Congestive Heart Failure ChronicNCT05885425
Management of Telemedicine Monitoring of Patients With Chronic Heart Failure
An observational study of Congestive Heart Failure Chronic, run by Trnava University in Trnava.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Congestive Heart Failure Chronic
- What is being tested?
- Telemedicine correction of medical treatment and Education for proper lifestyle
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with congestive heart failure with ejection fraction less than 45%
Who may be able to join
- 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
Who cannot join
- malignant diseases
- planned cardiac surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: TELEHEART-Management of Telemedicine Monitoring of Patients With Chronic Heart Failure
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.
Read the 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
- st morning in bed after waking up (stick electrodes for whole day)
- nd. after breakfast (or an hour after getting out of bed)
- 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)
- Conditions
- Congestive Heart Failure Chronic
- Being tested
- Telemedicine correction of medical treatment, Education for proper lifestyle
- Keywords
- Congestive Heart Failure, Telemedicine
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine correction of medical treatmentBehavioural
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
Education for proper lifestyleBehavioural
Based on telemedicine data, the doctor can consider periodic education of the patient with the innervated group in order to improve lifestyle
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Telemedicine correction of medical treatment; Behavioral: Education for proper lifestyle | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization for cardiac reasons
Measured: 6 months
Visit to the emergency room (urgent)
Measured: 6 months
Secondary outcomes (4)
Unplanned visit to cardiology / internist
Measured: 6 months
Calling Quick Medical Assistance home
Measured: 6 months
Fundamental change of treatment (new type of drug, change of drug group, increased dose)
Measured: 6 months
Fundamental changes in the quality of life according to questionnaires
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart Failure ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trnava University in Trnava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eva Goncalvesova, Principal investigator, National Institute of Vascular and Heart Diseases BratislavaFedor Lehocki, Study chair, Slovak University of Technology in BratislavaJozef Benacka, Study director, Trnava University in Trnava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885425
- Sponsor's protocol ID
- OPII-VA/DP/2021/9.3-01
- Status last verified
- May 2023
- First submitted
- 22 May 2023
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TELEHEART-Management of Telemedicine Monitoring of Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT05885425
- Acronym / sponsor ID
- OPII-VA/DP/2021/9.3-01
- Conditions
- Congestive Heart Failure Chronic
- Keywords
- Congestive Heart Failure, Telemedicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Trnava University in TrnavaUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- st morning in bed after waking up (stick electrodes for whole day)
- nd. after breakfast (or an hour after getting out of bed)
- 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)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 100 patients with stabile chronic heart failure with remote control | – | Behavioral: Telemedicine correction of medical treatment, Behavioral: Education for proper lifestyleGroup 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. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with congestive heart failure with ejection fraction less than 45%
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- malignant diseases
- planned cardiac surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedicine correction of medical treatmentOn 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 | Behavioural | 100 patients with stabile chronic heart failure with remote control |
| Education for proper lifestyleBased on telemedicine data, the doctor can consider periodic education of the patient with the innervated group in order to improve lifestyle | Behavioural | 100 patients with stabile chronic heart failure with remote control |
Primary outcome
Hospitalization for cardiac reasons
Time frame: 6 months
Visit to the emergency room (urgent)
Time frame: 6 months
4 secondary outcomes
Unplanned visit to cardiology / internist
Time frame: 6 months
Calling Quick Medical Assistance home
Time frame: 6 months
Fundamental change of treatment (new type of drug, change of drug group, increased dose)
Time frame: 6 months
Fundamental changes in the quality of life according to questionnaires
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Individual participant dataSharing planned: No. No.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Goncalvesova principal investigator
National Institute of Vascular and Heart Diseases Bratislava
Fedor Lehocki study chair
Slovak University of Technology in Bratislava
Jozef Benacka study director
Trnava University in Trnava
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure Chronic, run by Trnava University in Trnava.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvia Putekova (+421908835994, silvia.putekova@truni.sk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization for cardiac reasons (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.