RESTORECardiac Resynchronization Therapy for Beta-Blocker Titration in Heart Failure
This observational study aims to demonstrate how Cardiac Resynchronization Therapy (CRT) can help in achieving the optimal dosage of beta-blockers (carvedilol or bisoprolol) in heart failure patients who are already on maximum doses of beta-blockers and meet the criteria for CRT as per international guidelines.
Data Collection
Collected from today forward - ProspectiveCardiovascular Diseases
+ Heart Diseases
+ Heart Failure
Case-Control
Comparing exposures between individuals with and without disease in order to identify potential risk factors.Summary
Study start date: June 1, 2013
Actual date on which the first participant was enrolled.This study focuses on improving treatment for chronic heart failure, a condition where the heart can't pump blood as effectively as it should. Current treatments involve the use of ACE inhibitors and beta-blockers, like carvedilol or bisoprolol. However, some patients may not tolerate these medications well, and many aren't receiving the doses proven effective in previous clinical trials. The study aims to show that cardiac resynchronization therapy (CRT) can help patients reach the optimal dosage of beta-blockers, even if they're currently on maximum doses and meet international guidelines for CRT. This could lead to better management of heart failure. The main goal is to demonstrate that CRT can help adjust beta-blocker dosages (carvedilol or bisoprolol) to the optimal level, or at least to the effective dose, for heart failure patients already on maximum beta-blocker doses. The study also aims to evaluate the effectiveness of remote monitoring using a telemedicine system for automatically adjusting beta-blocker doses, compared to the standard approach of regular outpatient visits. The clinical response to CRT will be assessed based on whether patients are on the optimal or sub-optimal dosage of beta-blockers.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.254 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-Control
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 4 locations
Ospedale Monaldi SUN
Napoli, ItalyOspedale Monaldi
Napoli, ItalyPoliclinico Federico II
Napoli, Italy