Clinical trial NCT05268978: Advanced Telemonitoring of Patients With Heart Failure in Home Environment
Official title: SHAPES Advanced Telemonitoring of Patients With Heart Failure in Home Environment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: University Hospital Olomouc
Sponsor class: OTHER
First posted: 2022-03-07
Enrollment: 25
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed heart failure with reduced ejection fraction due to non-ischemic cardiomyopathy.

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.


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

Primary outcomes:
measure: Evaluation of the effect of step telemonitoring during uptitration of heart failure medication.
timeFrame: 3 month
measure: Evaluation of the effect of ECG telemonitoring during uptitration of heart failure medication.
timeFrame: 3 month
measure: Evaluation of the effect of blood pressure telemonitoring during uptitration of heart failure medication.
timeFrame: 3 month
measure: Evaluation of the effect of body weight telemonitoring during uptitration of heart failure medication.
timeFrame: 3 month
measure: Evaluation of the effect of body water telemonitoring during uptitration of heart failure medication.
timeFrame: 3 month
measure: Evaluation of the effect of blood oxygen saturation telemonitoring during uptitration of heart failure medication.
timeFrame: 3 month
measure: Evaluation of changes of NTproBNP levels at the beginning vs. at the end of the study.
timeFrame: 3 month
measure: Evaluation of changes in LVEF echocardiographic parameter at the beginning vs. at the end of study.
timeFrame: 3 month
measure: Evaluation of changes in LVEDD echocardiographic parameter at the beginning vs. at the end of study.
timeFrame: 3 month
measure: Evaluation of changes in LVESD echocardiographic parameter at the beginning vs. at the end of study.
timeFrame: 3 month
measure: Evaluation of changes in LAVi echocardiographic parameter at the beginning vs. at the end of study.
timeFrame: 3 month
measure: Evaluation of changes in diastolic dysfunction by echocardiography at the beginning vs. at the end of study.
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Olomouc
country: Czechia
facility: Department of Internal Medicine I - Cardiology, University Hospital Olomouc
Study officials:
References: