CHFEarly Phase 1ERICA-HFNCT04591964
Effects of Remote Monitoring of Patients With Heart Failure Based on Smartphone Application
A Early Phase 1 study testing mobile application "M-Cardio" based on android in people with CHF, run by National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov at 1 site in Kyrgyzstan.
Trial summary
CHF is a most wild-spread and prognostically poor outcome most of cardiovascular and other disease. Despite of significant progress in treatment of CHF for the last years, death from this pathology stayed very high, reaching 60% for men, 45% for women during the 5 years after establishing diagnosis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- CHF
- What is being tested?
- mobile application "M-Cardio" based on android
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteKyrgyzstan
- Study dates
- 1 Jan 2021to 31 Dec 2023
- Phase
- Early Phase 1
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or over (not older 70 y.o)
- Participant willing and able to give informed consent
- Documented Coronary artery disease (CAD): either angio-graphically documented CAD or a previous history of myocardial infarction/angina.
- Verified heart failure functional class III (Nt-proBNP levels, 6-min walking test).
- Receiving basic therapy for CAD and chronic heart failure (CHF).
- Able (in the investigators opinion) and willing to comply with all study requirements.
Who cannot join
- Cognitive impairments.
- Unstable course of CAD.
- Acute heart failure or CHF decompensation.
- Malignancy (receiving active treatment) or other life threatening disease.
- Renal dysfunction (stage 3B or worse).
- Thyroid dysfunction.
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- Pregnancy/lactating females.
- Any other reason considered inappropriate by a study physician.
- Participants who have participated in any other clinical trial within the previous 30 days
Trial locations and contacts
1 site in 1 country.
Kyrgyzstan1 site, 1 recruiting
- Recruiting
National Centre of Cardiology and Internal Medicine named after academician M.Mirrakhimov
Bishkek, 720001
Akbay Sarybaev, MD, prof, +996312625686, info@nccim.kg
Ernest Djyshambaev, MD, prof, +996555644707, ernestdd1958@mail.ru
About this study
Official title: Effects of Remote Monitoring of Patients With Heart Failure Based on Smartphone Application: Open-labled Randomized Clinical Trial.
CHF is a most wild-spread and prognostically poor outcome most of cardiovascular and other disease. Despite of significant progress in treatment of CHF for the last years, death from this pathology stayed very high, reaching 60% for men, 45% for women during the 5 years after establishing diagnosis. The purpose of treatment is creating "seamless" system of care the whole continuum stretch CHF, in this connection, the particular relevance take in creating of new way and strategy with IT-technology mHealth. On the whole, mHealth application potentially suggest economic efficiency solution with continuous access for symptoms monitoring, stimulation of patients to self-servicing, self-controlling and achieving better results compare with optimal medical therapy. So, remote monitoring of patients on the base of mobile application must improve clinical and economic efficiency of medical care received.
In trial will be studied efficiency of using mobile application for remote monitoring of patients with ischemic etiology HF, also quality of life, commitment to therapy and prognosis (frequency of cardiovascular poor outcomes). Clinical indicators and tests (Quality of Life Minnesota Living with Heart Failure Questionnaire, Hospital Anxiety and Depression Scale, 6-minute walking test) will be evaluated in the beginning of the trial and repeatly after 1 year.
Trial financed by Kyrgyz Republic Ministry of Education and Science.
Read the detailed description
It is single-centered, open-labled, comparative, prospective, randomized clinical trial, intended to study the benefits, if that's have, 12-month remote monitoring with using mobile application based on chronic heart failure clinical flow of 200 patients with coronary heart disease.
Participants will seen twice: screening, initial randomization, last 12 month, during which will be evaluated clinical and laboratory indicators. At the time of first screening visit will be singed informed consent. In the department of chronic heart failure of National Center of Cardiology and Internal Medicine named by M. Mirrakhimov the patients will be laboratory and clinical-instrumentary examined and have been teaching for using mobile application, basics of self-servicing and self-controlling. Participants, meeting all inclusion criteria, will come back for randomization during the hospitalization or just to standard medical therapy, or to standard medical therapy and remote monitoring with mobile application. In active comparator patients besides of standard medical therapy will use mobile application twice a week, if necessary every day, also foreseen two-way feedback with the coordinating doctor and online chat on WhatsApp.
