Spanish Multicentric Study of Hyperkalaemia Prevalence, Incidence and Prognosis in Patients With Heart Failure and Reduced Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 565
- 试验地点
- 1
- 主要终点
- One-year incidence of hyperkalemia
研究概览
简要总结
- Participant centres and researchers:
20 National Public Health System hospitals. Cardiology specialist physicians
- Clinical Research Ethics Committee (CREC):
Hospital 12 de Octubre, Madrid
-
Main goal: To estimate prevalence and, in medium term basis (12 months), incidence of hyperkalaemia in heart failure (HF) outpatients with reduced ejection fraction (REF) and its relationship with non-optimal HF therapy and clinical outcomes (mortality and hospital admission).
-
Study design: National multicentric prospective observational study that includes 12 months follow-up of consecutive cases of HF outpatients with REF. Inclusion baseline visit and follow -up visits at 12 months will be scheduled for collecting clinical and blood sample data of patients.
-
Study population: The expected number of patients recruited in 20 Spanish research centres is 600.
详细描述
PARTICIPANT CENTRES AND RESEARCHERS: 20 National Public Health System hospitals. Cardiology specialist physicians
MAIN GOAL: To estimate prevalence and, in medium term basis (12 months), incidence of hyperkalaemia in heart failure (HF) outpatients with reduced ejection fraction (REF) and its relationship with non-optimal HF therapy and clinical outcomes (mortality and hospital admission).
SPECIFIC GOALS:
- -Estimating Hyperkalaemia prevalence in these patients.
- -Assessing the role of hyperkalaemia with the use of non-optimal therapy doses.
- -Estimating 12 months hyperkalaemia incidence on these patients and describing the severity of the episodes.
- -Estimating incidence of HF hospital admission and/or death in these patients on a medium term basis (12 months) and its association with existence of hyperkalaemia during follow up.
- -Assessing hyperkalaemia risk during follow-up in relation with the existence of diabetes and/or renal failure (RF) at baseline visit.
STUDY DESIGN National multicentric prospective observational study that includes 12 months follow-up of consecutive cases of HF outpatients with REF. Inclusion baseline visit and follow -up visit at 12 months will be scheduled for collecting clinical and blood sample data of patients.
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
- •Patients, women or men, aged 18 or more
- •Documented HF with REF (<40%) diagnosis
- •Signed written informed consent
排除标准
- •Any type of disorder affecting the capacity to give free and informed written consent
- •Clinical trial enrolment at the moment of the inclusion
- •Patients suffering stage 5 chronic kidney disease
- •Patients with less than a year life span due to diseases different from HF
- •Not having completed HF drug titration stage at the moment of inclusion (this stage is not completed if, on doctor's judgement, possible maximum doses have not been reached in RAA system drugs and any of these drugs has been included or dose-modified in recruitment visit)
- •Informed consent refusal
- •At any time during follow-up patients can leave the study (and will be censored in the analysis) or retire their consent (and will be excluded from the analysis).
结局指标
主要结局
One-year incidence of hyperkalemia
时间窗: 12 months
New onset of serum K+ \>5,4 mEq/L
次要结局
- One-year incidence of heart failure hospital admission and/or mortality(12 months)
- One-year incidence of heart failure hospital admission(12 months)
- Non-optimal heart failure therapy(12 months)
- One-year incidence of mortality(12 months)
研究者
Maria G. Crespo Leiro
Principal Investigator
Spanish Society of Cardiology