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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telebot | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | Mortality rate | an average, 6 months after randomization |
| Heart failure decompensation | Frequency of worsening heart failure leads to hospitalization or administration of parenteral loop diuretics | an average, 6 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Change in NT-proBNP | Change in NT-proBNP on the log scale | 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. |
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Inclusion Criteria:
Non-inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aleksei Emelianov | I.M. Sechenov First Moscow State Medical University (Sechenov University) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Therapy No. 1 Department, University Clinical Hospital No. 1, Sechenov University | Moscow | 119435 | Russia | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41925172 | Result | 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. | |
| Result | Emel'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. | ||
| Result | 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 |
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According to the Local Ethics Committee's rules, we are not allowed to provide this data.
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|
| 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 | an average, from 6 weeks to 180 days after randomization |
| State Budgetary Institution of Healthcare of Moscow "A.K. Yeramishantsev City Clinical Hospital of the Department of Healthcare of Moscow". |
| Moscow |
| 129327 |
| Russia |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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