Digital Out-of-hospital Management on Clinical Outcomes in Patients With Early Cardiogenic Shock
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRenmin Hospital of Wuhan University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years old;
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)
SBP ≥ 90 mmHg when vasoactive drugs are not used;
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
hospital external management
Combination 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
Treatment groups
472 Participants
are divided into 2 treatment groupsGroup A: conventional management groupNo intervention 0 interventions
Group B: hospital external managementExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 months2
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 monthsSecondary outcomes
1
all-cause mortality
Time frame
From enrollment to the end of management up to 12 months2
Rehospitalization for HF
Time frame
From enrollment to the end of management up to 12 months3
Recurrent MI
Time frame
From enrollment to the end of management up to 12 months4
Ischemia-driven repeat revascularization
Time frame
From enrollment to the end of management up to 12 monthsSponsors and contacts
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Source ClinicalTrials.gov