RESynchronizaTiOn theRapy and bEta-blocker Titration

NCT02173028 | Completed

• 1 other identifier: Rif. n. 89/11 - 2011/0043537
• Study Type: observational
• Target: 254
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Beta Blocker Intolerance; Congestive Heart Failure

Keywords

Beta Blocker Intolerance;; Remote Patient Management system;; Cardiac Resynchronization Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Beta-blocker Titration with telemedicine system

  3 months

• Clinical response to CRT

  12 months

Study Arms (2)

Optimal beta blocker titration

We will compare the efficacy of two management strategies for beta-blocker up-titration: Standard in-office visits vs. Remote follow-up.

Without optimal titration of beta blocker

This analysis will be conducted within the Cardiac Resynchronization Therapy observational study Modular Registry (CRT MORE - ClinicalTrials.gov Identifier: NCT01573091).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients successfully implanted with CRT-D according to current European guidelines, on optimal therapy for heart failure (diuretics, ACE inhibitors and aldosterone antagonists), with stable dose in the previous month.

You may qualify if:

• 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 ;
• years or above

You may not qualify if:

• 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.

Sponsors & Collaborators

• Giuseppe Ricciardi: lead

Study Sites (4)

Policlinico Casilino

Rome, RM, 00100, Italy

Location

Ospedale Monaldi SUN

Napoli, 80131, Italy

Location

Ospedale Monaldi

Napoli, 80131, Italy

Location

Policlinico Federico II

Napoli, Italy

Location

Related Publications (1)

• D'Onofrio A, Palmisano P, Rapacciuolo A, Ammendola E, Calo L, Ruocco A, Bianchi V, Maresca F, Del Giorno G, Martino A, Mauro C, Campari M, Valsecchi S, Accogli M. Effectiveness of a management program for outpatient clinic or remote titration of beta-blockers in CRT patients: The RESTORE study. Int J Cardiol. 2017 Jun 1;236:290-295. doi: 10.1016/j.ijcard.2017.02.015. Epub 2017 Feb 5.

  PMID: 28188000 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Edoardo Gronda

  MultiMedica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 23, 2014
• First Posted: June 24, 2014
• Study Start: June 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: February 24, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)