Digital Out-of-hospital Management on Clinical Outcomes in Patients With Early Cardiogenic Shock (NCT07085221) | Clinical Trial Compass
RecruitingNot Applicable
Digital Out-of-hospital Management on Clinical Outcomes in Patients With Early Cardiogenic Shock
China472 participantsStarted 2025-07-26
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
. 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)
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial focuses on 'early cardiogenic shock' managed outside the hospital — does my current condition and stage of cardiogenic shock actually match what this study is looking for, and would I be a realistic candidate to discuss with my care team?
2The trial is measuring 1-year all-cause mortality and unplanned hospital readmissions — what does 'digital out-of-hospital management' actually mean in practice for me day-to-day, and how much of my care would shift away from in-person visits?
3Since this is listed as Phase NA, which often applies to non-drug interventions like digital health tools, what is already known about the safety and effectiveness of this type of remote monitoring approach for cardiogenic shock patients, compared to standard in-hospital or clinic-based follow-up?
4If I were enrolled, what happens if my condition worsens while I'm being managed digitally at home — is there a clear protocol for getting me back into the hospital quickly?
5Would you recommend I consider standard cardiogenic shock follow-up care first, or is participating in this trial something worth discussing now given where I am in my treatment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
1-year all-cause mortality and unplanned formal readmission after randomization (excluding emergency department visits)
Timeframe: From enrollment to the end of management up to 12 months
2
1-year all-cause mortality and unplanned formal readmission after randomization (excluding emergency department visits)
Timeframe: from enrollment to the end of treatment at 12 months