Cardiac Resynchronization Therapy Modular Registry

Completed

• Conditions: Heart Failure
• Interventions: Procedure: Cardiac Resynchronization Therapy

• Registration Number: NCT01573091
• Lead Sponsor: Giuseppe Ricciardi

Brief Summary

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

• Study Start: 2011-12
• Study First Submitted: 2012-04-02
• Study First Submitted QC: 2012-04-04
• Study First Posted: 2012-04-06
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Heart failure patients	Cardiac Resynchronization Therapy	Patients with a CRT device according to current guidelines

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of ventricular arrhythmias after cardiac resynchronization therapy	24 months	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
LV lead/RV lead geometric distance	12 months	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.
Change from baseline in R wave in 12-lead ECG at 12 months	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.

Trial Locations

Locations (12)

Department of Heart and Vessels, University of Florence; 🇮🇹 Florence, Italy

San Giacomo e Cristoforo; 🇮🇹 Massa, Italy

Cardiovascular Department, Electrophysiology Unit, Istituto Ospedaliero Fondazione Poliambulanza; 🇮🇹 Brescia, Italy

Azienda Ospedaliera San Salvatore; 🇮🇹 Pesaro, Italy

Department of Cardiology, Ospedale Civile "Misericordia e Dolce"; 🇮🇹 Prato, Italy

Department of Cardio, Thoracic and Vascular, Azienda Ospedaliera Carlo Poma; 🇮🇹 Mantova, Italy

Department of Heart, Electrophysiology, Clinica Mediterranea; 🇮🇹 Naples, Italy

Ospedale Degli Infermi; 🇮🇹 Biella, Italy

Department of Cardiology and Coronary Care Unit, Azienda Ospedaliera S. Antonio Abate; 🇮🇹 Gallarate, Italy

Azienda Ospedale dei Colli - Monaldi; 🇮🇹 Napoli, Italy

Azienda Ospedaliera di Padova; 🇮🇹 Padova, Italy

Policlinico Federico II; 🇮🇹 Napoli, Italy