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NCT Number: NCT07085221

Digital Out-of-hospital Management on Clinical Outcomes in Patients With Early Cardiogenic Shock

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.

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Key information

Conditions

Shock, Cardiogenic Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • 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.
  • 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.

Exclusion criteria

  • 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%
  • (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.

Treatment and study plan

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

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 months

  2. 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.

Secondary outcomes

  1. all-cause mortality

    Time frame: From enrollment to the end of management up to 12 months

  2. Rehospitalization for HF

    Time frame: From enrollment to the end of management up to 12 months

  3. Recurrent MI

    Time frame: From enrollment to the end of management up to 12 months

  4. Ischemia-driven repeat revascularization

    Time frame: From enrollment to the end of management up to 12 months

  5. Stroke

    Time frame: From enrollment to the end of management up to 12 months

  6. Bleeding Academic Research Consortium 3-5 grade

    Time frame: From enrollment to the end of management up to 12 months

    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

  7. Unplanned formal rehospitalization

    Time frame: From enrollment to the end of management up to 12 months

  8. Types of GDMT medications

    Time frame: From enrollment to the end of management up to 12 months

  9. GDMT target dose achievement rate

    Time frame: From enrollment to the end of management up to 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Chen jing, doctor

CONTACT

[email protected]

+86 13659840327

Sponsors and collaborators

Lead sponsor

Renmin Hospital of Wuhan University

Other

Registry information

Official study title

Digital Out-of-hospital Management on Clinical Outcomes in Patients With Early Cardiogenic Shock: a Multi-center, Randomized Controlled Clinical Trial

Acronym: DIGI-CS

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jul 25, 2025
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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