Digital Out-of-hospital Management on Clinical Outcomes in Patients With Early Cardiogenic Shock

Официальное название

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

Обзор

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.

Вмешательства

• Комбинированный продукт hospital external management
  (I) Symptom management: After enrollment, health managers regularly promoted health education to enhance patients' awareness of the disease and adherence to post-discharge management. Simultaneously, patients were managed via a digital platform, with each patient being provided with a chip-implanted sphygmomanometer to monitor their blood pressure and pulse in real time. If patients develop symptoms, they can report them in real-time and generate alerts to health managers. Through internal clini

Первичные конечные точки

• 1-year all-cause mortality and unplanned formal readmission after randomization (excluding emergency department visits) [Срок оценки: From enrollment to the end of management up to 12 months]
• 1-year all-cause mortality and unplanned formal readmission after randomization (excluding emergency department visits) [Срок оценки: from enrollment to the end of treatment at 12 months]

Вторичные конечные точки (9)

• all-cause mortality [Срок оценки: From enrollment to the end of management up to 12 months]
• Rehospitalization for HF [Срок оценки: From enrollment to the end of management up to 12 months]
• Recurrent MI [Срок оценки: From enrollment to the end of management up to 12 months]
• Ischemia-driven repeat revascularization [Срок оценки: From enrollment to the end of management up to 12 months]
• Stroke [Срок оценки: From enrollment to the end of management up to 12 months]
• Bleeding Academic Research Consortium 3-5 grade [Срок оценки: From enrollment to the end of management up to 12 months]
• Unplanned formal rehospitalization [Срок оценки: From enrollment to the end of management up to 12 months]
• Types of GDMT medications [Срок оценки: From enrollment to the end of management up to 12 months]
• GDMT target dose achievement rate [Срок оценки: From enrollment to the end of management up to 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Unable to use a smartphone for out-of-hospital management despite training
• The reasons for discharge were treatment withdrawal and transfer to another hospital for continued therapy
• Previous or current hospital admission due to cardiac arrest
• Refractory cardiogenic shock
• Refractory Heart Failure (ACC/AHA guidelines Stage D heart Failure)
• Left ventricular ejection fraction < 30%
• (Estimated) glomerular filtration rate < 25 ml/min or on dialysis
• 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
• Pregnant or lactating women
• Combined with malignant tumors and other serious diseases, the expected life span is less than 1 year
• Neuropsychiatric disorders, unable to cooperate with management;
• Participation in other clinical trials within the past year;
• Other circumstances considered to be inappropriate for this study by the investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Китай · 1 центр

• Renmin Hospital of Wuhan University — Ухань

Идентификаторы

NCT: NCT07085221 · WDRY2024-K234

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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