Advanced Telemonitoring of Patients With Heart Failure in Home Environment

Heart Failure Clinical Trial

Official title:

SHAPES Advanced Telemonitoring of Patients With Heart Failure in Home Environment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05268978
• Other study ID #: SHAPES UC-PT3-001c
• Status: Completed
• Start date: November 11, 2022
• Est. completion date: May 1, 2023

Study information

• Verified date: January 2024
• Source: University Hospital Olomouc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 1, 2023
• Est. primary completion date: April 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Medimonitor
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.

Locations

Country	Name	City	State
Czechia	Department of Internal Medicine I - Cardiology, University Hospital Olomouc	Olomouc

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Olomouc

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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