Chronic Heart Failure With Low Ejection FractionBOT-IMPROVE-HFNCT06304753
ContriBution of Digital RemOte MoniToring to IMPROVing The Effectiveness of Treatment in Patients With Chronic Heart Failure With Low Ejection Fraction
A study testing Telebot in people with Chronic Heart Failure With Low Ejection Fraction, run by I.M. Sechenov First Moscow State Medical University at 2 sites in Russia.
Trial summary
BOT-IMPROVE-HF is a two-center, parallel group study designed to evaluate the efficacy of up-titration of heart failure treatment using digital remote monitoring after hospitalization due to heart failure decompensation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Heart Failure With Low Ejection Fraction
- What is being tested?
- Telebot
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesRussia
- Study dates
- 27 Oct 2023to 1 Dec 2025
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 and < 85 years
- HFrEF diagnosed according to 2020 Clinical practice guidelines for Chronic heart failure of Russian Society of Cardiology (RSC)
- Hospital admission within the 72 hours prior to Screening for acute heart failure with dyspnea at rest and pulmonary congestion on chest X-ray, and other signs and/or symptoms of heart failure such as edema and/or positive rales on auscultation.
- Stable condition at the time of discharge from the hospital
- All measures within 24 hours prior to Randomization of systolic blood pressure ≥ 100 mmHg, and of heart rate ≥ 60 bpm.
- All measures within 24 hours prior to Randomization of serum potassium ≤ 5.0 mmol/L.
Show all 25Show fewer
- At the moment of Randomization either (a) <= ½ the optimal dose of ACEi/ARB/ARNi (see Table) prescribed, no beta-blocker prescribed, and <= ½ the optimal dose of MRA prescribed or (b) no ACEi/ARB/ARNi prescribed, <= ½ the optimal dose of beta-blocker prescribed, and <= ½ the optimal dose of MRA prescribed.
- A smartphone with Internet access
- Written informed consent to participate in the study.
- Non-inclusion Criteria:
- Age < 18 or > 85 years.
- Stroke or transient ischemic attack (TIA) within the 3 months prior to Screening.
- Primary liver disease considered to be life threatening.
- Active infection at any time during the AHF hospitalization prior to Randomization based on abnormal temperature and elevated white blood cells (WBC) or need for intravenous antibiotics.
- Psychiatric or neurological disorder, cirrhosis, or active malignancy leading to a life expectancy < 6 months.
- Alcohol or drug abuse
- Pregnant or nursing (lactating) women.
- Serious vision and/or hearing problems
- Renal disease or estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2 [as estimated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) or the simplified Modification of Diet in Renal Disease (MDRD) formula] at Screening or history of dialysis.
- Clearly documented intolerance or contraindication to any of beta-blockers, renin-angiotensin system (RAS) blockers (both ACEi and ARB), angiotensin receptor neprilysin inhibitor (ARNi), mineralocorticoid receptor antagonist (MRAs).
- Significant pulmonary disease contributing substantially to the patients' dyspnea such as forced expiratory volume during the 1st second (FEV1)< 1 liter or need for chronic systemic or nonsystemic steroid therapy, or any kind of primary right heart failure such as primary pulmonary hypertension or recurrent pulmonary embolism.
- Myocardial infarction, unstable angina or cardiac surgery within 3 months, or cardiac resynchronization therapy (CRT) device implantation within 3 months, or percutaneous transluminal coronary intervention (PTCI), within 1 month prior to Screening.
- Uncorrected thyroid disease, active myocarditis, or known amyloid or hypertrophic obstructive cardiomyopathy.
- History of heart transplant or on a transplant list, or using or planned to be implanted with a ventricular assist device.
- Inability to comply with all study requirements, due to major co-morbidities, social or financial issues, or a history of noncompliance with medical regimens, that might compromise the patient's ability to understand and/or comply with the protocol instructions or follow-up procedures
Who cannot join
- Unwillingness of the patient to continue participating in the study
- The development of conditions related to the criteria of non-inclusion
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
Hospital Therapy No. 1 Department, University Clinical Hospital No. 1, Sechenov University
Moscow, 119435
State Budgetary Institution of Healthcare of Moscow "A.K. Yeramishantsev City Clinical Hospital of the Department of Healthcare of Moscow".
Moscow, 129327
About this study
BOT-IMPROVE-HF is a two-center, parallel group study designed to evaluate the efficacy of up-titration of heart failure treatment using digital remote monitoring after hospitalization due to heart failure decompensation. Patient will be randomized before discharge using a simple computer generated sequence to either remote monitoring or usual care group. Patients' condition in the "remote monitoring" arm will be assessed by mini-program based on a personal messenger and laboratory rests results will be asked by phone call. If these measures show safety and tolerability of the doses of the drugs, they will be increased to target or maximally tolerated doses. The follow-up period will be 6 months - 24 weeks. Patients of the usual care group will be followed by their general practitioner and/or cardiologist. All patients will be contacted after 6 months to assess outcomes.
