Heart FailureNCT05268978
Advanced Telemonitoring of Patients With Heart Failure in Home Environment
An observational study of Heart Failure, run by University Hospital Olomouc at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Medimonitor
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 25 participants
- Where
- 1 siteCzechia
- Study dates
- 11 Nov 2022to 1 May 2023
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with newly diagnosed heart failure with reduced ejection fraction due to non-ischemic cardiomyopathy.
Who may be able to join
- LVEF ≤ 40%
Who cannot join
- NTproBNP ≥ 125pg/ml
- ≥ 60 years of age
- Informed written and verbal consent
- Able to participate in study activities
- LVEF ≥ 40%
- Ischaemic ethiology of cardiomyopathy
Show all 10Show fewer
- NTproBNP ≤ 125pg/ml
- Severe psychological disturbances
- Absence of collaboration (informed consent)
- BP ≤ 110mmHg without hypertensive medication
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Department of Internal Medicine I - Cardiology, University Hospital Olomouc
Olomouc, 77900
About this study
Official title: SHAPES Advanced Telemonitoring of Patients With Heart Failure in Home Environment
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.
- Conditions
- Heart Failure
- Being tested
- Medimonitor
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedimonitorDevice
A digital solution consisting of smartphone/tablet based application gathering data from medical and other devices provided to the patients. These devices are as follows: tablet, smartwatch, mobile ECG, blood pressure monitor, weight scales, pulse oximetry device.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the effect of step telemonitoring during uptitration of heart failure medication.
Uptitration of therapy guided by data from the medical and other devices (tablet with smartwatch providing data from the pedometer, i.e. number of steps) provided to the patients with heart failure in home environment.
Measured: 3 month
Evaluation of the effect of ECG telemonitoring during uptitration of heart failure medication.
Uptitration of therapy guided by data from medical and other devices (tablet with mobile ECG) provided to the patients with heart failure in home environment.
Measured: 3 month
Evaluation of the effect of blood pressure telemonitoring during uptitration of heart failure medication.
Uptitration of therapy guided by data from medical and other devices (tablet and blood pressure monitor recording systolic and diastolic blood pressure) provided to the patients with heart failure in home environment.
Measured: 3 month
Evaluation of the effect of body weight telemonitoring during uptitration of heart failure medication.
Uptitration of therapy guided by data from medical and other devices (tablet and diagnostic weight scales for monitoring weight in kilograms) provided to the patients with heart failure in home environment.
Measured: 3 month
Evaluation of the effect of body water telemonitoring during uptitration of heart failure medication.
Uptitration of therapy guided by data from medical and other devices (tablet and diagnostic weight scales for monitoring body water percentage) provided to the patients with heart failure in home environment.
Measured: 3 month
Evaluation of the effect of blood oxygen saturation telemonitoring during uptitration of heart failure medication.
Uptitration of therapy guided by data from medical and other devices (tablet and pulse oximetry device to monitor blood oxygen saturation in percents) provided to the patients with heart failure in home environment.
Measured: 3 month
Evaluation of changes of NTproBNP levels at the beginning vs. at the end of the study.
Evaluation of changes of NTproBNPlevels as a marker of effective therapy of heart failure.
Measured: 3 month
Evaluation of changes in LVEF echocardiographic parameter at the beginning vs. at the end of study.
Assessment of the effect of heart failure therapy (left ventricular reverse remodelation) by evaluation of changes in LVEF echocardiographic parameter
Measured: 3 month
Evaluation of changes in LVEDD echocardiographic parameter at the beginning vs. at the end of study.
Assessment of the effect of heart failure therapy (left ventricular reverse remodelation) by evaluation of changes in LVEDD echocardiographic parameter
Measured: 3 month
Evaluation of changes in LVESD echocardiographic parameter at the beginning vs. at the end of study.
Assessment of the effect of heart failure therapy (left ventricular reverse remodelation) by evaluation of changes in LVESD echocardiographic parameter
Measured: 3 month
Evaluation of changes in LAVi echocardiographic parameter at the beginning vs. at the end of study.
Assessment of the effect of heart failure therapy (left ventricular reverse remodelation) by evaluation of changes in LAVi echocardiographic parameter
Measured: 3 month
Evaluation of changes in diastolic dysfunction by echocardiography at the beginning vs. at the end of study.
