Management of Telemedicine Monitoring of Patients With Chronic Heart Failure
TELEHEART-Management of Telemedicine Monitoring of Patients With Chronic Heart Failure
1 other identifier
observational
200
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2023
Shorter than P25 for all trials
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
May 22, 2023
CompletedFirst Posted
Study publicly available on registry
June 2, 2023
CompletedStudy Start
First participant enrolled
September 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedJune 2, 2023
May 1, 2023
8 months
May 22, 2023
May 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Hospitalization for cardiac reasons
6 months
Visit to the emergency room (urgent)
6 months
Secondary Outcomes (4)
Unplanned visit to cardiology / internist
6 months
Calling Quick Medical Assistance home
6 months
Fundamental change of treatment (new type of drug, change of drug group, increased dose)
6 months
Fundamental changes in the quality of life according to questionnaires
6 months
Study Arms (2)
100 patients with stabile chronic heart failure with remote control
Group 1 is the intervention group, their health status will be monitored telemetrically for a half year by several electronic devices (for measurement of hearth frequency, blood pressure, blood saturation and periodically ECG recordings). Data will be periodically transmitted to the doctor in the ambulance. If measured data will indicated any worsening of heath (decompensation of circulation), physician will adjust the treatment remotely.
Non-intervention group: 100 patients with stabile chronic heart failure without remote control
Group 2 with patients with chronic heart failure in the non-intervention group, they will not be contacted by own physician for half a year - the planned periodic control will be scheduled after half a year.
Interventions
On the basis of telemedicine data, the doctor will remotely correct medical treatment by adjusting the dose or supplementing or by omitting the medicine in order to improve the state of health, or to alleviate the symptoms of the disease monitored by telemedicine
Based on telemedicine data, the doctor can consider periodic education of the patient with the innervated group in order to improve lifestyle
Eligibility Criteria
Patients with congestive heart failure with ejection fraction less than 45%
You may qualify if:
- 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
You may not qualify if:
- malignant diseases
- planned cardiac surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eva Goncalvesova
National Institute of Vascular and Heart Diseases Bratislava
- STUDY CHAIR
Fedor Lehocki
Slovak University of Technology in Bratislava
- STUDY DIRECTOR
Jozef Benacka
Trnava University in Trnava
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2023
First Posted
June 2, 2023
Study Start
September 1, 2023
Primary Completion
May 1, 2024
Study Completion
September 1, 2024
Last Updated
June 2, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share
No.