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

NCT ID: NCT07085221

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 472 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-19
• Study Completion Date: 2028-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

conventional management group

Group Type: NO_INTERVENTION

No interventions assigned to this group

hospital external management

Group Type: EXPERIMENTAL

hospital external management

Intervention Type: 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

Interventions

hospital external management

(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

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years old;

2. 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:

1. 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.

2. Concurrent acute heart failure or acute exacerbation of chronic heart failure. (2) SCAI stage B-C (meeting the following conditions)

1) 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.

2) The highest arterial blood lactate during hospitalization < 5 mmol/L. 3. Stable clinical symptoms at discharge, defined as:

1. SBP ≥ 90 mmHg when vasoactive drugs are not used;

2. 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

1. Unable to use a smartphone for out-of-hospital management despite training

2. The reasons for discharge were treatment withdrawal and transfer to another hospital for continued therapy

3. Previous or current hospital admission due to cardiac arrest

4. Refractory cardiogenic shock

5. Refractory Heart Failure (ACC/AHA guidelines Stage D heart Failure)

6. Left ventricular ejection fraction < 30%

7. (Estimated) glomerular filtration rate < 25 ml/min or on dialysis

8. Severe hepatic insufficiency (Child-Pugh class C)

9. Severe chronic obstructive pulmonary disease (confirmed by pulmonary function tests, or requiring long-term home oxygen therapy or long-term use of corticosteroids)

10. History of cardiac surgery

11. Pregnant or lactating women

12. Combined with malignant tumors and other serious diseases, the expected life span is less than 1 year

13. Neuropsychiatric disorders, unable to cooperate with management;

14. Participation in other clinical trials within the past year;

15. Other circumstances considered to be inappropriate for this study by the investigator.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Renmin Hospital of Wuhan University

OTHER

Sponsor Role: lead

Responsible Party

Chen Jing

Chief of Cardiology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chen jing, doctor

Role: CONTACT

364580342@qq.com

+86 13659840327

Facility Contacts

Chen Jing, doctor

Role: primary

Chenjing1982@whu.edu.cn

+86 13659840327

Other Identifiers

WDRY2024-K234

Identifier Type: -

Identifier Source: org_study_id