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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Renmin Hospital of Wuhan University
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Chen jing, doctor
• Email: 364580342@qq.com
• Phone: +86 13659840327

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.