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NCT07085221Recruiting

Digital Out-of-hospital Management on Clinical Outcomes in Patients 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

Source: ClinicalTrials.gov · Last updated 17 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
472 (estimated)
First submitted
14 Jul 2025
Start date
26 Jul 2025
Primary completion date
31 Dec 2027
Lead sponsor
Renmin Hospital of Wuhan University
NCT number
NCT07085221

What you commit to

  • Study type: Interventional
  • Planned participants: 472
  • From 26 Jul 2025 to the primary completion date, 31 Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • The reasons for discharge were treatment withdrawal and transfer to another hospital for continued therapy
  • Previous or current hospital admission due to cardiac arrest

Other illness

  • Refractory Heart Failure (ACC/AHA guidelines Stage D heart Failure)
  • 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
  • Combined with malignant tumors and other serious diseases, the expected life span is less than 1 year
  • Neuropsychiatric disorders, unable to cooperate with management;

Lab values

  • Left ventricular ejection fraction \< 30%

Other

  • Unable to use a smartphone for out-of-hospital management despite training
  • Refractory cardiogenic shock
  • (Estimated) glomerular filtration rate \< 25 ml/min or on dialysis
  • Pregnant or lactating women
  • Participation in other clinical trials within the past year;
  • Other circumstances considered to be inappropriate for this study by the investigator.

Who the study is looking for

  • 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)
    • 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:
  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Renmin Hospital of Wuhan University
Coordinator of this site? Confirm its status
WuhanChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.