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Search / Trial NCT05651698

Personal Decision Support System for Heart Failure Management

Launched by UNIVERSITY GHENT · Dec 6, 2022

Trial Information

Current as of January 16, 2025

Completed

Keywords

Heart Failure Heart Failure Patients' Disease Management Health Related Quality Of Life M Health

ClinConnect Summary

Background:

1-2% of people in the developed world suffer from heart failure (HF), which costs the society around 100 billion USD per year. Although the improvements in treatment have lately decreased the number of hospitalizations and deaths due to HF, the burden still remains high with around half of the HF patients being expected to die within five years and HF being the most frequent cause of hospitalization in people aged over 65.

Since there is no cure available at present, a better management of HF is crucial. A proper disease management may not only relieve symptoms, prevent hospit...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Willing and able to make use of a smartphone and to give informed consent for participation to the study
  • Ischemic or non- ischemic heart failure disease
  • Functional New York Heart Association (NYHA) class 2-3
  • Reduced left ventricular ejection fraction ≤40%
  • Ambulatory HF patients in stable condition: at least one hospitalization due to their HF once, but no hospitalization during the month before start of the trial or no planned surgery
  • Good cognitive function, if cognitive impairment is suspected the patient will be evaluated by using the Mini Mental State Examination (MMSE)
  • Sufficient knowledge of the native language (Dutch in Belgium, Italian in Italy)
  • Exclusion Criteria:
  • Heart failure patients who fulfill the above mentioned criteria, but suffer from a concomitant end - stage chronic kidney disease necessitating haemodialysis
  • Heart failure patients who fulfill the above mentioned criteria, but are already participating in a disease management program, influencing the HeartMan intervention

Trial Officials

Paolo Emilio Puddu, Prof.

Principal Investigator

University of Roma La Sapienza

About University Ghent

University Ghent is a prestigious Belgian research institution renowned for its commitment to advancing medical science and improving patient care through innovative clinical trials. With a multidisciplinary approach, the university fosters collaboration among leading experts in various fields, ensuring rigorous study design and ethical standards. University Ghent is dedicated to exploring new therapeutic modalities and enhancing healthcare outcomes, making significant contributions to both local and global health landscapes. Its state-of-the-art facilities and emphasis on research excellence position it as a pivotal sponsor in the realm of clinical research.

Locations

Ghent, , Belgium

Rome, , Italy

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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