NCT05268978

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 7, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

November 11, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

January 29, 2024

Status Verified

January 1, 2024

Enrollment Period

6 months

First QC Date

January 31, 2022

Last Update Submit

January 26, 2024

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (12)

  • 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.

    3 month

  • 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.

    3 month

  • 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.

    3 month

  • 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.

    3 month

  • 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.

    3 month

  • 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.

    3 month

  • 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.

    3 month

  • 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

    3 month

  • 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

    3 month

  • 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

    3 month

  • 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

    3 month

  • 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.

    3 month

Interventions

MedimonitorDEVICE

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.

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine I - Cardiology, University Hospital Olomouc

Olomouc, 77900, Czechia

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 31, 2022

First Posted

March 7, 2022

Study Start

November 11, 2022

Primary Completion

April 26, 2023

Study Completion

May 1, 2023

Last Updated

January 29, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)