Assessment of the effect of heart failure therapy (left ventricular reverse remodelation) by evaluation of changes in diastolic dysfunction.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start11 Nov 2022
- Primary completion26 Apr 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Olomouc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ladislav Stanke, University Hospital Olomouc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268978
- Sponsor's protocol ID
- SHAPES UC-PT3-001c
- Status last verified
- Jan 2024
- First submitted
- 31 Jan 2022
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SHAPES Advanced Telemonitoring of Patients With Heart Failure in Home Environment
- ClinicalTrials.gov ID
- NCT05268978
- Acronym / sponsor ID
- SHAPES UC-PT3-001c
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital OlomoucUniversity, hospital or other
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 26 Apr 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 7 Mar 2022 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly diagnosed heart failure with reduced ejection fraction due to non-ischemic cardiomyopathy.
Key inclusion criteria (1 listed)
- LVEF ≤ 40%
Key exclusion criteria (10 listed)
- NTproBNP ≥ 125pg/ml
- ≥ 60 years of age
- Informed written and verbal consent
- Able to participate in study activities
- LVEF ≥ 40%
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 |
|---|---|---|
| MedimonitorA digital solution consisting of smartphone/tablet based application gathering data from medical and other devices provided to the patients. These devices are as follows: tablet, smartwatch, mobile ECG, blood pressure monitor, weight scales, pulse oximetry device. | Device | – |
Primary outcome
Evaluation of the effect of step telemonitoring during uptitration of heart failure medication.
Time frame: 3 month
Uptitration of therapy guided by data from the medical and other devices (tablet with smartwatch providing data from the pedometer, i.e. number of steps) provided to the patients with heart failure in home environment.
Evaluation of the effect of ECG telemonitoring during uptitration of heart failure medication.
Time frame: 3 month
Uptitration of therapy guided by data from medical and other devices (tablet with mobile ECG) provided to the patients with heart failure in home environment.
Evaluation of the effect of blood pressure telemonitoring during uptitration of heart failure medication.
Time frame: 3 month
Uptitration of therapy guided by data from medical and other devices (tablet and blood pressure monitor recording systolic and diastolic blood pressure) provided to the patients with heart failure in home environment.
Evaluation of the effect of body weight telemonitoring during uptitration of heart failure medication.
Time frame: 3 month
Uptitration of therapy guided by data from medical and other devices (tablet and diagnostic weight scales for monitoring weight in kilograms) provided to the patients with heart failure in home environment.
Evaluation of the effect of body water telemonitoring during uptitration of heart failure medication.
Time frame: 3 month
Uptitration of therapy guided by data from medical and other devices (tablet and diagnostic weight scales for monitoring body water percentage) provided to the patients with heart failure in home environment.
Evaluation of the effect of blood oxygen saturation telemonitoring during uptitration of heart failure medication.
Time frame: 3 month
Uptitration of therapy guided by data from medical and other devices (tablet and pulse oximetry device to monitor blood oxygen saturation in percents) provided to the patients with heart failure in home environment.
Evaluation of changes of NTproBNP levels at the beginning vs. at the end of the study.
Time frame: 3 month
Evaluation of changes of NTproBNPlevels as a marker of effective therapy of heart failure.
Evaluation of changes in LVEF echocardiographic parameter at the beginning vs. at the end of study.
Time frame: 3 month
Assessment of the effect of heart failure therapy (left ventricular reverse remodelation) by evaluation of changes in LVEF echocardiographic parameter
Evaluation of changes in LVEDD echocardiographic parameter at the beginning vs. at the end of study.
Time frame: 3 month
Assessment of the effect of heart failure therapy (left ventricular reverse remodelation) by evaluation of changes in LVEDD echocardiographic parameter
Evaluation of changes in LVESD echocardiographic parameter at the beginning vs. at the end of study.
Time frame: 3 month
Assessment of the effect of heart failure therapy (left ventricular reverse remodelation) by evaluation of changes in LVESD echocardiographic parameter
Evaluation of changes in LAVi echocardiographic parameter at the beginning vs. at the end of study.
Time frame: 3 month
Assessment of the effect of heart failure therapy (left ventricular reverse remodelation) by evaluation of changes in LAVi echocardiographic parameter
Evaluation of changes in diastolic dysfunction by echocardiography at the beginning vs. at the end of study.
Time frame: 3 month
Assessment of the effect of heart failure therapy (left ventricular reverse remodelation) by evaluation of changes in diastolic dysfunction.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Individual participant dataSharing planned: 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by University Hospital Olomouc at 1 site in Czechia.
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 1 inclusion and 10 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: finished, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the effect of step telemonitoring during uptitration of heart failure medication. (time frame: 3 month). The study lists 12 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 29 Jan 2024.