Can a smartphone app and smart blood pressure cuff save heart shock patients?
NCT ID NCT07085221
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a digital platform that monitors blood pressure and symptoms at home can improve outcomes for people with early cardiogenic shock, a serious heart condition. About 472 patients will be split into two groups: one gets standard discharge care, the other gets the digital system plus health coaching. The goal is to see if the digital approach reduces deaths and unplanned hospital visits over one year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Digital out-of-hospital management platform (HeartMed-HF) with chip-implanted blood pressure monitor
- What this could lead to
- If it works, this could provide a practical way to monitor and support heart shock patients at home, potentially lowering deaths and hospital returns.
- What could go wrong
- This is an early-stage trial with 472 participants, so results may not apply to all patients. The digital system might not prevent serious complications, and technical issues could limit its use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 472 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Renmin Hospital of Wuhan University
RECRUITINGWuhan, Hubei, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a blood enzyme reveal who will survive deadly shock?
- Could less food help critically ill patients recover faster?
- Ultrasound could reveal when ICU tube feeding fails
- A new device aims to track the heart's pumping power in the ICU — without invasive tubes
- New pressure test may help doctors give right fluids in shock
- Non-invasive heart monitor tested against standard method in shock patients