Read the detailed description
The effectiveness of treatment in patients with chronic heart failure depends on the achievement of target doses of guideline-directed medical therapy. According to the STRONG-HF study, intensive titration for 6 months leads the decrease of hospitalization and mortality. But modern studies shows that only 17% of patients take the four drugs. And the percentage of achievement the target doses is probably even lower. A promising way to solve the problem is remote monitoring. And the investigator developed a program for this. This is a mini-program based on a personal messenger, which is controlled by text commands in a chat on the "question-answer" principle. It allows us to automate data collection and obtain information about the patient's well-being and his vital signs (blood pressure, heart rate, weight) related to heart failure. The pilot trial showed a good program adherence and a significant improvement in quality of life over a three-month period in the remote observation group. BOT-IMPROVE-HF is a multicenter, randomized, parallel group study aimed to evaluate the efficacy and safety of up-titration of heart failure medical therapy including beta-blockers; angiotensin converting enzyme inhibitors (ACEi), angiotensin receptor blocker (ARB) or angiotensin receptor neprilysin inhibitor (ARNi); and mineralocorticoid receptor antagonist (MRAs) using digital remote monitoring. Patients should be admitted for decompensation of chronic heart failure including clinical signs of congestion and elevated circulating N-terminal pro-B-type natriuretic peptide (NT-proBNP), Also they should not get optimal doses of oral heart failure (HF) therapies before discharge. Hemodynamically stable patients will be randomized to either remote monitoring or usual care group. In the first group, repeated assessments of clinical signs and symptoms of heart failure will be collected by a chatbot. Routine clinical laboratory measures including potassium, sodium, and creatinine as well as NT-proBNP will be performed by patients and collected by the chatbot or phone. It will allow us to titrate or continue oral HF therapies. The usual care group will be followed by their general practitioner and/or cardiologist. Patients will be contacted after 6 months to assess outcomes.
- Being tested
- Telebot
- Keywords
- heart failure, remote monitoring, adherence, mHealth, 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.
TelebotDevice
This is a mini-program based on a personal messenger, which is controlled by text commands in a chat on the "question-answer" principle. It allows us to automate data collection and obtain information about the patient's well-being and his vital signs (blood pressure, heart rate, weight) related to heart failure.
Follow-up and management of heart failure medications provided by specialists at participating institutions. Doses of oral heart failure medications optimized within 6 weeks, provided clinical assessments and laboratory measures indicate that it is safe to increase doses.
| Study group | Role | What they receive |
|---|---|---|
| Remote Monitoring | Experimental | Patients with chronic heart failure with low ejection fraction who was hospitalized due to decompensation of their condition. Their condition should be stabilized and blood pressure and renal function (Potassium level and eGFR) should be sufficient for titration of drugs. They should also have a smartphone with internet access.
Follow-up and management of heart failure medications provided by specialists at participating institutions. Doses of oral heart failure medications optimized within 6 weeks, provided clinical assessments and laboratory measures indicate that it is safe to increase doses. Receives: Device: Telebot |
| Usual Care | No intervention | Patients with chronic heart failure with low ejection fraction who was hospitalized due to decompensation of their condition. Their condition should be stabilized and blood pressure and renal function (Potassium level and eGFR) should be sufficient for titration of drugs. They should also have a smartphone with internet access. Follow-up and management of heart failure medications provided by the patient's general physician and/or cardiologist according to local medical standards |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Mortality rate
Measured: an average, 6 months after randomization
Heart failure decompensation
Frequency of worsening heart failure leads to hospitalization or administration of parenteral loop diuretics
Measured: an average, 6 months after randomization
Secondary outcomes (3)
Change in NT-proBNP
Change in NT-proBNP on the log scale
Measured: an average, 6 months after randomization
Change in Quality of life
Change in quality of life as measured using the The Minnesota living with heart failure questionnaire (MLHFQ) scale which ranges from 0 to 100 with a higher score representing a better outcome.
Measured: an average, 6 months after randomization
Changes in medical adherence
Change in amount of taking drugs and doses with a higher score representing a better outcome
Measured: an average, from 6 weeks to 180 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start27 Oct 2023
- Primary completion1 Jun 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart Failure With Low Ejection FractionStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aleksei Emelianov, Principal investigator, I.M. Sechenov First Moscow State Medical University (Sechenov University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304753
- Sponsor's protocol ID
- BOT119435
- Acronym
- BOT-IMPROVE-HF
- Status last verified
- May 2026
- First submitted
- 4 Mar 2024
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to the Local Ethics Committee's rules, we are not allowed to provide this data.
