Clinical trial NCT01573091: Cardiac Resynchronization Therapy Modular Registry
Official title: Cardiac Resynchronization Therapy Modular Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Cardiac resynchronization therapy
Heart failure
Lead sponsor: University of Florence
Sponsor class: OTHER
First posted: 2012-04-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients eligible for CRT device implanted according to current guidelines

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical response
timeFrame: 24 months
measure: Echocardiographic response of absolute increase of ≥5% in LVEF
timeFrame: 24 months
measure: Echocardiographic response of ≥15% reduction in LVESV
timeFrame: 24 months
Secondary outcomes:
measure: LV lead/RV lead geometric distance
timeFrame: 12 months
measure: Change from baseline in R wave in 12-lead ECG at 12 months
timeFrame: 12 months
measure: Number of ventricular arrhythmias after cardiac resynchronization therapy
timeFrame: 24 months
Other outcomes:
Locations:
city: Biella
country: Italy
facility: Ospedale Degli Infermi
city: Brescia
country: Italy
facility: Cardiovascular Department, Electrophysiology Unit, Istituto Ospedaliero Fondazione Poliambulanza
city: Florence
country: Italy
facility: Department of Heart and Vessels, University of Florence
city: Gallarate
country: Italy
facility: Department of Cardiology and Coronary Care Unit, Azienda Ospedaliera S. Antonio Abate
city: Mantova
country: Italy
facility: Department of Cardio, Thoracic and Vascular, Azienda Ospedaliera Carlo Poma
city: Massa
country: Italy
facility: San Giacomo e Cristoforo
city: Naples
country: Italy
facility: Department of Heart, Electrophysiology, Clinica Mediterranea
city: Napoli
country: Italy
facility: Azienda Ospedale dei Colli - Monaldi
city: Napoli
country: Italy
facility: Policlinico Federico II
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Pesaro
country: Italy
facility: Azienda Ospedaliera San Salvatore
city: Prato
country: Italy
facility: Department of Cardiology, Ospedale Civile "Misericordia e Dolce"
Study officials:
affiliation: Department of Heart and Vessels, University of Florence, Florence, Italy.
name: Luigi Padeletti, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.