Non-interventional Study on Guideline Directed Medical Therapy for Patients With Heart Failure (HF) in Germany

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Proportion of patients treated with HFrEF GDMT [Срок оценки: Baseline to hospital discharge, on average 6 days after hospitalization/baseline]

Вторичные конечные точки (12)

• Number of recommended HF-drug classes [Срок оценки: Baseline to hospital discharge, on average 6 days after hospitalization/baseline]
• Change of percentage in HFrEF GDMT [Срок оценки: Baseline to 12 months]
• Change of phenotype-concordant guideline-recommended HF drug classes [Срок оценки: Hospital Discharge (on average 6 days after hospitalization/baseline) to 12 months]
• Reasons for GDMT adjustments [Срок оценки: Hospital Discharge (on average 6 days after hospitalization/baseline) to 12 months]
• Reasons for not having guideline-recommended drug classes or doses [Срок оценки: Hospital Discharge (on average 6 days after hospitalization/baseline) to 12 months]
• Number of outpatient post-discharge visits [Срок оценки: Hospital Discharge (on average 6 days after hospitalization/baseline) to 3 months]
• Proportion of patients conducting post-discharge visits [Срок оценки: Hospital Discharge (on average 6 days after hospitalization/baseline) to 3 months]
• Absolute change from baseline in NYHA class [Срок оценки: Measured at 6 and 12 months]
• Change from Baseline in blood pressure [Срок оценки: Baseline to 12 months]
• Change from Baseline in heart rate [Срок оценки: Baseline to 12 months]
• Change from Baseline in electrolyte level [Срок оценки: Baseline to 12 months]
• Change from Baseline in potassium level [Срок оценки: Baseline to 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 6 центров

• Research Site — Berlin
• Research Site — Erfurt
• Research Site — Gifhorn
• Research Site — Leipzig
• Research Site — Schwerin
• Research Site — Wuppertal

Идентификаторы

NCT: NCT06675552 · D1699R00045

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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