NCT01091467已完成不适用
Prospective Study of Heart Failure With Preserved Left Ventricular Ejection Fraction: Prevalence, Characterisation and Prognostic Significance of Cardiac Desynchrony
French Cardiology Society2 个研究点 分布在 2 个国家目标入组 362 人开始时间: 2008年10月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 362
- 试验地点
- 2
- 主要终点
- Death rate
研究概览
简要总结
The purpose of this study is to examine electrical and echocardiographic characteristics and prognosis of consecutive patients admitted with acute heart failure and diagnosed to have heart failure with preserved ejection fraction (HFPEF).
详细描述
- Time 0: Patients will be screened at the time of presentation to the hospital at participating centres
- Usually patients will be hospitalised for an acute dyspnea in relation with a pulmonary congestion. This congestion does not necessarily justify a hospitalization and for part of the patients a consultation and a dedicated treatment would be good enough to cure the symptoms.
- Thus, patients seen in emergency for a congestion and diagnosed or known to have a preserved left ventricular ejection fraction (LV EF > 45%) will be proposed to participate to the study.
- Patients meeting inclusion criteria will be invited back to the clinic in stable condition, approximately 4-8 weeks after the initial hospitalization.
- Time 4-8 weeks after initial hospitalisation (NOT after discharge): Comprehensive history-taking and examinations.
- Any information necessary for the study will be collected by the principal investigator in each participating center in a dedicated, secure, e-CRF. The access to the e-CRF will be restrictive to the only principal investigator of each center. The lonely other persons able to take look to the e-CRF are the study monitors.
- Time 6, 12, and 18 months: Follow up by phone call or review of charts or other records such as death registries. This part of the study will be performed by the CRAs in the French Society of Cardiology
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
- 否
入选标准
- •Patient presenting to the hospital with congestive heart failure, defined as:
- •Clinical signs of heart failure
- •Major criteria
- •Paroxysmal nocturnal dyspnea
- •Orthopnea
- •Jugular venous distension
- •Pulmonary crackling rales
- •3rd heart sound
- •Cardiothoracic ratio > 0.5 on X-ray
- •Pulmonary oedema on X-ray
- •Minor Criteria
- •peripheral oedema
- •nocturnal cough
- •dyspnoea at exercise
- •hepatomegaly
- •pleural effusion
- •tachycardia (defined as ≥ 100 beats per minute)
- •Heart failure if: presence of 2 major criteria or 1 major + 2 minor criteria
- •LVEF ≥ 45% by echocardiography within 72h
- •BNP > 100 ng/L or NT-proBNP > 300 ng/L
排除标准
- •Evidence of primary hypertrophic or restrictive cardiomyopathy or systemic illness known to be associated with infiltrative heart disease
- •Known cause of right heart failure not related to left ventricular dysfunction
- •Pericardial constriction
- •Clinically significant pulmonary disease, as evidenced by requirement of home oxygen.
- •End-stage renal disease requiring dialysis
- •Bi-ventricular pacemaker (CRT)
结局指标
主要结局
Death rate
时间窗: 18 months
Analyse survival (all-cause death)
次要结局
- Cardiovascular death(18 months)
- Hospitalization for HF(18 months)
研究者
Donal Erwan
Assistant Professor
French Cardiology Society
研究点 (2)
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