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

NCT07085221 | Recruiting DMC

• 1 other identifier: WDRY2024-K234
• Study Type: interventional
• Target: 472
• Locations: 1 country
• Sites: 1

Brief Summary

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

Shock, Cardiogenic; Shock

Outcome Measures

Primary Outcomes (1)

• 1-year all-cause mortality and unplanned formal readmission after randomization (excluding emergency department visits)

  From enrollment to the end of management up to 12 months

Secondary Outcomes (9)

• all-cause mortality

  From enrollment to the end of management up to 12 months

• Rehospitalization for HF

  From enrollment to the end of management up to 12 months

• Recurrent MI

  From enrollment to the end of management up to 12 months

• Ischemia-driven repeat revascularization

  From enrollment to the end of management up to 12 months

• Stroke

  From enrollment to the end of management up to 12 months

Study Arms (2)

conventional management group

NO INTERVENTION

hospital external management

EXPERIMENTAL

Combination Product: hospital external management

Interventions

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

hospital external management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Renmin Hospital of Wuhan University: lead

Study Sites (1)

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

Shock, Cardiogenic; Shock

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Chen jing, doctor

CONTACT

+86 13659840327; 364580342@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Cardiology Department

Model Details: Experimental group: digital out-of-hospital management Control group: routine outpatient follow-up

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 25, 2025
• Study Start: November 19, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 25, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)