- Conditions
- CHF
- Being tested
- mobile application "M-Cardio" based on android
- Keywords
- Chronic heart failure, telemedicine, mobile health, mobile application, remote monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile application "M-Cardio" based on androidCombination product
Mobile apllication "M-Cardio" (android) for remote monitoring of patients with CHF developed on algorithms of clinical indicators, that's give us to evaluate current condition of patient, depends from quantity points of abnormals higher or lower threshold values, with automatically notification for doctor and patient for timely medical service.
| Study group | Role | What they receive |
|---|---|---|
| baseline | Active comparator | standard medical therapy + using of mobile application + improving therapy Receives: Combination Product: mobile application "M-Cardio" based on android |
| Control | No intervention | standard medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause death
fixation of reaching the primary endpoint All-cause death
Measured: 12 month
Recurrent hospitalizations due to chronic heart failure decompensation and/or non-fatal acute coronary syndrome.
fixation of reaching the primary endpoint recurrent hospitalizations due to chronic heart failure decompensation and/or non-fatal acute coronary syndrome.
Measured: 12 month
Secondary outcomes (3)
Quality of Life assesed Minnesota LIVING WITH HEART FAILURE Questionnaire (MLHFQ)
The questionnaire is comprised of 21 questions around several physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. After receiving brief standardized instructions, the patient marks a 0 (zero) to 5 (five) scale to indicate the extent to which each itemized adversity of heart failure has prevented the patient from living as they wanted to live during the past 4 weeks. The questionnaire is simply scored by summation of all 21 responses.
This questionnaire can be used as a key outcome measure in studies and evaluations of outpatients with symptomatic (NYHA class II to IV) heart failure with a reduced or preserved ejection fraction. This patient-reported outcome measurement tool can be used to determine whether a treatment for heart failure is effective for improving patients' quality of life by reducing the adverse impact of heart failure.
Measured: 12 month
6-minute walking test results
The test is based on measuring the walking distance with turns along a long corridor (≥30 m) at the patient's own pace. Results will be evaluated at baseline and at 12 months
Measured: 12 month
Nt-proBNP levels
Nt-proBNP levels will be evaluated while using mobile application for remote monitoring compared to lifestyle modification in patients with ischemic etiology CHF
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Jan 2021
- Primary completion1 Jun 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CHFStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional, prospective, open-labled, comparative, randomized clinical trial. Baseline group: standard medical treatment + using of mobile application for remote monitoring, base of self-controlling, 12 month. Control group: standard medical treatment + base of self-controlling.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Akmaral Rustambekovna, National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
- Investigators
- Aigul Noruzbaeva, professor, Study director, Head of CHF department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591964
- Sponsor's protocol ID
- 0007188
- Acronym
- ERICA-HF
- Status last verified
- Apr 2022
- First submitted
- 24 Sep 2020
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Remote Monitoring of Patients With Heart Failure Based on Smartphone Application: Open-labled Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04591964
- Acronym / sponsor ID
- ERICA-HF / 0007188
- Conditions
- CHF
- Keywords
- Chronic heart failure, telemedicine, mobile health, mobile application, remote monitoring
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Center of Cardiology and Internal Medicine named after academician M.MirrakhimovOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 19 Oct 2020 (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.
CHF is a most wild-spread and prognostically poor outcome most of cardiovascular and other disease. Despite of significant progress in treatment of CHF for the last years, death from this pathology stayed very high, reaching 60% for men, 45% for women during the 5 years after establishing diagnosis. The purpose of treatment is creating "seamless" system of care the whole continuum stretch CHF, in this connection, the particular relevance take in creating of new way and strategy with IT-technology mHealth. On the whole, mHealth application potentially suggest economic efficiency solution with continuous access for symptoms monitoring, stimulation of patients to self-servicing, self-controlling and achieving better results compare with optimal medical therapy. So, remote monitoring of patients on the base of mobile application must improve clinical and economic efficiency of medical care received.
