Guideline Implementation and Quality of Care Evaluation in Patients With Heart Failure and Reduced Ejection Fraction (HFrEF): The IMPLEMENT-HF Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,500
- 主要终点
- The prescription level (%) of GDMT / 4 pillars in de novo HFrEF patients.
研究概览
简要总结
The IMPLEMENT HF study is part of the national heart failure quality of care registry (evaluation of given health care). Within the HF registry, the investigators will investigate whether mirror information on the actual 4 pillars of guideline directed medical therapy (GDMT) in HFrEF patients will help to further improve the implementation of GDMT.
Data will be used from the national HF registry in the Netherlands. Two groups will be studied, one where the HCP receives the mirror information on GDMT and one where both the patient and the HCP receive the mirror information on GDMT. GDMT or the 4 pillars treatment is standard of care as recommended by the ESC HF guidelines, indicated for all HFrEF patients. The project is a quality of care registry and health care evaluation to optimize adherence to the HF guidelines.
详细描述
The IMPLEMENT HF is a sequel study to the TITRATE HF study that has shown that the level of GDMT prescription in de novo HFrEF can be further improved. The investigators hypothesize that mirror information about actual levels of GDMT helps the physician and patient optimize GDMT as recommended in the guideline. The IMPLEMENT is a registry based study in 1500 with de novo HFrEF patients, in which mirror information on GDMT (4 pillars) prescription levels will be shown to the treating physician. In a second group (50%) both the physician and patient will receive the mirror information on the prescription of GDMT. For diversity, the investigators aim to include 50% elderly and 50% women in to the registry. The primary endpoint is the prescription level of GDMT. Secondary endpoints are the dosing levels of GDMT (% target dose) and incident clinical events.
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
- •Age ≥18 years
- •Diagnosis of HFrEF according to ESC HF guidelines (EF <40%)
- •Participant is willing to participate for 1 years of follow-up for standard of care at the outpatient clinic of the participating hospital and the local investigator follows the patients for the time frame of 1 years on reported endpoints.
排除标准
- •An expected life expectancy less than 1 year due to other comorbidities according to the treating physician
- •A major CV event (e.g. disabling stroke, myocardial infarction, open heart surgery) within 3 months of enrollment, if likely to interfere with GDMT titration or regular follow-up.
- •Advanced or Endstage Heart Failure stage in which advanced HF treatment with an LVAD or heart transplant is anticipated within 6 months after the baseline visit.
- •At enrollment the patient has heart failure with reduction ejection fraction with an established EF below 40%.
研究组 & 干预措施
Guideline recommended drug therapy for HFrEF with mirror information to HCP
Guideline recommended drug therapy for HFrEF with mirror information to HCP
Guideline recommended drug therapy for HFrEF with mirror information to HCP and patient
Guideline recommended drug therapy for HFrEF with mirror information to HCP and patient.
结局指标
主要结局
The prescription level (%) of GDMT / 4 pillars in de novo HFrEF patients.
时间窗: 1 year of follow-up
The prescription level (%) of GDMT / 4 pillars in patients with de novo HFrEF at specific time moments durign 1 year (6 weeks, 3 Months , 6 Months, 12 Months)
次要结局
- The % of target dose of GDMT prescribed in de novo HFrEF patients(1 year (evaluated at time moments 6 weeks, 3 Months, 6 Months, 12 Months).)
- Incident events(1 year of follow-up (12 months))
研究者
Jasper Brugts MD PhD
Lead investigator of the CRO/Sponsor Erasmus MC, Department of Cardiology, Dr. Molewaterplein 40, Rotterdam, The Netherlands
Erasmus Medical Center