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NCT06947148 | NOT YET RECRUITING | Heart Failure

The Impact of Comprehensive Post Hospital Management Based on DHI on Cardiac Function in Patients With HF
Sponsor:

Harbin Medical University

Information provided by (Responsible Party):

Y u BO

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.

Condition or disease

Heart Failure

Intervention/treatment

Comprehensive post hospital management based on digital health intervention(DHI)

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 300 participants
Masking : NONE
Primary Purpose : OTHER
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
Actual Study Start Date : 2025-05-06
Estimated Primary Completion Date : 2026-09-30
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
The Impact of Comprehensive Post Hospital Management Based on DHI on Cardiac Function in Patients With HF

Location Details

NCT06947148

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How to Participate

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Locations

Not yet recruiting

China, Heilongjiang

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China, 150000