Cardiac Resynchronization Therapy Modular Registry

Heart Failure Clinical Trial

— CRT-MORE  

Official title:

Cardiac Resynchronization Therapy Modular Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01573091
• Other study ID #: 2011/0043537
• Status: Completed
• Phase: N/A
• First received: April 2, 2012
• Last updated: February 22, 2017
• Start date: December 2011
• Est. completion date: December 2015

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Italy	Ospedale Degli Infermi	Biella
Italy	Cardiovascular Department, Electrophysiology Unit, Istituto Ospedaliero Fondazione Poliambulanza	Brescia
Italy	Department of Heart and Vessels, University of Florence	Florence
Italy	Department of Cardiology and Coronary Care Unit, Azienda Ospedaliera S. Antonio Abate	Gallarate
Italy	Department of Cardio, Thoracic and Vascular, Azienda Ospedaliera Carlo Poma	Mantova
Italy	San Giacomo e Cristoforo	Massa
Italy	Department of Heart, Electrophysiology, Clinica Mediterranea	Naples
Italy	Azienda Ospedale dei Colli - Monaldi	Napoli
Italy	Policlinico Federico II	Napoli
Italy	Azienda Ospedaliera di Padova	Padova
Italy	Azienda Ospedaliera San Salvatore	Pesaro
Italy	Department of Cardiology, Ospedale Civile "Misericordia e Dolce"	Prato

Sponsors (1)

Lead Sponsor	Collaborator
Giuseppe Ricciardi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response	Improvement in functional class status by at least one NYHA Class or remain in functional class II	24 months
Primary	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
Primary	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	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
Secondary	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
Secondary	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