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
Study tests rapid heart failure medication in German hospitals
Plain English Summary
Non-interventional Study on Guideline Directed Medical Therapy for Patients With Heart Failure (HF) in Germany is a Not Applicable clinical trial sponsored by AstraZeneca studying Heart Disease, Heart Failure, Cardiovascular Disease, Heart Failure, Systolic. This study observes how quickly doctors can start and adjust guideline-recommended medications for patients with a weakened heart (heart failure with reduced ejection fraction). It is for adults hospitalized in Germany with this specific type of heart failure. Participation involves allowing researchers to review your medical records and how your heart medications are managed during your hospital stay and after discharge. There are no alternative treatments offered within this study; it observes current medical practices. The trial aims to enroll 438 participants.
Official 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. 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 dis
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and older who are hospitalized with a diagnosis of heart failure with reduced ejection fraction (heart's pumping ability ≤40%). Patients who are already taking more than two of the four main types of heart failure medications at the time of admission. Individuals experiencing shock upon admission, those who have had a heart transplant, or those with a history of severe side effects to multiple heart failure medications. This trial is studying Heart Disease, Heart Failure, Cardiovascular Disease, Heart Failure, Systolic, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The main goal is to see what percentage of patients with a weakened heart receive the recommended combination of medications by the time they leave the hospital, indicating how well the rapid treatmen The specific primary outcome measures are: Proportion of patients treated with HFrEF GDMT (Baseline to hospital discharge, on average 6 days after hospitalization/baseline). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because it aims to understand if a faster approach to starting and adjusting heart failure medications in the hospital can improve patient outcomes, addressing a gap where many pati This research targets Heart Disease, Heart Failure, Cardiovascular Disease, Heart Failure, Systolic, where improved treatment options are needed.
Investor Insight
This observational study, sponsored by AstraZeneca, examines the real-world implementation of guideline-directed medical therapy for heart failure in Germany, potentially influencing future treatment
Is This Trial Right for Me?
Ask your doctor about the specific heart failure medications you are prescribed and why. Understand how often you will need follow-up appointments after leaving the hospital to adjust your medications. Be prepared to report any side effects or how you feel on the new medications to your healthcare team. This trial is currently recruiting participants. The trial is being conducted at 6 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 438 participants
Primary Outcomes
- Proportion of patients treated with HFrEF GDMT (Baseline to hospital discharge, on average 6 days after hospitalization/baseline)
Secondary Outcomes
- 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)
Full Eligibility Criteria
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
Trial Locations
- Research Site, Berlin, Germany
- Research Site, Erfurt, Germany
- Research Site, Gifhorn, Germany
- Research Site, Leipzig, Germany
- Research Site, Schwerin, Germany
- Research Site, Wuppertal, Germany
Frequently Asked Questions
What is clinical trial NCT06675552?
NCT06675552 is a Not Applicable OBSERVATIONAL study titled "Non-interventional Study on Guideline Directed Medical Therapy for Patients With Heart Failure (HF) in Germany." It is currently recruiting and is sponsored by AstraZeneca. The trial targets enrollment of 438 participants.
What conditions does NCT06675552 study?
This trial investigates treatments for Heart Disease, Heart Failure, Cardiovascular Disease, Heart Failure, Systolic. The primary condition under study is Heart Disease.
What does Not Applicable mean for NCT06675552?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT06675552?
This trial is currently "Recruiting." It started on 2024-11-15. The estimated completion date is 2027-06-30.
Who is sponsoring NCT06675552?
NCT06675552 is sponsored by AstraZeneca. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06675552?
The trial aims to enroll 438 participants. The trial is currently recruiting and accepting new participants.
How is NCT06675552 designed?
This is a observational study.
What are the primary outcomes being measured in NCT06675552?
The primary outcome measures are: Proportion of patients treated with HFrEF GDMT (Baseline to hospital discharge, on average 6 days after hospitalization/baseline). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06675552 being conducted?
This trial is being conducted at 6 sites, including Berlin; Erfurt; Gifhorn; Leipzig and 2 more sites (Germany).
Where can I find official information about NCT06675552?
The official record for NCT06675552 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06675552. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06675552 testing in simple terms?
This study observes how quickly doctors can start and adjust guideline-recommended medications for patients with a weakened heart (heart failure with reduced ejection fraction). It is for adults hospitalized in Germany with this specific type of heart failure.
Why is this trial significant?
This trial matters because it aims to understand if a faster approach to starting and adjusting heart failure medications in the hospital can improve patient outcomes, addressing a gap where many pati
What are the potential risks of participating in NCT06675552?
Potential side effects from the heart failure medications can include dizziness, fatigue, cough, or changes in kidney function. Some patients may experience intolerance to certain drug classes, requiring careful monitoring and adjustment by their doctor. There's a risk that the rapid medication strategy might not be suitable for all patients, especially those with complex conditions or severe shock. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06675552?
Ask your doctor about the specific heart failure medications you are prescribed and why. Understand how often you will need follow-up appointments after leaving the hospital to adjust your medications. Be prepared to report any side effects or how you feel on the new medications to your healthcare team. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06675552 signal from an investment perspective?
This observational study, sponsored by AstraZeneca, examines the real-world implementation of guideline-directed medical therapy for heart failure in Germany, potentially influencing future treatment This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves allowing researchers to review your medical records and how your heart medications are managed during your hospital stay and after discharge. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.