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CompletedNCT05268978Updated Jan 29, 2024

Advanced Telemonitoring of Patients With Heart Failure in Home Environment

An observational study in Heart Failure, sponsored by University Hospital Olomouc. Completed at 1 site in Czechia. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-01-29.

Sponsored by University Hospital Olomouc · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
25
Ages
60 Years and older
Sex
All
01

Study summary

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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Conditions studied

  • Heart Failure

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03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 25 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

University Hospital Olomouc is the lead sponsor of 40 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with newly diagnosed heart failure with reduced ejection fraction due to non-ischemic cardiomyopathy.

Eligibility criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
25 participants (actual)
Patient registry
No

Interventions

  • DeviceMedimonitor

    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.

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What researchers measure

Primary outcomes

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

    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.

    Time frame: 3 month

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

    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.

    Time frame: 3 month

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

    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.

    Time frame: 3 month

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

    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.

    Time frame: 3 month

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

    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.

    Time frame: 3 month

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

    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.

    Time frame: 3 month

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

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

    Time frame: 3 month

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

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

    Time frame: 3 month

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

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

    Time frame: 3 month

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

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

    Time frame: 3 month

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

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

    Time frame: 3 month

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

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

    Time frame: 3 month

07

Study locations

1 site
  • Department of Internal Medicine I - Cardiology, University Hospital Olomouc
    Olomouc, 77900, Czechia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05268978
Lead sponsor
University Hospital Olomouc
Responsible party
Ladislav Stanke (Principal Investigator, University Hospital Olomouc) — Principal investigator
First posted
Mar 7, 2022
Start date
Nov 11, 2022
Primary completion
Apr 26, 2023
Completion
May 1, 2023
Last update
Jan 29, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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