Completed

RESTORECardiac Resynchronization Therapy for Beta-Blocker Titration in Heart Failure

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Study Aim

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.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Cardiovascular Diseases

+ Heart Diseases

+ Heart Failure

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: June 2013
See protocol details

Summary

Principal SponsorGiuseppe Ricciardi
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleRESynchronizaTiOn theRapy and bEta-blocker Titration : RESTORE
NCT02173028
Principal SponsorGiuseppe Ricciardi
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

254 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Cardiovascular DiseasesHeart DiseasesHeart Failure

Criteria

7 inclusion criteria required to participate
Patients on optimal therapy for heart failure (diuretics, ACE inhibitors and aldosterone antagonists), with stable dose in the previous month;

Successfully implanted with CRT-D according to current European Society of Cardiology (ESC) guidelines;

New York Heart Association (NYHA) functional class: II, III and IV;

Left Ventricular Ejection Fraction (LVEF) ≤ 35%;

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6 exclusion criteria prevent from participating
Failure to comply with the scheduled follow-up;

Life expectancy less than 12 months ;

Pregnant women;

Tricuspid valve mechanics;

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

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

Suspended

Policlinico Casilino

Rome, ItalyOpen Policlinico Casilino in Google Maps
Suspended

Ospedale Monaldi SUN

Napoli, Italy
Suspended

Ospedale Monaldi

Napoli, Italy
Suspended

Policlinico Federico II

Napoli, Italy
Completed4 Study Centers