Clinical trial NCT06947148: The Impact of Comprehensive Post Hospital Management Based on DHI on Cardiac Function in Patients With HF
Official title: The Impact of Comprehensive Post Hospital Management Based on Digital Health Intervention on Cardiac Function in Patients With Heart Failure: a Prospective, Multicenter, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Digital Health Intervention
Remote Dielectric Sensing
ReDS™
Comprehensive Health Care
6 Min Walk Test
Randomized Controlled Trial
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 300
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Due to the complex nature of HF patients' conditions, long-term treatment and management are required, especially post hospital management, which is of great significance for improving patients' cardiac function and quality of life. With the increasing popularity of smartphones and the continuous development of medical technology, digital health intervention (DHI) has emerged as a new medical model in the treatment of diseases.

This study will establish a comprehensive post hospital management model of HF based on DHI, including cognitive behavioral therapy, digital self-monitoring and remote dielectric sensing (ReDS™) technology, etc., comprehensively strengthen the post hospital intervention and management of HF. Objective to explore the effect of comprehensive post hospital management based on DHI on cardiac function of patients with HF 6 months after discharge.


Eligibility criteria: Inclusion Criteria:

1. Patients hospitalized for HF, NYHA classification II-IV upon admission
2. The patient's residence is within the urban area of each center, and ReDS™ technology can be performed at home or at the outpatient clinic
3. No difficulty using smartphones, with basic Chinese reading and writing skills
4. Accept the terms and conditions of the study and obtain informed consent from the subjects/their families

Exclusion Criteria:

1. Age\<21 years old
2. Patients with height\<155 cm or\>190 cm, BMI\<22 kg/m2 or\>36 kg/m2, chest circumference\<80 cm or\>115 cm, and flail chest or rib fractures
3. History of pulmonary embolism
4. chronic renal failure（Scr \> 443umol/L）
5. History of heart transplantation or pacemaker implantation
6. Severe pulmonary hypertension
7. Suffering from end-stage chronic obstructive pulmonary disease, requiring home oxygen therapy
8. Massive pleural effusion
9. The subject is unable to complete the 6-minute walking test
10. Expected lifespan\<6 months
11. Researchers believe that participants are not suitable to participate in this trial (such as pregnancy, severe visual or hearing impairment, etc.)
12. Individuals who are unable to understand and/or comply with this research procedure (such as those who are addicted to alcohol, substance abuse, or have mental illnesses)
13. Currently participating in clinical trials of other devices or drugs
14. Researchers involved in the design and execution of this study

Primary outcomes:
measure: 6-minute walk test
timeFrame: The 6th month after discharge
Secondary outcomes:
measure: Quality of life index (QLI) rating
timeFrame: The 1st ,3rd and 6th months after discharge
measure: Kansas city cardiomyopathy questionnaire (KCCQ-23) rating
timeFrame: The 1st ,3rd and 6th months after discharge
measure: NYHA classification
timeFrame: The 1st ,3rd and 6th months after discharge
measure: Left ventricular ejection fraction (LVEF)
timeFrame: The 6th month after discharge
measure: Number of readmissions for heart failure
timeFrame: Within 6 months after discharge
measure: All-cause mortality
timeFrame: Within 6 months after discharge
measure: Cardiac death
timeFrame: Within 6 months after discharge
measure: Composite endpoint of all-cause death or readmission due to heart failure
timeFrame: Within 6 months after discharge
measure: Time to first hospitalization for heart failure from baseline
timeFrame: Within 6 months after discharge
Other outcomes:
Locations:
city: Harbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
state: Heilongjiang
Study officials:
References: