Responders and Non-responders in the Management of Heart Failure - Significance of Genetic Influence and Identification of Novel Informative Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Identify responders to guideline-directed medical therapy
研究概览
简要总结
A biobank within the Swedish national heart failure quality registry SwedeHF.
详细描述
The national heart failure quality registry SwedeHF started in 2003. It is the world's largest continuous HF registry enrolling clinician-judged HF (regardless of LVEF) at time of hospital or clinical visit. Eighty variables are entered into an electronic database managed by the Uppsala Clinical Research Center (UCR). There are >140,000 registrations from >110,000 unique patients from 70 hospitals in Sweden.
University hospitals in Sweden with access to central biobanking will collect a high-quality biobank linked to SwedeHF consisting of blood plasma, whole blood and urine enabling genetic, proteomic and metabolomic analyses as well as analyses of different biomarkers of interest for HF patients. This will provide unique opportunities for future research within the national SwedeHF registry.
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
- •Written informed consent
- •Heart failure defined by symptoms and signs of heart failure as judged by the local investigator
- •Registered in SwedeHF
排除标准
- •Plasma donation within 1 month of enrolment or any blood donation/blood loss >500 mL during the 3 months prior to enrolment
- •Previous allogeneic bone marrow transplant (genetics)
- •In the opinion of the investigator, condition/s that may either put the patient at risk on participation or influence the results or the patient's ability to participate in the study.
结局指标
主要结局
Identify responders to guideline-directed medical therapy
时间窗: 2 and 5 years
To identify which patient will be a non-responder resulting in a poor outcome, despite being on recommended treatment according to guidelines.
Differences in morbidity between responders and non-responders to guideline-directed medical therapy
时间窗: 2 years
To characterize differences between responders and non-responders in terms of morbidity after 2-years follow-up.
Predictors of responders and non-responders to guideline-directed medical therapy
时间窗: 2 and 5 years
To integrate information regarding clinical characteristics, diagnostic markers and genetics to determine underlying mechanisms behind different responses to treatment.
Differences in mortality between responders and non-responders to guideline-directed medical therapy
时间窗: 2 years
To characterize differences between responders and non-responders in terms of mortality after 2-years follow-up.
次要结局
- Differences between responders and non-responders regarding mortality(2 and 5 years)
- Predictors of morbidity in responders and non-responders(2 and 5 years)
- Differences between responders and non-responders regarding morbidity(2 and 5 years)
- Predictors of mortality in responders and non-responders(2 and 5 years)
研究者
Camilla Hage
Associate Professor
Karolinska University Hospital