Publications
Kozhevnikova MV, Emelianov AV, Zheleznykh EA, Pavlov NA, Khabarova NV, Belenkov YN. Impact of Digital Remote Monitoring on the Optimization of Guideline-Directed Medical Therapy Titration in Heart Failure With Reduced Ejection Fraction. Kardiologiia. 2026 Apr 2;66(2):21-30. doi: 10.18087/cardio.2026.2.n3105. English, Russian.
PubMed 41925172Emel'yanov A, Zheleznykh E, Kozhevnikova M, Zektser V, Kamalova A, Privalova E, Belenkov Y. INFLUENCE OF REMOTE DIGITAL OBSERVATIONS ON QUALITY OF LIFE, COMPLIANCE, AND CLINICAL OUTCOMES IN PATIENTS WITH CHRONIC HEART FAILURE. Biomedical Engineering. 2024/01; 57(5):311-315. doi: 10.1007/s10527-023-10322-7.
Emelianov, A. V., Zheleznykh, E. A., Kozhevnikova, M. V., Ageev, A. A., Zektser, V. Y., & Belenkov, Y. N. (2023). Quality of life and adherence to therapy in patients with chronic heart failure who were remotely monitored by chatbot compared to the standard follow-up group for 3 months. Digital Diagnostics, 4(1S), 53-56. doi: 10.17816/DD430343
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ContriBution of Digital RemOte MoniToring to IMPROVing The Effectiveness of Treatment in Patients With Chronic Heart Failure With Low Ejection Fraction
- ClinicalTrials.gov ID
- NCT06304753
- Acronym / sponsor ID
- BOT-IMPROVE-HF / BOT119435
- Keywords
- heart failure, remote monitoring, adherence, mHealth, telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 27 Oct 2023 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 12 Mar 2024 (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.
BOT-IMPROVE-HF is a two-center, parallel group study designed to evaluate the efficacy of up-titration of heart failure treatment using digital remote monitoring after hospitalization due to heart failure decompensation. Patient will be randomized before discharge using a simple computer generated sequence to either remote monitoring or usual care group. Patients' condition in the "remote monitoring" arm will be assessed by mini-program based on a personal messenger and laboratory rests results will be asked by phone call. If these measures show safety and tolerability of the doses of the drugs, they will be increased to target or maximally tolerated doses. The follow-up period will be 6 months - 24 weeks. Patients of the usual care group will be followed by their general practitioner and/or cardiologist. All patients will be contacted after 6 months to assess outcomes.
Detailed description
The effectiveness of treatment in patients with chronic heart failure depends on the achievement of target doses of guideline-directed medical therapy. According to the STRONG-HF study, intensive titration for 6 months leads the decrease of hospitalization and mortality. But modern studies shows that only 17% of patients take the four drugs. And the percentage of achievement the target doses is probably even lower. A promising way to solve the problem is remote monitoring. And the investigator developed a program for this. This is a mini-program based on a personal messenger, which is controlled by text commands in a chat on the "question-answer" principle. It allows us to automate data collection and obtain information about the patient's well-being and his vital signs (blood pressure, heart rate, weight) related to heart failure. The pilot trial showed a good program adherence and a significant improvement in quality of life over a three-month period in the remote observation group. BOT-IMPROVE-HF is a multicenter, randomized, parallel group study aimed to evaluate the efficacy and safety of up-titration of heart failure medical therapy including beta-blockers; angiotensin converting enzyme inhibitors (ACEi), angiotensin receptor blocker (ARB) or angiotensin receptor neprilysin inhibitor (ARNi); and mineralocorticoid receptor antagonist (MRAs) using digital remote monitoring. Patients should be admitted for decompensation of chronic heart failure including clinical signs of congestion and elevated circulating N-terminal pro-B-type natriuretic peptide (NT-proBNP), Also they should not get optimal doses of oral heart failure (HF) therapies before discharge. Hemodynamically stable patients will be randomized to either remote monitoring or usual care group. In the first group, repeated assessments of clinical signs and symptoms of heart failure will be collected by a chatbot. Routine clinical laboratory measures including potassium, sodium, and creatinine as well as NT-proBNP will be performed by patients and collected by the chatbot or phone. It will allow us to titrate or continue oral HF therapies. The usual care group will be followed by their general practitioner and/or cardiologist. Patients will be contacted after 6 months to assess outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote Monitoring | Experimental | Device: TelebotPatients with chronic heart failure with low ejection fraction who was hospitalized due to decompensation of their condition. Their condition should be stabilized and blood pressure and renal function (Potassium level and eGFR) should be sufficient for titration of drugs. They should also have a smartphone with internet access. Follow-up and management of heart failure medications provided by specialists at participating institutions. Doses of oral heart failure medications optimized within 6 weeks, provided clinical assessments and laboratory measures indicate that it is safe to increase doses. |
| Usual Care | No intervention | –Patients with chronic heart failure with low ejection fraction who was hospitalized due to decompensation of their condition. Their condition should be stabilized and blood pressure and renal function (Potassium level and eGFR) should be sufficient for titration of drugs. They should also have a smartphone with internet access. Follow-up and management of heart failure medications provided by the patient's general physician and/or cardiologist according to local medical standards |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Age > 18 and < 85 years
- HFrEF diagnosed according to 2020 Clinical practice guidelines for Chronic heart failure of Russian Society of Cardiology (RSC)
- Hospital admission within the 72 hours prior to Screening for acute heart failure with dyspnea at rest and pulmonary congestion on chest X-ray, and other signs and/or symptoms of heart failure such as edema and/or positive rales on auscultation.
