Heart DiseasePHRASE-HFNCT06675552
Non-interventional Study on Guideline Directed Medical Therapy for Patients With Heart Failure (HF) in Germany
An observational study of Heart Disease and Heart Failure, run by AstraZeneca at 6 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Heart Disease, Heart Failure, Cardiovascular Disease
- How many people
- 338 participants
- Where
- 6 sitesGermany
- Study dates
- 15 Nov 2024to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 438 patients with reduced ejection fraction (HFrEF) admitted for in-hospital treatment with a maximum of 2 of the indicated guideline recommended drug classes (ACE-I/ARNI/ARB, BB, MRA, SGLT2i) in the current medication plan are planned to be enrolled consecutively. Recruitment will take place at 5-7 inpatient cardiology departments at Helios hospitals trained by Helios-GDMT-Program throughout Germany.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Research Site
Berlin, 13125
Research Site
Erfurt, 99089
Research Site
Gifhorn, 38518
Research Site
Leipzig, 04289
Research Site
Schwerin, 19049
Research Site
Wuppertal, 42117
About this study
Official 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
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.
Read the detailed description
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.
- Keywords
- Heart Failure with Reduced Ejection Fraction (HFrEF), Guideline Directed Medical Therapy, Real-World Evidence
- Medical subject headings
- Heart Diseases, Heart Failure, Cardiovascular Diseases, Heart Failure, Systolic
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion 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
Measured: Baseline to hospital discharge, on average 6 days after hospitalization/baseline
Secondary outcomes (23)
Number of recommended HF-drug classes
The HF-drug classes including the corresponding doses that are recommended in discharge letter at hospital discharge
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Measured at 6 and 12 months
Change from Baseline in blood pressure
Changes in patients blood pressure as noted in patients electronic medical records /
Measured: Baseline to 12 months
Change from Baseline in heart rate
Changes in patients heart rate as noted in patients electronic medical records
Measured: Baseline to 12 months
Change from Baseline in electrolyte level
Changes in patients electrolyte level as noted in patients electronic medical records
Measured: Baseline to 12 months
Change from Baseline in potassium level
Changes in patients potassium level as noted in patients electronic medical records
Measured: 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
Measured: Baseline to 12 months
Change from Baseline in serum creatinine concentration
Changes in patients serum creatinine concentration as noted in patients electronic medical records
Measured: Baseline to 12 months
Number of rehospitalization for heart failure
The number of patients being rehospitalized for heart failure within the observational period
Measured: Hospital Discharge (on average 6 days after hospitalization/baseline) to 12 months
Overall Survival
Number of patients who died during the observational period
Measured: Baseline to 12 months
CV-specific survival
Number of patients who died due to cardiovascular disease during observation period
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start15 Nov 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675552
- Sponsor's protocol ID
- D1699R00045
- Acronym
- PHRASE-HF
- Status last verified
- Aug 2026
- First submitted
- 20 Sep 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06675552
- Acronym / sponsor ID
- PHRASE-HF / D1699R00045
- Keywords
- Heart Failure with Reduced Ejection Fraction (HFrEF), Guideline Directed Medical Therapy, Real-World Evidence
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 338 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 438 patients with reduced ejection fraction (HFrEF) admitted for in-hospital treatment with a maximum of 2 of the indicated guideline recommended drug classes (ACE-I/ARNI/ARB, BB, MRA, SGLT2i) in the current medication plan are planned to be enrolled consecutively. Recruitment will take place at 5-7 inpatient cardiology departments at Helios hospitals trained by Helios-GDMT-Program throughout Germany.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
23 secondary outcomes
Number of recommended HF-drug classes
Time frame: Baseline to hospital discharge, on average 6 days after hospitalization/baseline
Change of percentage in HFrEF GDMT
Time frame: Baseline to 12 months
Change of 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
Time frame: Hospital Discharge (on average 6 days after hospitalization/baseline) to 12 months
Reasons for not having guideline-recommended drug classes or doses
Time frame: Hospital Discharge (on average 6 days after hospitalization/baseline) to 12 months
Number of outpatient post-discharge visits
Time frame: Hospital Discharge (on average 6 days after hospitalization/baseline) to 3 months
Proportion of patients conducting post-discharge visits
Time frame: Hospital Discharge (on average 6 days after hospitalization/baseline) to 3 months
Absolute change from baseline in NYHA class
Time frame: Measured at 6 and 12 months
Change from Baseline in blood pressure
Time frame: Baseline to 12 months
Change from Baseline in heart rate
Time frame: Baseline to 12 months
Change from Baseline in electrolyte level
Time frame: Baseline to 12 months
Change from Baseline in potassium level
Time frame: Baseline to 12 months
Change from Baseline in estimated glomerular filtrations rate
Time frame: Baseline to 12 months
Change from Baseline in serum creatinine concentration
Time frame: Baseline to 12 months
Number of rehospitalization for heart failure
Time frame: Hospital Discharge (on average 6 days after hospitalization/baseline) to 12 months
Overall Survival
Time frame: Baseline to 12 months
CV-specific survival
Time frame: Baseline to 12 months
Absolute change from baseline in Medication Adherence Report Scale (MARS)-5 questionnaire
Time frame: Measured at 6 and 12 months
Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Time frame: Measured at 6 and 12 months
Absolute change from baseline in PROMIS Global Health 10
Time frame: Measured at 6 and 12 months
Absolute change from baseline in the Nine-Item Patient Health Questionnaire (PHQ-9)
Time frame: Measured at 6 and 12 months
Number of diuretics changes
Time frame: Baseline to 12 months
Number of concomitant medication changes
Time frame: Baseline to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Disease and Heart Failure, run by AstraZeneca at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients treated with HFrEF GDMT (time frame: Baseline to hospital discharge, on average 6 days after hospitalization/baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.