NCT07085221Toboroz
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. jún. 17.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 472 (tervezett)
- Első benyújtás
- 2025. júl. 14.
- Kezdés
- 2025. júl. 26.
- Elsődleges befejezés
- 2027. dec. 31.
- Fő szponzor
- Renmin Hospital of Wuhan University
- NCT-szám
- NCT07085221
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 472
- 2025. júl. 26. és az elsődleges befejezés (2027. dec. 31.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- The reasons for discharge were treatment withdrawal and transfer to another hospital for continued therapy
- Previous or current hospital admission due to cardiac arrest
Más betegség
- 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;
Laborértékek
- Left ventricular ejection fraction < 30%
Egyéb
- 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.
Kiket keres a vizsgálat
- 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)
- 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.
- 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.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Renmin Hospital of Wuhan University | Wuhan | Kína | Toboroz |
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