- Stable condition at the time of discharge from the hospital
- All measures within 24 hours prior to Randomization of systolic blood pressure ≥ 100 mmHg, and of heart rate ≥ 60 bpm.
Key exclusion criteria (2 listed)
- Unwillingness of the patient to continue participating in the study
- The development of conditions related to the criteria of non-inclusion
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 |
|---|---|---|
| TelebotThis is a mini-program based on a personal messenger, which is controlled by text commands in a chat on the "question-answer" principle. It allows us to automate data collection and obtain information about the patient's well-being and his vital signs (blood pressure, heart rate, weight) related to heart failure. Follow-up and management of heart failure medications provided by specialists at participating institutions. Doses of oral heart failure medications optimized within 6 weeks, provided clinical assessments and laboratory measures indicate that it is safe to increase doses. | Device | Remote Monitoring |
Primary outcome
All-cause mortality
Time frame: an average, 6 months after randomization
Mortality rate
Heart failure decompensation
Time frame: an average, 6 months after randomization
Frequency of worsening heart failure leads to hospitalization or administration of parenteral loop diuretics
3 secondary outcomes
Change in NT-proBNP
Time frame: an average, 6 months after randomization
Change in Quality of life
Time frame: an average, 6 months after randomization
Changes in medical adherence
Time frame: an average, from 6 weeks to 180 days after randomization
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 26 May 2026.
- Results publication: PubMed 41925172Kozhevnikova MV, Emelianov AV, Zheleznykh EA, Pavlov NA, Khabarova NV, Belenkov YN. Impact of Digital Remote Monitoring on the Optimization of Guideline-Directed Medical Therapy Titration in Heart Failure With Reduced Ejection Fraction. Kardiologiia. 2026 Apr 2;66(2):21-30. doi: 10.18087/cardio.2026.2.n3105. English, Russian.
- Results publicationEmel'yanov A, Zheleznykh E, Kozhevnikova M, Zektser V, Kamalova A, Privalova E, Belenkov Y. INFLUENCE OF REMOTE DIGITAL OBSERVATIONS ON QUALITY OF LIFE, COMPLIANCE, AND CLINICAL OUTCOMES IN PATIENTS WITH CHRONIC HEART FAILURE. Biomedical Engineering. 2024/01; 57(5):311-315. doi: 10.1007/s10527-023-10322-7.
- Results publicationEmelianov, A. V., Zheleznykh, E. A., Kozhevnikova, M. V., Ageev, A. A., Zektser, V. Y., & Belenkov, Y. N. (2023). Quality of life and adherence to therapy in patients with chronic heart failure who were remotely monitored by chatbot compared to the standard follow-up group for 3 months. Digital Diagnostics, 4(1S), 53-56. doi: 10.17816/DD430343
- Individual participant dataSharing planned: No. According to the Local Ethics Committee's rules, we are not allowed to provide this data.
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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.
Aleksei Emelianov principal investigator
I.M. Sechenov First Moscow State Medical University (Sechenov University)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telebot in people with Chronic Heart Failure With Low Ejection Fraction, run by I.M. Sechenov First Moscow State Medical University at 2 sites in Russia.
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 25 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: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. 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?
All-cause mortality (time frame: an average, 6 months after randomization). 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?
On the ClinicalTrials.gov record for NCT06304753, which also lists 3 linked publications.
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 26 May 2026.