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NCT Number: NCT06947148

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients hospitalized for HF, NYHA classification II-IV upon admission
  • 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
  • No difficulty using smartphones, with basic Chinese reading and writing skills
  • Accept the terms and conditions of the study and obtain informed consent from the subjects/their families

Exclusion criteria

  • Age<21 years old
  • 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
  • History of pulmonary embolism
  • chronic renal failure（Scr > 443umol/L）
  • History of heart transplantation or pacemaker implantation
  • Severe pulmonary hypertension
  • Suffering from end-stage chronic obstructive pulmonary disease, requiring home oxygen therapy
  • Massive pleural effusion
  • The subject is unable to complete the 6-minute walking test
  • Expected lifespan<6 months
  • Researchers believe that participants are not suitable to participate in this trial (such as pregnancy, severe visual or hearing impairment, etc.)
  • 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)
  • Currently participating in clinical trials of other devices or drugs
  • Researchers involved in the design and execution of this study

Treatment and study plan

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

Other

Based on the routine HF management of standard of care (SOC), the intervention group will carry out comprehensive post hospital management based on DHI, including cognitive behavioral therapy, digital self-monitoring and ReDS™ technology, etc.

Primary outcomes

  1. 6-minute walk test

    Time frame: The 6th month after discharge

    Improvement in 6-minute walk test after discharge for 6 months

Secondary outcomes

  1. Quality of life index (QLI) rating

    Time frame: The 1st ,3rd and 6th months after discharge

  2. Kansas city cardiomyopathy questionnaire (KCCQ-23) rating

    Time frame: The 1st ,3rd and 6th months after discharge

  3. NYHA classification

    Time frame: The 1st ,3rd and 6th months after discharge

  4. Left ventricular ejection fraction (LVEF)

    Time frame: The 6th month after discharge

    Measured by echocardiography

  5. Number of readmissions for heart failure

    Time frame: Within 6 months after discharge

    Number of readmissions for hospitalized patients with heart failure due to worsening heart failure after discharge

  6. All-cause mortality

    Time frame: Within 6 months after discharge

  7. Cardiac death

    Time frame: Within 6 months after discharge

    Any death caused by heart disease (such as myocardial infarction, low output HF, fatal arrhythmia), death without witnesses, death from unknown causes, and all surgery related deaths, including those related to concurrent treatment, are classified as cardiac death

  8. Composite endpoint of all-cause death or readmission due to heart failure

    Time frame: Within 6 months after discharge

  9. Time to first hospitalization for heart failure from baseline

    Time frame: Within 6 months after discharge

Sponsors and collaborators

Lead sponsor

Harbin Medical University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 27, 2025
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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