Ignite Creation Date:
2024-07-17 @ 11:02 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06478732
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-17
Brief Title:
HeartMed-HF Digital Therapeutics Improves Exercise Capacity in CHF Patients After AMI
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
The First Affiliated Hospital with Nanjing Medical University
Study Overview
Official Title:
HeartMed-HF Digital Therapeutics Improves Exercise Capacity in Patients With Chronic Heart Failure After Acute Myocardial Infarction an International Multi-center Randomized Controlled Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Chronic heart failure HF is a severe manifestation and terminal stage of various cardiovascular diseases with high incidence and mortality rates Myocardial infarction MI is currently one of the most common and significant causes of HF globally The occurrence of HF after MI significantly increases the mortality risk for patients Actively controlling risk factors and strengthening outpatient management of HF patients post-MI are crucial for alleviating clinical symptoms and enhancing exercise capacity Recently digital health interventions DHI have shown promising potential in managing cardiovascular disease patients However the application in patients with HF post-MI has not been well-reported Therefore this study independently and innovatively designed the HeartMed-HF digital therapeutics to demonstrate its effectiveness and safety in patients with HF after MI
Detailed Description:
Acute myocardial infarction AMI is caused by acute occlusion of the coronary artery and interruption of blood flow which leads to myocardium necrosis in the blood supply area of the culprit vessel AMI can lead to the loss of cardiomyocytes which in turn causes ventricular enlargement myocardial hypertrophy eventually leading to the decline of cardiac function In severe casesAMI may even result in acute or chronic heart failure HF Patients with HF after MI have significantly decreased quality of life high mortality and poor clinical prognosis Studies have shown that the incidence of HF in patients with ST-segment elevation myocardial infarction STEMI is about 218 and the 30-day mortality rate of patients with HF after MI is up to 25 The occurrence of HF after MI is associated with various factors Advanced age hypertension diabetes renal insufficiency rapid heart rate atrial fibrillation AF low left ventricular ejection fraction LVEF stroke are all risk factors Actively controlling these factors is crucial However due to the lack of medical knowledge poor self-mobility among HF patients outpatient management faces severe challenges Therefore strengthening outpatient management for patients with HF after MI is of great significance in alleviating clinical symptoms and improving patients exercise capacity
Recently the digital health intervention DHI industry composed of internet artificial intelligence AI mobile terminals and wearable devices has developed rapidly worldwide which plays an important role in health care DHI has shown promising prospects in the management of cardiovascular diseases It can be used for AF screening blood pressure management and reducing mortality in HF patients among other applications However the use in patients with HF after MI lacks large-scale evidence-based medical support
Therefore this study has independently designed the HeartMed-HF digital heart failure clinical management system for patients with HF after MI The system monitors patients weight heart rate blood pressure fluid intake and output and other HF evaluation indicators at home using wearable devices Combining data from patients medical histories laboratory test results and surgical records the system uses AI algorithms to generate personalized outpatient HF management plans achieving precise home-based clinical management for patients The core management components include health education symptom management continuous monitoring risk warning medication management and cardiac exercise rehabilitation Additionally the study will form a comprehensive clinical management team consisting of physician assistants rehabilitation trainers nutritionists psychologists and health managers Through an internet platform and mobile terminals the system closely connects patients and doctors extending inpatient treatment to the home and realizing a closed-loop clinical management model that integrates real-time monitoring early warning and timely intervention
Recently the digital health intervention DHI industry composed of internet artificial intelligence AI mobile terminals and wearable devices has developed rapidly worldwide which plays an important role in health care DHI has shown promising prospects in the management of cardiovascular diseases It can be used for AF screening blood pressure management and reducing mortality in HF patients among other applications However the use in patients with HF after MI lacks large-scale evidence-based medical support
Therefore this study has independently designed the HeartMed-HF digital heart failure clinical management system for patients with HF after MI The system monitors patients weight heart rate blood pressure fluid intake and output and other HF evaluation indicators at home using wearable devices Combining data from patients medical histories laboratory test results and surgical records the system uses AI algorithms to generate personalized outpatient HF management plans achieving precise home-based clinical management for patients The core management components include health education symptom management continuous monitoring risk warning medication management and cardiac exercise rehabilitation Additionally the study will form a comprehensive clinical management team consisting of physician assistants rehabilitation trainers nutritionists psychologists and health managers Through an internet platform and mobile terminals the system closely connects patients and doctors extending inpatient treatment to the home and realizing a closed-loop clinical management model that integrates real-time monitoring early warning and timely intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None