"De Novo" Atrial Fibrillation in Patients With Heart Failure: Incidence; Predictors and Relevance.

Summary

Participation Requirements

Description

Multicenter prospective study formed by units with experience in the management of patients with HF (Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain; Hospital Clínico Universitario de Salamanca, Salamanca, Spain and Hospital Universitario Virgen de la Arrixaca...

Multicenter prospective study formed by units with experience in the management of patients with HF (Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain; Hospital Clínico Universitario de Salamanca, Salamanca, Spain and Hospital Universitario Virgen de la Arrixaca, Murcia, Spain). Based on an AF development estimate of 30%, it has been estimated a minimum follow-up of 18 months and a maximum of 36 months for obtaining robust conclusions. On the basis of previously reported data, it has been estimated that the annual rate of AF in patients 65 years of age or older who have CHA2DS2VASc ? 2 and who have received an ICM is 6%. The enrolment of 300 patients had been estimated. The study would have 95% power to detect an episode of rapid atrial rate. Those patients with a CHA2DS2VASc ?2 seen in the HF unit will be prospectively included. In these patients, the previous diagnosis of AF will be assessed by means of clinical history and medical records. Patients with previous AF will be excluded. Patients with preserved or intermediate LVEF will be defined according to current guidelines. Patients with signs and symptoms of HF. LVEF between 40 and 49 for "mid-range" and greater than or equal to 50 for those with LVEF preserved and at least one of these two criteria: High natriuretic peptides (BNP> 35 pg / ml and / or NT-proBNP> 125 pg / mL) Relevant structural disease (left ventricular hypertrophy or dilatation left earphone). Diastolic dysfunction. The data will be collected individually by each recruiting center and introduced in the online registration form that will be enabled (see next point). The definition of variables will be agreed upon among all recruiting centers. The information collected will be dumped into a database created specifically for this purpose and will be coordinated from the Hospital Clínico de Santiago de Compostela. Remote monitoring The CareLink remote monitoring system allows remote monitoring of patients, without the need to go to the hospital center. This system establishes a connection between the patient and the medical center, through the patient monitor that reads the information from the implanted device and transmits it to a secure server. This communication allows the transmission of clinically significant events or, in the case of wireless devices, the sending of alerts. In this way, the healthcare professional has information of the event and allows him to anticipate the evaluation and treatment with the consequent benefit for the patient. Biological characterization Human plasma samples: Total venous blood samples (10 ml) will be collected in EDTA tubes as anticoagulants and separated by centrifugation at 1500xg during 15 minutes plasma and cellular fractions. The supernatant and the cell pellet are transferred to tubes and stored at -80°C. The serological samples will be stored in each center of origin. Several determinations will be performed:

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