Cardiac Resynchronization Therapy Modular Registry (CRT-MORE)

The purpose of the study is to collect some parameters (clinical, electrical, radiographic, echocardiographic and ECG) able to predict response to cardiac resynchronization therapy.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Procedure: Cardiac Resynchronization Therapy

Detailed Description

Heart failure is a complex clinical syndrome characterized by a high prevalence and incidence in populations at greatest risk and, therefore, with a significant social and economic impact. Randomized clinical trials, meta-analyzes, observational studies and controlled trials clearly demonstrated that the neuro-hormonal therapy is highly effective in reducing mortality, hospitalization and improving quality of life. In recent years the electrical therapy is playing an increasingly important role in the treatment of patients with chronic heart failure. Such importance is mainly due to the possibility of preventing sudden cardiac death by implanting an ICD and to correct the deleterious effects of electrical dyssynchrony and / or left ventricular mechanics by CRT. The CRT has proven an effective tool in reducing mortality, reducing symptoms and improving quality of life in patients already receiving optimal medical therapy. Despite the undoubted benefits that the electrical treatment has added to conventional medical therapy, a high percentage of patients does not benefit in terms of clinical and echocardiographic. The identification of non-responders to CRT is crucial in order not to submit the patients to an unnecessary and costly device whose electrical therapy proves to be ineffective. The reason for lack of response is still unclear but factors such as lead placement, device-settings and the degree of dyssynchrony before implant seems to be important. The purpose of the study is to collect some parameters (clinical, electrical, radiographic, echocardiographic and ECG) able to predict response to cardiac resynchronization therapy.

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Italy
  • Biella, Italy, 61679
    • Ospedale degli Infermi
  • Brescia, Italy, 25124
    • Cardiovascular Department, Electrophysiology Unit, Istituto Ospedaliero Fondazione Poliambulanza
  • Florence, Italy, 50134
    • Department of Heart and Vessels, University of Florence
  • Gallarate, Italy, 21013
    • Department of Cardiology and Coronary Care Unit, Azienda Ospedaliera S. Antonio Abate
  • Mantova, Italy, 46100
    • Department of Cardio, Thoracic and Vascular, Azienda Ospedaliera Carlo Poma
  • Massa, Italy, 54100
    • San Giacomo e Cristoforo
  • Naples, Italy, 80122
    • Department of Heart, Electrophysiology, Clinica Mediterranea
  • Napoli, Italy, 80131
    • Azienda Ospedale dei Colli - Monaldi
  • Napoli, Italy
    • Policlinico Federico II
  • Padova, Italy, 61353
    • Azienda Ospedaliera di Padova
  • Pesaro, Italy, 61998
    • Azienda Ospedaliera San Salvatore
  • Prato, Italy, 59100
    • Department of Cardiology, Ospedale Civile "Misericordia e Dolce"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients eligible for CRT device implanted according to current guidelines

Description

Inclusion Criteria:

• Chronic symptomatic HF despite stable, optimal drug therapy
• Indication for a cardiac resynchronisation device with or without defibrillator backup according to current guidelines
• Patients implanted with cardiac resynchronization device

Exclusion Criteria:

• Patients participating in other studies that clearly impact the clinical practice of the center
• Patients who are unable to provide informed consent
• Patients who can not perform follow-up in the center

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Heart failure patients; Patients with a CRT device according to current guidelines	Procedure: Cardiac Resynchronization Therapy; Any commercially available Cardiac Resynchronization Therapy devices with or without defibrillation backup (CRT-D/CRT-P) can be used upon discretion of the investigator according to current guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical response	Improvement in functional class status by at least one NYHA Class or remain in functional class II	24 months
Echocardiographic response of absolute increase of ≥5% in LVEF	Patients at follow-up to 6-12 months show an increase of the absolute value of the LVEF than 5%	24 months
Echocardiographic response of ≥15% reduction in LVESV	Patients at follow-up to 6-12 months show a systolic volume (LVESV) reduction greater than 15%	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LV lead/RV lead geometric distance	To investigate the correlation of LV lead/RV lead geometric distance (as measured by fluoroscopy) and reverse remodeling in cardiac resynchronization therapy (as measured by echocardiography as defined in primary outcome measure) at 12 months. The relation with LVESVi change between baseline and 12 months will be analyzed.	12 months
Change from baseline in R wave in 12-lead ECG at 12 months	To investigate the relationship between the ECG characteristics at baseline and response to cardiac resynchronization therapy (as measured by echocardiography as defined in primary outcome measure) at 12 months. The purpose of this objective is to evaluate the R wave in 12-lead ECG during BIV, RV and LV pacing and change from baseline at 12 months.	12 months
Number of ventricular arrhythmias after cardiac resynchronization therapy	To investigate the relationship between LV pacing and the number of ventricular tachycardia/fibrillation and/or appropriate/inappropriate shocks. The number and type of arrhythmia before and after upgrading to CRT device at 24 months will be analyzed	24 months

Collaborators and Investigators

• Sponsor: Giuseppe Ricciardi
• Investigators: Study Chair: Luigi Padeletti, MD, Department of Heart and Vessels, University of Florence, Florence, Italy.

Publications and helpful links

General Publications

• Bertaglia E, Reggiani A, Palmisano P, D'Onofrio A, De Simone A, Caico SI, Pecora D, Arena G, Marini M, Ricciardi G, Badolati S, Spotti A, Solimene F, Ferraro A, Migliore F, Botto GL, Malacrida M, Stabile G. The stricter criteria for Class I CRT indication suggested by the 2016 ESC Guidelines reliably exclude patients with a worse prognosis in comparison with the 2013 ESC indication criteria. Int J Cardiol. 2018 Dec 15;273:162-167. doi: 10.1016/j.ijcard.2018.09.027. Epub 2018 Sep 8.
• Stabile G, Pepi P, Palmisano P, D'Onofrio A, De Simone A, Caico SI, Pecora D, Rapacciuolo A, Arena G, Marini M, Pieragnoli P, Badolati S, Savarese G, Maglia G, Iuliano A, Botto GL, Malacrida M, Bertaglia E. Adherence to 2016 European Society of Cardiology guidelines predicts outcome in a large real-world population of heart failure patients requiring cardiac resynchronization therapy. Heart Rhythm. 2018 Nov;15(11):1675-1682. doi: 10.1016/j.hrthm.2018.04.011. Epub 2018 Apr 14.
• Stabile G, D'Onofrio A, Pepi P, De Simone A, Santamaria M, Caico SI, Rapacciuolo A, Padeletti L, Pecora D, Giovannini T, Arena G, Spotti A, Iuliano A, Bertaglia E, Malacrida M, Botto GL. Interlead anatomic and electrical distance predict outcome in CRT patients. Heart Rhythm. 2015 Nov;12(11):2221-9. doi: 10.1016/j.hrthm.2015.05.020. Epub 2015 May 19.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: April 2, 2012
• First Submitted That Met QC Criteria: April 4, 2012
• First Posted (Estimate): April 6, 2012

Study Record Updates

• Last Update Posted (Actual): February 24, 2017
• Last Update Submitted That Met QC Criteria: February 22, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Heart failure; Cardiac resynchronization therapy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2011/0043537

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No