnant or breastfeeding women
- Malignant tumors or other serious diseases with life expectancy under 1 year
- Neuropsychiatric disorders preventing cooperation with management
- Participation in other clinical trials within the past year
- Other conditions judged inappropriate for the study by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Actively Recruiting
Research Team
C
Chen jing, doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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