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NCT Number: NCT06675552

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

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.

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Key information

Conditions

Heart Disease Cardiovascular Disease Cardiovascular Diseases Heart Diseases Heart Failure Heart Failure, Systolic

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Berlin, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Proportion of patients treated with HFrEF GDMT

    Time frame: 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

Secondary outcomes

  1. Number of recommended HF-drug classes

    Time frame: Baseline to hospital discharge, on average 6 days after hospitalization/baseline

    The HF-drug classes including the corresponding doses that are recommended in discharge letter at hospital discharge

  2. Change of percentage in HFrEF GDMT

    Time frame: Baseline to 12 months

    The percentage of patients who are newly initiated on guideline-directed HFrEF medical therapy

  3. Change of phenotype-concordant guideline-recommended HF drug classes

    Time frame: Hospital Discharge (on average 6 days after hospitalization/baseline) to 12 months

    The number of patients with change in phenotype-concordant guideline- recommended HF drug classes

  4. Reasons for GDMT adjustments

    Time frame: Hospital Discharge (on average 6 days after hospitalization/baseline) to 12 months

    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

  5. Reasons for not having guideline-recommended drug classes or doses

    Time frame: Hospital Discharge (on average 6 days after hospitalization/baseline) to 12 months

    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

  6. Number of outpatient post-discharge visits

    Time frame: Hospital Discharge (on average 6 days after hospitalization/baseline) to 3 months

    The number of outpatient visits for heart failure treatment within the first three months after hospital discharge

  7. Proportion of patients conducting post-discharge visits

    Time frame: Hospital Discharge (on average 6 days after hospitalization/baseline) to 3 months

    Proportion of patients conducting post-discharge visits for heart failure treatment within the first three months after hospital discharge

  8. Absolute change from baseline in NYHA class

    Time frame: Measured at 6 and 12 months

    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.

  9. Change from Baseline in blood pressure

    Time frame: Baseline to 12 months

    Changes in patients blood pressure as noted in patients electronic medical records /

  10. Change from Baseline in heart rate

    Time frame: Baseline to 12 months

    Changes in patients heart rate as noted in patients electronic medical records

  11. Change from Baseline in electrolyte level

    Time frame: Baseline to 12 months

    Changes in patients electrolyte level as noted in patients electronic medical records

  12. Change from Baseline in potassium level

    Time frame: Baseline to 12 months

    Changes in patients potassium level as noted in patients electronic medical records

  13. Change from Baseline in estimated glomerular filtrations rate

    Time frame: Baseline to 12 months

    Changes in patients estimated glomerular filtration rate as noted in patients electronic medical records

  14. Change from Baseline in serum creatinine concentration

    Time frame: Baseline to 12 months

    Changes in patients serum creatinine concentration as noted in patients electronic medical records

  15. Number of rehospitalization for heart failure

    Time frame: Hospital Discharge (on average 6 days after hospitalization/baseline) to 12 months

    The number of patients being rehospitalized for heart failure within the observational period

  16. Overall Survival

    Time frame: Baseline to 12 months

    Number of patients who died during the observational period

  17. CV-specific survival

    Time frame: Baseline to 12 months

    Number of patients who died due to cardiovascular disease during observation period

  18. Absolute change from baseline in Medication Adherence Report Scale (MARS)-5 questionnaire

    Time frame: Measured at 6 and 12 months

    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.

  19. Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) score

    Time frame: Measured at 6 and 12 months

    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

  20. Absolute change from baseline in PROMIS Global Health 10

    Time frame: Measured at 6 and 12 months

    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.

  21. Absolute change from baseline in the Nine-Item Patient Health Questionnaire (PHQ-9)

    Time frame: Measured at 6 and 12 months

    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.

  22. Number of diuretics changes

    Time frame: Baseline to 12 months

    The number of patients who experience a switch in their diuretic medication drug class as noted in patients electronic medical record

  23. Number of concomitant medication changes

    Time frame: Baseline to 12 months

    The number of patients who experience a switch in their concomitant medication drug class as noted in patients electronic medical record

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: PHRASE-HF

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 5, 2024
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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