Digital out-of-hospital care for people with early cardiogenic shock

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

This trial tests whether the HeartMed-HF digital out-of-hospital management program can reduce one-year deaths and unplanned hospital readmissions in adults with early cardiogenic shock.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 472 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Renmin Hospital of Wuhan University (Academic / other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT07085221 on ClinicalTrials.gov

What this trial studies

This was a multi-center, open-label, randomized controlled trial that enrolled 472 adults with early-stage cardiogenic shock and randomized them 1:1 to a digital management program or usual discharge guidance. Patients in the experimental arm received the HeartMed-HF digital out-of-hospital management while controls received standard discharge instructions. The co-primary endpoints were all-cause mortality and unplanned readmission at one year (emergency department visits excluded). Secondary endpoints at 3, 6, and 12 months included all-cause mortality, heart failure rehospitalization, recurrent MI, ischemia-driven repeat revascularization, stroke, BARC 3–5 major bleeding, unplanned formal rehospitalization, and guideline-directed medical therapy (GDMT) medication or target-dose achievement. Eligible participants were adults (≥18 years) meeting criteria for early cardiogenic shock (SCAI stage A–C) during hospitalization.

Who should consider this trial

Good fit: Adults aged 18 or older who were hospitalized with early cardiogenic shock (SCAI stage A, B, or C) as defined by the trial enrollment criteria are the intended candidates.

Not a fit: Patients with more advanced or refractory shock (e.g., SCAI stage D/E), those who cannot use or access the digital program, or those requiring ongoing inpatient advanced support are unlikely to benefit from this outpatient-focused intervention.

Why it matters

Potential benefit: If successful, this approach could reduce one-year mortality and unplanned readmissions by enabling earlier post-discharge monitoring and medication optimization.

How similar studies have performed: Remote-monitoring and digital management programs for chronic heart failure have shown mixed benefits for readmission reduction, but applying digital out-of-hospital management specifically to early cardiogenic shock is relatively novel with limited prior evidence.

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.

Where this trial is running

Wuhan, Hubei

• Renmin Hospital of Wuhan University — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Chen jing, doctor

Conditions Shock, Cardiogenic; Shock