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

Not Applicable

Recruiting

• Conditions: Shock; Shock, Cardiogenic

• Registration Number: NCT07085221
• Lead Sponsor: Renmin Hospital of Wuhan University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-11-19
• Study First Submitted: 2025-07-14
• Study First Submitted QC: 2025-07-24
• Last Update Submitted: 2025-07-24
• Study First Posted: 2025-07-25
• Last Update Posted: 2025-07-25
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 472

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
1-year all-cause mortality and unplanned formal readmission after randomization (excluding emergency department visits)	From enrollment to the end of management up to 12 months

Secondary Outcome Measures

Name	Time	Method
all-cause mortality	From enrollment to the end of management up to 12 months
Rehospitalization for HF	From enrollment to the end of management up to 12 months
Recurrent MI	From enrollment to the end of management up to 12 months
Ischemia-driven repeat revascularization	From enrollment to the end of management up to 12 months
Stroke	From enrollment to the end of management up to 12 months
Bleeding Academic Research Consortium 3-5 grade	From enrollment to the end of management up to 12 months	BARC Bleeding Classification; • Type 0; No evidence of bleeding.; • Type 1; Mild bleeding requiring no medical intervention (e.g., patient self-discontinues medication without seeking medical attention).; • Type 2; Overt bleeding necessitating medical intervention (e.g., medication adjustment, hospitalization, or evaluation) but not meeting criteria for higher grades.; Examples: Subcutaneous bruising, epistaxis, or minor gastrointestinal bleeding.; * Type 3; * 3a: Hemoglobin drop of 3-5 g/dL or requiring transfusion; * 3b: Hemoglobin drop ≥5 g/dL, cardiac tamponade, need for surgical hemostasis, or vasoactive drugs; * 3c: Intracranial hemorrhage or intraocular bleeding causing visual impairment.; * Type 4; CABG-related bleeding (e.g., postoperative reoperation or massive transfusion).; * Type 5; * 5a: Clinically suspected fatal bleeding
Unplanned formal rehospitalization	From enrollment to the end of management up to 12 months
Types of GDMT medications	From enrollment to the end of management up to 12 months
GDMT target dose achievement rate	From enrollment to the end of management up to 12 months

Trial Locations

Locations (1)

Renmin Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China