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NCT Number: NCT05268978

Advanced Telemonitoring of Patients With Heart Failure in Home Environment

Heart failure is currently not only a major medical but also a socio-economic problem. Its prevalence is estimated at 1-2% of the population with an exponential increase in older age groups. A very important part of the treatment of heart failure is the gradual uptitration of therapy to the maximum tolerated doses. Properly conducted therapy titration requires more frequent patient contact. Thanks to the introduction of telemedicine techniques, the investigators can communicate more effectively with the patient, reach the target doses of heart failure medication faster and subsequently reduce the number of hospitalizations due to worsening of heart failure.

This study investigates effect of advanced telemonitoring of patients with heart failure in home environment.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Internal Medicine I - Cardiology, University Hospital Olomouc

Olomouc, 77900, Czechia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • LVEF ≤ 40%
  • exclusion of obstructive coronary artery disease
  • NTproBNP ≥ 125pg/ml
  • ≥ 60 years of age
  • Informed written and verbal consent
  • Able to participate in study activities

Exclusion criteria

  • LVEF ≥ 40%
  • Ischaemic ethiology of cardiomyopathy
  • NTproBNP ≤ 125pg/ml
  • Severe psychological disturbances
  • Absence of collaboration (informed consent)
  • BP ≤ 110mmHg without hypertensive medication

Treatment and study plan

Medimonitor

Device

A digital solution consisting of smartphone/tablet based application gathering data from medical and other devices provided to the patients. These devices are as follows: tablet, smartwatch, mobile ECG, blood pressure monitor, weight scales, pulse oximetry device.

Primary outcomes

  1. Evaluation of the effect of step telemonitoring during uptitration of heart failure medication.

    Time frame: 3 month

    Uptitration of therapy guided by data from the medical and other devices (tablet with smartwatch providing data from the pedometer, i.e. number of steps) provided to the patients with heart failure in home environment.

  2. Evaluation of the effect of ECG telemonitoring during uptitration of heart failure medication.

    Time frame: 3 month

    Uptitration of therapy guided by data from medical and other devices (tablet with mobile ECG) provided to the patients with heart failure in home environment.

  3. Evaluation of the effect of blood pressure telemonitoring during uptitration of heart failure medication.

    Time frame: 3 month

    Uptitration of therapy guided by data from medical and other devices (tablet and blood pressure monitor recording systolic and diastolic blood pressure) provided to the patients with heart failure in home environment.

  4. Evaluation of the effect of body weight telemonitoring during uptitration of heart failure medication.

    Time frame: 3 month

    Uptitration of therapy guided by data from medical and other devices (tablet and diagnostic weight scales for monitoring weight in kilograms) provided to the patients with heart failure in home environment.

  5. Evaluation of the effect of body water telemonitoring during uptitration of heart failure medication.

    Time frame: 3 month

    Uptitration of therapy guided by data from medical and other devices (tablet and diagnostic weight scales for monitoring body water percentage) provided to the patients with heart failure in home environment.

  6. Evaluation of the effect of blood oxygen saturation telemonitoring during uptitration of heart failure medication.

    Time frame: 3 month

    Uptitration of therapy guided by data from medical and other devices (tablet and pulse oximetry device to monitor blood oxygen saturation in percents) provided to the patients with heart failure in home environment.

  7. Evaluation of changes of NTproBNP levels at the beginning vs. at the end of the study.

    Time frame: 3 month

    Evaluation of changes of NTproBNPlevels as a marker of effective therapy of heart failure.

  8. Evaluation of changes in LVEF echocardiographic parameter at the beginning vs. at the end of study.

    Time frame: 3 month

    Assessment of the effect of heart failure therapy (left ventricular reverse remodelation) by evaluation of changes in LVEF echocardiographic parameter

  9. Evaluation of changes in LVEDD echocardiographic parameter at the beginning vs. at the end of study.

    Time frame: 3 month

    Assessment of the effect of heart failure therapy (left ventricular reverse remodelation) by evaluation of changes in LVEDD echocardiographic parameter

  10. Evaluation of changes in LVESD echocardiographic parameter at the beginning vs. at the end of study.

    Time frame: 3 month

    Assessment of the effect of heart failure therapy (left ventricular reverse remodelation) by evaluation of changes in LVESD echocardiographic parameter

  11. Evaluation of changes in LAVi echocardiographic parameter at the beginning vs. at the end of study.

    Time frame: 3 month

    Assessment of the effect of heart failure therapy (left ventricular reverse remodelation) by evaluation of changes in LAVi echocardiographic parameter

  12. Evaluation of changes in diastolic dysfunction by echocardiography at the beginning vs. at the end of study.

    Time frame: 3 month

    Assessment of the effect of heart failure therapy (left ventricular reverse remodelation) by evaluation of changes in diastolic dysfunction.

Sponsors and collaborators

Lead sponsor

University Hospital Olomouc

Other

Registry information

Official study title

SHAPES Advanced Telemonitoring of Patients With Heart Failure in Home Environment

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 7, 2022
Registry last updated
Jan 29, 2024

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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