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

Wuhan University

Status

Enrolling

Conditions

Shock

Shock, Cardiogenic

Treatments

Combination Product: hospital external management

Study type

Interventional

Funder types

Other

Identifiers

NCT07085221

WDRY2024-K234

Details and patient eligibility

About

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.

Enrollment

472 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.