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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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

  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)

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 groups in NCT05885425
Study groupRoleWhat they receive
100 patients with stabile chronic heart failure with remote controlGroup 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 controlGroup 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.

  1. Hospitalization for cardiac reasons

    Measured: 6 months

  2. Visit to the emergency room (urgent)

    Measured: 6 months

Secondary outcomes (4)
  1. Unplanned visit to cardiology / internist

    Measured: 6 months

  2. Calling Quick Medical Assistance home

    Measured: 6 months

  3. Fundamental change of treatment (new type of drug, change of drug group, increased dose)

    Measured: 6 months

  4. 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.

  1. First posted2 Jun 2023
  2. Study start1 Sep 2023 (estimated)
  3. Primary completion1 May 2024 (estimated)
  4. Study completion1 Sep 2024 (estimated)

Resources

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)
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.

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.

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