In trial will be studied efficiency of using mobile application for remote monitoring of patients with ischemic etiology HF, also quality of life, commitment to therapy and prognosis (frequency of cardiovascular poor outcomes). Clinical indicators and tests (Quality of Life Minnesota Living with Heart Failure Questionnaire, Hospital Anxiety and Depression Scale, 6-minute walking test) will be evaluated in the beginning of the trial and repeatly after 1 year.
Trial financed by Kyrgyz Republic Ministry of Education and Science.
Detailed description
It is single-centered, open-labled, comparative, prospective, randomized clinical trial, intended to study the benefits, if that's have, 12-month remote monitoring with using mobile application based on chronic heart failure clinical flow of 200 patients with coronary heart disease.
Participants will seen twice: screening, initial randomization, last 12 month, during which will be evaluated clinical and laboratory indicators. At the time of first screening visit will be singed informed consent. In the department of chronic heart failure of National Center of Cardiology and Internal Medicine named by M. Mirrakhimov the patients will be laboratory and clinical-instrumentary examined and have been teaching for using mobile application, basics of self-servicing and self-controlling. Participants, meeting all inclusion criteria, will come back for randomization during the hospitalization or just to standard medical therapy, or to standard medical therapy and remote monitoring with mobile application. In active comparator patients besides of standard medical therapy will use mobile application twice a week, if necessary every day, also foreseen two-way feedback with the coordinating doctor and online chat on WhatsApp.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional, prospective, open-labled, comparative, randomized clinical trial. Baseline group: standard medical treatment + using of mobile application for remote monitoring, base of self-controlling, 12 month. Control group: standard medical treatment + base of self-controlling.
| Arm | Type | Receives |
|---|---|---|
| baseline | Active comparator | Combination Product: mobile application "M-Cardio" based on androidstandard medical therapy + using of mobile application + improving therapy |
| Control | No intervention | –standard medical therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 years or over (not older 70 y.o)
- Participant willing and able to give informed consent
- Documented Coronary artery disease (CAD): either angio-graphically documented CAD or a previous history of myocardial infarction/angina.
- Verified heart failure functional class III (Nt-proBNP levels, 6-min walking test).
- Receiving basic therapy for CAD and chronic heart failure (CHF).
Key exclusion criteria (9 listed)
- Cognitive impairments.
- Unstable course of CAD.
- Acute heart failure or CHF decompensation.
- Malignancy (receiving active treatment) or other life threatening disease.
- Renal dysfunction (stage 3B or worse).
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 |
|---|---|---|
| mobile application "M-Cardio" based on androidMobile apllication "M-Cardio" (android) for remote monitoring of patients with CHF developed on algorithms of clinical indicators, that's give us to evaluate current condition of patient, depends from quantity points of abnormals higher or lower threshold values, with automatically notification for doctor and patient for timely medical service. | Combination product | baseline |
Primary outcome
All-cause death
Time frame: 12 month
fixation of reaching the primary endpoint All-cause death
Recurrent hospitalizations due to chronic heart failure decompensation and/or non-fatal acute coronary syndrome.
Time frame: 12 month
fixation of reaching the primary endpoint recurrent hospitalizations due to chronic heart failure decompensation and/or non-fatal acute coronary syndrome.
3 secondary outcomes
Quality of Life assesed Minnesota LIVING WITH HEART FAILURE Questionnaire (MLHFQ)
Time frame: 12 month
6-minute walking test results
Time frame: 12 month
Nt-proBNP levels
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- 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.
Aigul Noruzbaeva, professor study director
Head of CHF department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing mobile application "M-Cardio" based on android in people with CHF, run by National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov at 1 site in Kyrgyzstan.
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 6 inclusion and 9 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 13 Apr 2022. 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 Kyrgyzstan. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Akmaral Rustambekova, researcher (+996222505506, akmaral.rustambekova@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause death (time frame: 12 month). 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 13 Apr 2022.