Clinical trial NCT05885425: Management of Telemedicine Monitoring of Patients With Chronic Heart Failure
Official title: TELEHEART-Management of Telemedicine Monitoring of Patients With Chronic Heart Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congestive Heart Failure Chronic
Keywords: Congestive Heart Failure, Telemedicine
Lead sponsor: Trnava University in Trnava
Sponsor class: OTHER
First posted: 2023-06-02
Enrollment: 200
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with congestive heart failure with ejection fraction less than 45%

Brief summary: Objective: to evaluate the possibilities and effect of telemedicine monitoring and management of patients with CHF (compared to patients with CHF without intensive telemedicine monitoring) on quality of life, prognosis and the presence of complications and hospitalisations.

Patients with a stable form of congestive heart failure will be gradually included in the study. Half of them will be defined by random selection to intervention group. Parameters, that can be measured at home will be periodically telemedical monitored. In according with at home monitored data, the own physician will be able to intervene with change of medical treatment in the case of non-physiological deviations in order to improve the health status as well as the prognosis of the patient with CHF.

Detailed description: Inclusion criteria:

* Age between 45 and 75
* Congestive heart failure (CHF), NYHA II - VI (any genesis)
* EF less then 45%, any rhythm (sinus or atrial fibrillation)
* More as two months stable condition
* Complete treatment according to recommendations (guidelines): ACEI (alternatively ARNI / sartan) + diuretics + betablockers (as alternative digitalis)
* Without hospitalization with CHF decompensation more as two months before enrolment
* No severe liver disease and hemodialysis treatment
* No planned any cardio-surgery intervention in the next six months
* No a serious valvular defects

Input and output surveys (measurements, tests) upon enrollment and after half a year ECHOCG (mandatory parameters: EF, LVDd, IVCT, E/A, LA diameter, LA area planimetrically) Blod pressure, frequency, ECG (PQ, QT, description: blockages, STT segment changes) Six minutes walking test Serum analysis: NTproBNP, CRP, natrium, potassium, urea, creatinine

Questionnaires:

* Kansas Quality of Life Questionnaire (KCCQ)
* Questionnaire SF 36 (perception of illness)
* Beck's Depression Inventory (21 questions) - depression questionnaire
* Beck's Anxiety Inventory (21 questions) - anxiety questionnaire (standardized questionnaires translated into Slovak)

Telemedicine monitoring: the patient will have at home devices for:

ECG recording Blood pressure and pulse sensor O2 saturation sensor Personal weight machine

Data will be transferred via smartphone software (supplied by the organizer) once a week too physician:

ECG recording on the patient's instructions

1. st morning in bed after waking up (stick electrodes for whole day)
2. nd. after breakfast (or an hour after getting out of bed)
3. th. around 12 o'clock (time of lunch)

In the same day morning, weight and other measurements (O2, blood pressure, pulse)

As part of the data transfer, the information for physician:

possibility to send a comment "how I feel" the number of urinations per night Data is entered into a standard table in the doctor's software (supplied by the organizer) Based on the obtained data, the doctor can correct the treatment at any time by telephone

Physician will control the transferred data from patient at least once every week.

The organizer will deliver Personal weight machine (new uniform) Questionnaires (in printed form) Informed consents devices for monitoring of physiological functions (ECG, O2, pulse, blood pressure) Application for the patient's smartphone (for simple data transfer) Software recording data from the patient to the PC at the physician's office Compensation 100,- € (motivation for each participant - intervened or non-intervened) similar compensation is assumed at the end of follow-up (for each patient) The ECG sensor will remain available to the physicians Included doctors will be co-authors of publications in foreign journals.

Monitored events ("end points"):

hospitalization for cardiac causes visit to the emergency room (urgent) calling Quick Medical Assistance at home unplanned visit by cardiologist / internist fundamental change of treatment (new type of drug, change of drug group, increased dose) fundamental changes (deterioration) in the perception of the disease (SF 36) major changes in quality of life (Kansas Questionnaire) fundamental changes in the perception of depression (Beck's Depression Inventory) fundamental changes in the perception of anxiety (Beck's Anxiety Inventory) Death

Evaluation in addition to endpoints:

long-term trend of resting frequency long-term trend of increased frequency after morning exercise and during the day long-term blood pressure and saturation trends number of telephone contacts by physicians with the patient in the case of using a "smart watch", also trends in sleep parameters (frequency, apnea, sleep quality, caloric expenditure / day)

Eligibility criteria: Inclusion Criteria:

* Congestive heart failure (CHF), NYHA II - VI (any genesis)
* EF less then 45%, any rhythm (sinus or atrial fibrillation)
* More as two months stable condition
* Complete treatment according to recommendations (guidelines): ACEI (alternatively ARNI / sartan) + diuretics + betablockers (as alternative digitalis)
* Without hospitalization with CHF decompensation more as two months before enrolment

Exclusion Criteria:

* malignant diseases
* planned cardiac surgery

Primary outcomes:
measure: Hospitalization for cardiac reasons
timeFrame: 6 months
measure: Visit to the emergency room (urgent)
timeFrame: 6 months
Secondary outcomes:
measure: Unplanned visit to cardiology / internist
timeFrame: 6 months
measure: Calling Quick Medical Assistance home
timeFrame: 6 months
measure: Fundamental change of treatment (new type of drug, change of drug group, increased dose)
timeFrame: 6 months
measure: Fundamental changes in the quality of life according to questionnaires
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: National Institute of Vascular and Heart Diseases Bratislava
name: Eva Goncalvesova
role: PRINCIPAL_INVESTIGATOR
affiliation: Slovak University of Technology in Bratislava
name: Fedor Lehocki
role: STUDY_CHAIR
affiliation: Trnava University in Trnava
name: Jozef Benacka
role: STUDY_DIRECTOR
References: