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临床试验/NCT04755010
NCT04755010Unknown不适用

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

Hospital Clinico Universitario de Santiago1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
Incidence of AF

研究概览

简要总结

Atrial fibrillation (AF) represents a problem of great implications to patients with heart failure (HF). Therefore, the risk of having AF increases up to 4,5 -5,9 times with the presence of HF. Both conditions share risk factors and the presence of the one worsens the progress of the other. Therefore, the AF is not only relevant in terms of thromboembolic events. Timing of AF progression seems to be associated with an increase in all causes of mortality. Although, it is estimated that between 30%-40% of the patients with HF develop AF, given that in many cases it occurs with no apparent symptoms for the patients, is considered that the number of affected patients is greater. Since silent AF poses a problem of great impact in patients with HF, monitoring through continuous electrocardiographic registry could be useful in those patients with a higher risk of thromboembolic events. The purpose of this study is to understand the mechanism and biological and clinical relevance of the AF from a holistic approach. Trying to distinguish the symptomatic AF from the silent one using the implementation of insertable cardiac devices. The purpose of this study is 1. To determine in which percentage of patients with HF, episodes of AF both symptomatic and asymptomatic occur, as well as if the presence of AF represents an irrelevant fact in the progression of the insufficiency or in the contrary, it is the cause of the HF patients clinical decline. 2. To examine the presence of triggers of AF in patients with HF and to identify the presence of clinical markers, image markers of the atrium and left ventricle, as well as biomarkers which allow the risk of stratification and could mean future therapeutic targets.

详细描述

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:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with the previous diagnosis of HF with both preserved and depressed LVEF. Patients with preserved or intermediate LVEF will be defined according to current guidelines.
  • Patients with signs and symptoms of HFor b) LVEF between 40 and 49 for "mid range" and greater than or equal to 50 for those with LVEF preserved, high natriuretic peptides (BNP> 35 pg / ml and / or NT-proBNP> 125 pg / mL)and at least one of these two criteria: Relevant structural disease (left ventricular hypertrophy or dilatation left earphone).
  • Diastolic dysfunction.

排除标准

  • Previous history of atrial fibrillation.
  • CHA2DS2VASc <
  • Patients requiring ventricular pacing > 40 patients
  • Patients under cardiac resynchronization therapy pacemaker/devices.
  • Patients with severe valvulopathy.
  • Patients with reverseble

结局指标

主要结局

Incidence of AF

时间窗: 3 years

Prevalence and predictor of atrial fibrillation in 300 patients with heart failure and without previous history of AF determined by the Reveal LINQ Insertable Cardiac Monitor

次要结局

  • Echocardiography(3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Moises Rodriguez Mañero

MD,PhD

Hospital Clinico Universitario de Santiago

研究点 (1)

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