PHenotype-based RApid SEquencing of Guideline-directed Medical Therapy for Heart Failure With Reduced Ejection Fraction (PHRASE-HF): A Multicentre, Prospective, Non-interventional Study to Examine Outcomes of Rapid In-hospital Implementation of GDMT and Its Translation From Discharge Into Routine Care
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Heart Disease
- 发起方
- AstraZeneca
- 入组人数
- 438
- 试验地点
- 7
- 主要终点
- Proportion of patients treated with HFrEF GDMT
- 状态
- 招募中
- 最后更新
- 2个月前
概览
简要总结
Heart failure (HF) is a global public health issue that affects more than 63 million people worldwide. The clinical and economic burden of HF on health care systems is substantial. Heart failure with reduced ejection fraction (HFrEF) represents approximately 50% of the HF patient population.The burden of HF is expected to increase substantially as the population ages, and despite improvements in treatment, hospitalisation and mortality rates remain especially high in HFrEF patients. The current guideline recommendation of directed medical therapy for HFrEF combines four drug classes with proven prognostic benefit: Angiotensin receptor-neprilysin inhibitor (ARNI)/angiotensin converting enzyme inhibitors (ACE I)/angiotensin receptor blockers (ARB), betablockers (BB), mineralocorticoid receptor antagonists (MRA), and sodium-glucose co-transporter 2 inhibitors (SGLT2i). The 2023 ESC (European Society of Cardiology) HF guideline update additionally recommends a rapid in-hospital sequencing approach of guideline-directed medical therapy (GDMT) with frequent physician visits during the first 6 weeks post discharge. Studies investigating the implementation of GDMT in a real-world setting have shown that a significant proportion of patients did not receive the recommended drug combination therapy. Delayed initiation of GDMT contributes to the low number of patients receiving guideline concordant HFrEF therapy, which ultimately may affect patient outcomes. One approach to implement the 2023 ESC guideline updates for heart failure treatment regarding early in-hospital initiation and rapid up-titration of GDMT could be to provide specific training on GDMT recommendations. Such a standardised training is offered to the physicians treating HF patients within selected hospitals of the German Helios hospital network (Helios-GDMT-program). Evidence is needed in order to assess whether in-hospital initiation and up-titration of all phenotype concordant classes of GDMT at hospital discharge can be observed after standardised physician training and whether the GDMT-program implementation also translates into real-world routine outpatient care with respect to use of GDMT and clinical outcomes.
详细描述
The overall aim of PHRASE-HF is to evaluate the use of GDMT at hospital discharge, the translation of in-hospital implementation and possible maximisation of phenotype-based GDMT into real-world routine outpatient care, HF symptoms, patient reported outcomes (PROs), clinically relevant outcomes (e.g. rehospitalisation, mortality), use of diuretics and concomitant drug classes in patients admitted for in-hospital treatment of HFrEF to sites trained within the Helios-GDMT-program. The analyses will primarily be done in a total study population, and as defined by exploratory objectives in subgroups of interest.
研究者
入排标准
入选标准
- •Age ≥18 years at the time of signing the informed consent
- •Hospitalised in a participating site and receiving full inpatient treatment (at least 24h hospital stay)
- •Diagnosis of HFrEF according to the current guidelines of the European Society of Cardiology (ESC) with a left ventricular EF of ≤40% (as measured per echocardiography during the index hospital stay or within 3 months prior to index hospitalisation with available reports from imaging (ejection fraction) at the time of study inclusion)
- •Treated with a maximum of 2 of the indicated drug classes (ACE-I/ARNI/ARB, BB, MRA, SGLT2i) according to guideline recommendation (GDMT) at admission.
- •Signed and dated written informed consent prior to enrolment in the study
- •Willing and capable to fulfil requirements listed in the ICF
排除标准
- •Initial presentation (index hospitalisation) in cardiogenic shock or other kinds of shock
- •Status post heart transplantation
- •History of intolerance to one or more GDMT drug classes (ACE-I/ARNI/ARB, BB, MRA, SGLT2i) or significant side effects that led to the discontinuation of two or more substances within one drug class (except from ACE-I/ARB, e.g., if 2 different ACE inhibitors triggered cough, but sartans are tolerated, then the patient is not excluded)
- •Current or planned participation in a clinical trial
- •Decision by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures
- •Pregnancy or breast-feeding
结局指标
主要结局
Proportion of patients treated with HFrEF GDMT
时间窗: Baseline to hospital discharge, on average 6 days after hospitalization/baseline
Proportion of patients treated with phenotype-concordant guideline-recommended HF drug classes and the corresponding doses as noted in patients electronic medical records
次要结局
- Number of recommended HF-drug classes(Baseline to hospital discharge, on average 6 days after hospitalization/baseline)
- Change of percentage in HFrEF GDMT(Baseline to 12 months)
- Change of phenotype-concordant guideline-recommended HF drug classes(Hospital Discharge (on average 6 days after hospitalization/baseline) to 12 months)
- Reasons for GDMT adjustments(Hospital Discharge (on average 6 days after hospitalization/baseline) to 12 months)
- Reasons for not having guideline-recommended drug classes or doses(Hospital Discharge (on average 6 days after hospitalization/baseline) to 12 months)
- Number of outpatient post-discharge visits(Hospital Discharge (on average 6 days after hospitalization/baseline) to 3 months)
- Proportion of patients conducting post-discharge visits(Hospital Discharge (on average 6 days after hospitalization/baseline) to 3 months)
- Absolute change from baseline in NYHA class(Measured at 6 and 12 months)
- Change from Baseline in blood pressure(Baseline to 12 months)
- Change from Baseline in heart rate(Baseline to 12 months)
- Change from Baseline in electrolyte level(Baseline to 12 months)
- Change from Baseline in potassium level(Baseline to 12 months)
- Change from Baseline in estimated glomerular filtrations rate(Baseline to 12 months)
- Change from Baseline in serum creatinine concentration(Baseline to 12 months)
- Number of rehospitalization for heart failure(Hospital Discharge (on average 6 days after hospitalization/baseline) to 12 months)
- Overall Survival(Baseline to 12 months)
- CV-specific survival(Baseline to 12 months)
- Absolute change from baseline in Medication Adherence Report Scale (MARS)-5 questionnaire(Measured at 6 and 12 months)
- Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) score(Measured at 6 and 12 months)
- Absolute change from baseline in PROMIS Global Health 10(Measured at 6 and 12 months)
- Absolute change from baseline in the Nine-Item Patient Health Questionnaire (PHQ-9)(Measured at 6 and 12 months)
- Number of diuretics changes(Baseline to 12 months)
- Number of concomitant medication changes(Baseline to 12 months)