Cardiovascular Risk, Myocardial Fibrosis and Heart Failure in Rheumatoid Arthritis: Screening and Prognosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 主要终点
- Number of Participants with New diagnosis of heart failure
研究概览
简要总结
Cardiovascular disease is the leading cause of death in RA patients. This increased risk may be apparent even before the clinical recognition of RA. The optimal approach for identification of patients with increased CV risk has yet to be fully established and a substantial proportion of RA patients at high risk remain unidentified.
Heart failure (HF) has been recently recognized as an important contributory factor to the excess CV mortality associated with RA (more than myocardial ischemia), and RA patients with concomitant HF have twice the risk of CV death compared with patients with RA alone. HF in RA typically presents with occult or atypical clinical symptomatology, tend to be managed less aggressively and have poorer outcomes.
For developing effective preventive strategies, the evaluation of patients in early asymptomatic stages is of great importance.
The investigators propose to perform an observational longitudinal study (with cases and controls) including RA patients (with and without HF) from a single centre to determine cardiovascular profiles that may be associated with higher risk for developing symptomatic HF and CV events. For this purpose the investigators will use clinical, echocardiographic, serum biomarker, and genetic data
详细描述
Patient Selection:
Screen ~400 Rheumatoid Arthritis (RA) patients followed in Centro Hospitalar do Porto outpatient clinic. All RA patients with regular follow-up will be potentially included.
The investigators also aim to enrol age-matched controls for biomarker comparison.
Experimental Design:
Observacional study with matched control. No intervention will be performed. Outpatients fulfilling the inclusion criteria will be invited to participate in the study. All patients will have to sign written informed consent to participate in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Rheumatoid arthritis
- •Regular follow up on Autoimmune diseases medical appointment
- •Written informed consent to participate in this study prior to any study procedures
排除标准
- •Presence of severe life-threatening disease before inclusion with an expected survival of less than 6 months after inclusion
- •Mental or physical status not allowing written informed consent
- •Active malignancy disease
- •Patient unable to walk, in which SMWT is not possible to perform.
结局指标
主要结局
Number of Participants with New diagnosis of heart failure
时间窗: 11 to 32 months
New onset of heart failure symptons with diuretic drugs starting
Number of dead participants
时间窗: 11 to 32 months
Death of any cause
次要结局
- Number of Participants with new onset atrial fibrillation(11 to 32 months)
- Number of Participants with Hospitalization(11 to 32 months)
- Number of Participants with worsening of previous heart failure(11 to 32 months)
- Number of Participants with new onset of stroke or Transient ischemic attack(11 to 32 months)
- Number of Participants with New onset of acute myocardial infarction(11-32 months)
研究者
Maria Betânia Almeida Dias Ferreira
Internal Medicine Medical Doctor, PhD student
Centro Hospitalar do Porto