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

Qualifiers

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

Treatments tested in this trial

  • hospital external management

Treatment groups

472 Participants
are divided into 2 treatment groups