OPTImal PHARMacological Therapy for Patients With Heart Failure: The OPTIPHARM-HF Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- To describe the prevalence of use of GDMT, both as drugs administered and their dosing, defined according to target guidelines recommended doses, across the full spectrum of EF.
研究概览
简要总结
Prospective, observational, multicenter, national study of adult patients with HF to assess prescription and adherence to evidence-based Guideline-Directed Medical Therapy (GDMT) in patients with Heart Failure (HF).
详细描述
Prospective, observational, multicenter, national study designed to evaluate the care and outcomes of patients with HF, to understand reasons for lack of implementation of evidence-based treatment and the impact of adherence to treatment on clinical outcomes in patients with HF across the full spectrum of left ventricular ejection fraction (LVEF).
The study will enroll consecutive patients with symptomatic HF, aged ≥ 18 years from at least 30 Italian tertiary HF care centers. Both outpatients and in-patients with chronic and acute decompensated HF will be consecutively recruited. Patients will be followed for a maximum duration of 24 months.
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 ≥ 18 years old
- •Signed patient informed consent form (ICF)
- •Diagnosis of chronic or acute decompensated HF according to ESC guidelines and the universal definition of HF.
- •Receiving at least one drug for management of HF at study enrollment (including diuretics, β-blockers, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, aldosterone antagonists).
排除标准
- •Planned participation or participation in a clinical trial;
- •Life expectancy < 1 year because of non-cardiac causes;
- •Previous heart transplant or left ventricular assist device implantation.
结局指标
主要结局
To describe the prevalence of use of GDMT, both as drugs administered and their dosing, defined according to target guidelines recommended doses, across the full spectrum of EF.
时间窗: 1 year
GDMT Prevalence and dosing
次要结局
- To evaluate sequence of introduction of recommended GDMT, medications' up titration, when needed, maintenance of evidence-based treatment during follow-up(1 year)
- To describe GDMT implementation, dosing, and sequencing in specific HF population including de novo HF, worsening HF, advanced HF and HF with improved EF(1 year)
- To assess cumulative rate of CV events and the impact on prognosis of GDMT and its doses.(2 years)
研究者
Marco METRA
Marco Metra
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia