RESynchronizaTiOn theRapy and bEta-blocker Titration

Congestive Heart Failure Clinical Trial

— RESTORE  

Official title:

RESynchronizaTiOn theRapy and bEta-blocker Titration : RESTORE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02173028
• Other study ID #: Rif. n. 89/11 - 2011/0043537
• Status: Completed
• Phase: N/A
• First received: June 23, 2014
• Last updated: February 22, 2017
• Start date: June 2013
• Est. completion date: July 2015

Study information

• Verified date: February 2017
• Source: University of Florence
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients will be treated according to the clinical practice of the participating centers and to the international guidelines for the treatment of heart failure.The present analysis provides a collection of data about the changes to drug therapy after the "Cardiac Resynchronization Therapy" (CRT) procedure , and any signs and symptoms of intolerance to prescribed medications.

Description:

The treatment of chronic heart failure is currently based on the use of ACE (Angiotensin Converting Enzyme) inhibitors and beta-blockers. Although this therapy is universally accepted up to 10-20% of patients may be intolerant. Moreover, the majority of patients are not treated with the doses that have been shown to be effective in controlled clinical trials. Although it is possible that even low doses of neurohumoral inhibitors are still effective than placebo, a greater benefit can be obtained at maximum doses. Therefore, it is generally recommended that these agents are used at recommended doses found to be effective in controlled studies. There are many reasons for the lack of prescription neurohumoral inhibitors and their use in non-optimal doses. These include both an inadequate clinical management, and low tolerance to drugs. As far as beta-blockers, their poor tolerability has at least two main causes: 1) the effects not related to heart failure (eg, bradycardia, AtrioVentricular (AV) block, bronchial asthma), 2) the acute negative inotropic effects, which can cause a further deterioration of hemodynamic parameters.

The primary objective of the analysis is to demonstrate that cardiac resynchronization therapy (CRT) may allow titration of beta-blockers (carvedilol or bisoprolol) until the optimal dosage, or at least to the effective dose, in patients with heart failure treated to maximal doses of beta-blockers and with the indications for CRT according to current international guidelines.

The secondary objective is to evaluate the effectiveness of remote monitoring with a telemedicine system to facilitate the automatic titration of beta-blockers in comparison with the standard approach, which consists of periodic outpatient visits. The strategy adopted will depend on the availability of remote monitoring systems and standard clinical practice of each participating center.

In addition, we will evaluate the clinical response to CRT, depending on the optimal or sub-optimal dosage of beta-blockers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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%;

• Duration of ventricular depolarization wave (QRS) = 120ms (NYHA III or IV) or = 150ms in NYHA II;

• Patients with chronic atrial fibrillation will be eligible for the study only if they undergo ablation ;

• 18 years or above

Exclusion Criteria:

• Failure to comply with the scheduled follow-up;

• Life expectancy less than 12 months ;

• Pregnant women;

• Tricuspid valve mechanics;

• Severe aortic stenosis or other valve disease ;

• Patients already receiving CRT.

Related Conditions & MeSH terms

• Beta Blocker Intolerance
• Congestive Heart Failure
• Heart Failure

Locations

Country	Name	City	State
Italy	Ospedale Monaldi	Napoli
Italy	Ospedale Monaldi SUN	Napoli
Italy	Policlinico Federico II	Napoli
Italy	Policlinico Casilino	Rome	RM

Sponsors (1)

Lead Sponsor	Collaborator
Giuseppe Ricciardi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optimal beta-blockers titration due to CRT	The primary objective of the analysis is to demonstrate that cardiac resynchronization therapy (CRT) may allow titration of beta-blockers (carvedilol or bisoprolol) until the optimal dosage, or at least to the effective dose, in patients with heart failure treated to maximal doses of beta-blockers and with the indications for CRT according to current international guidelines.The goal is to achieve the optimal dosage of 10mg/die of bisoprolol or 50mg/die of carvedilol, or at least the recommended dose (carvedilol 37.5 mg / day or bisoprolol 7.5 mg), as shown in international treatment guidelines.	3 months
Secondary	Beta-blocker Titration with telemedicine system	The secondary objective is to evaluate the effectiveness of a Remote Patient Management (RPM) system to optimize the titration of beta-blockers in comparison with the standard approach, which consists of periodic in -hospital visits.	3 months
Secondary	Clinical response to CRT	The response will be measured at 3 and 12 months in terms of: Amount of reverse remodeling of the left ventricle; Changes in NYHA (New York Heart Association) functional class; Ventricular arrhythmias treated by the Implantable Cardioverter Defibrillator (ICD); Adverse cardiovascular events (cardiovascular hospitalization, heart failure hospitalization) and mortality from all causes.	12 months