Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06304753
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-03-04
Brief Title:
ContriBution of Digital RemOte MoniToring to IMPROVing The Effectiveness of Treatment in Patients With Chronic Heart Failure With Low Ejection Fraction
Sponsor:
IM Sechenov First Moscow State Medical University
Organization:
IM Sechenov First Moscow State Medical University
Study Overview
Official Title:
ContriBution of Digital RemOte MoniToring to IMPROVing The Effectiveness of Treatment in Patients With Chronic Heart Failure With Low Ejection Fraction
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BOT-IMPROVE-HF
Brief 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 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 andor 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 patients 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 andor cardiologist Patients will be contacted after 6 months to assess outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None