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.
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.
Study Type
OBSERVATIONAL
Enrollment
438
Research Site
Berlin, Germany
RECRUITINGResearch Site
Erfurt, Germany
RECRUITINGResearch Site
Gifhorn, Germany
RECRUITINGResearch Site
Leipzig, Germany
RECRUITINGResearch Site
Schwerin, Germany
RECRUITINGResearch Site
Wuppertal, Germany
RECRUITINGProportion of patients treated with HFrEF GDMT
Proportion of patients treated with phenotype-concordant guideline-recommended HF drug classes and the corresponding doses as noted in patients electronic medical records
Time frame: Baseline to hospital discharge, on average 6 days after hospitalization/baseline
Number of recommended HF-drug classes
The HF-drug classes including the corresponding doses that are recommended in discharge letter at hospital discharge
Time frame: Baseline to hospital discharge, on average 6 days after hospitalization/baseline
Change of percentage in HFrEF GDMT
The percentage of patients who are newly initiated on guideline-directed HFrEF medical therapy
Time frame: Baseline to 12 months
Change of phenotype-concordant guideline-recommended HF drug classes
The number of patients with change in phenotype-concordant guideline- recommended HF drug classes
Time frame: Hospital Discharge (on average 6 days after hospitalization/baseline) to 12 months
Reasons for GDMT adjustments
The reasons for guideline-directed medical therapy changes as noted in patients electronic medical records will be described as the number and proportion of patients who experienced adjustment in guideline-directed medical therapy according to each reasons presented
Time frame: Hospital Discharge (on average 6 days after hospitalization/baseline) to 12 months
Reasons for not having guideline-recommended drug classes or doses
The reasons for not having maximal phenotype-concordant guideline-recommended HF drug classes as noted in patients electronic medical records will be described as the number and proportion of patients who are not having maximal GDMT drug classes according to each reasons presented
Time frame: Hospital Discharge (on average 6 days after hospitalization/baseline) to 12 months
Number of outpatient post-discharge visits
The number of outpatient visits for heart failure treatment within the first three months after hospital discharge
Time frame: Hospital Discharge (on average 6 days after hospitalization/baseline) to 3 months
Proportion of patients conducting post-discharge visits
Proportion of patients conducting post-discharge visits for heart failure treatment within the first three months after hospital discharge
Time frame: Hospital Discharge (on average 6 days after hospitalization/baseline) to 3 months
Absolute change from baseline in NYHA class
The NYHA classification is a regimen for the classification of heart failure into certain stages according to clearly defined criteria. Treatment of heart failure is usually based on the NYHA classification. Symptoms used to evaluate the stages include dyspnea, nocturia at night, cyanosis, general weakness and fatigue, angina pectoris or cold extremities, edema. NYHA-I: No limitation on resilience. Complete absence of symptoms or signs of exertion when heart disease is diagnosed; NYHA-II: Slight decrease in endurance. Freedom from discomfort during rest and with mild exertion, occurrence of symptoms with increased stress; NYHA-III: Severe limitation of resilience. Freedom from discomfort at rest, occurrence of symptoms even with mild exertion; NYHA-IV: Permanent symptoms, even during rest.
Time frame: Measured at 6 and 12 months
Change from Baseline in blood pressure
Changes in patients blood pressure as noted in patients electronic medical records /
Time frame: Baseline to 12 months
Change from Baseline in heart rate
Changes in patients heart rate as noted in patients electronic medical records
Time frame: Baseline to 12 months
Change from Baseline in electrolyte level
Changes in patients electrolyte level as noted in patients electronic medical records
Time frame: Baseline to 12 months
Change from Baseline in potassium level
Changes in patients potassium level as noted in patients electronic medical records
Time frame: Baseline to 12 months
Change from Baseline in estimated glomerular filtrations rate
Changes in patients estimated glomerular filtration rate as noted in patients electronic medical records
Time frame: Baseline to 12 months
Change from Baseline in serum creatinine concentration
Changes in patients serum creatinine concentration as noted in patients electronic medical records
Time frame: Baseline to 12 months
Number of rehospitalization for heart failure
The number of patients being rehospitalized for heart failure within the observational period
Time frame: Hospital Discharge (on average 6 days after hospitalization/baseline) to 12 months
Overall Survival
Number of patients who died during the observational period
Time frame: Baseline to 12 months
CV-specific survival
Number of patients who died due to cardiovascular disease during observation period
Time frame: Baseline to 12 months
Absolute change from baseline in Medication Adherence Report Scale (MARS)-5 questionnaire
The MARS-5 is five-item self-report adherence scale which assesses both intentional and non-intentional non-adherence. Respondents rate the frequency with which the five different medication-taking behaviours occur, scoring each item on a 1-5-point scale with higher scores indicating higher reported adherence. The MARS-5 has been shown to be reliable and valid across a variety of health conditions, including cardiovascular and pulmonary diseases. Only applicable to Prospective cohort.
Time frame: Measured at 6 and 12 months
Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
The KCCQ is a 23-item questionnaire that quantifies physical limitations, self-efficacy, social interference and quality of life. Summary scores will be examined at each assessment point during follow-up. For each of the assessment periods, descriptive statistics for the observed value, change from baseline and the 95% two-sided confidence interval for the mean change will be presented. The proportions of participants with overall health status classified as poor, fair, good, and excellent will be examined at each assessment point. Additionally, the proportions of participants who experience clinically meaningful changes in overall health status: improvement (≥5 point increase), deterioration (≥5 point decrease), and stable (\<5 point increase or decrease) will be examined at each assessment point. Only applicable to Prospective cohort
Time frame: Measured at 6 and 12 months
Absolute change from baseline in PROMIS Global Health 10
The PROMIS 10 is a validated comprehensive and accessible set of tools used to measure self-reported physical, mental and social health; including symptoms, function and general perceptions of health and wellbeing. The PROMIS 10 consists of ten items that measure physical health, physical functioning, general mental health, emotional distress, satisfaction with social activities and relationships, ability to carry out usual social activities and roles, pain, fatigue and overall quality of life.
Time frame: Measured at 6 and 12 months
Absolute change from baseline in the Nine-Item Patient Health Questionnaire (PHQ-9)
HF is associated with depressive disorders and manifest depressions. The PHQ-9 that capture depressed mood and anhedonia has been validated as an ultra-brief screening tool with some evidence of responsiveness. The PHQ-9 score is obtained by adding the score for each question (total points). A PHQ-9 score ranges from 0-27, to determine whether they meet criteria for a depressive disorder.
Time frame: Measured at 6 and 12 months
Number of diuretics changes
The number of patients who experience a switch in their diuretic medication drug class as noted in patients electronic medical record
Time frame: Baseline to 12 months
Number of concomitant medication changes
The number of patients who experience a switch in their concomitant medication drug class as noted in patients electronic medical record
Time frame: Baseline to 12 months
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