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

This study, taking place in Germany, is investigating how well hospitals are putting into practice the most up-to-date guidelines for treating heart failure. Heart failure is a serious condition where the heart struggles to pump blood effectively. Specifically, this study focuses on a type called heart failure with reduced ejection fraction (HFrEF). Researchers want to see if a special training programme for doctors helps them quickly start and adjust key heart medications while patients are still in the hospital. The aim is to understand if this approach leads to better and more consistent treatment both in the hospital and after patients return home, ultimately hoping to improve their health and reduce rehospitalisations.

At a glance

Status
Recruiting
Sponsor
AstraZeneca
Enrolment target
438
Start
15 Nov 2024
Estimated completion
30 Jun 2027

What is this study about?

Heart failure is a common and serious health problem where your heart muscle doesn't pump blood as well as it should. This can lead to symptoms like shortness of breath and tiredness. There's a specific type called heart failure with reduced ejection fraction (HFrEF) where the heart's main pumping chamber doesn't squeeze as strongly as it should. Doctors have clear guidelines on the best medicines to use for this condition, often involving a combination of different drug types.

However, studies have shown that many patients don't always receive the full recommended combination of these important medicines, or they might not start them soon enough. This trial is looking into whether providing special training to doctors in certain German hospitals can help close this gap. The training focuses on starting these essential heart medications quickly once a patient is admitted to the hospital, and then carefully adjusting the doses before they go home. The hope is that this early and thorough treatment will lead to better health outcomes for patients in the long run.

Ultimately, this study aims to see if this structured approach, starting from a patient's hospital stay, translates into continued good care once they are back home under the care of their local doctor. Researchers will observe if patients are taking the recommended medicines consistently and how their symptoms, quality of life, and hospital readmission rates are affected. It's about finding the best way to ensure patients get the most effective treatment for their heart failure.

Key takeaways

  • Study aims to improve heart failure treatment according to guidelines.
  • Focuses on a type of heart failure called HFrEF.
  • Investigates if doctor training leads to better medication use.
  • Observes existing patient care, no new treatments given.
  • Results could help improve care for future heart failure patients.

Who may be eligible?

To be considered for this study, you would need to be at least 18 years old and be currently an inpatient in one of the participating hospitals in Germany for at least 24 hours. You must have a diagnosis of heart failure with reduced ejection fraction (HFrEF), meaning your heart's pumping ability is below a certain level. At the time you're admitted to the hospital for this condition, you should be taking no more than two of the main types of heart medications recommended by the guidelines.

There are also some reasons why you wouldn't be able to join. For example, if you were admitted in a state of severe shock, or if you've already had a heart transplant, you wouldn't be eligible. If you've previously had severe side effects or intolerances to two or more medications within the same class of recommended heart drugs, you also couldn't take part. However, if you had a reaction to one type of ACE inhibitor but can tolerate another (like an ARB), you might still be able to participate. Lastly, you can't be pregnant or breastfeeding, or already be involved in another clinical trial.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years or older?
  2. Are you currently an inpatient in a participating German hospital for at least 24 hours?
  3. Have you been diagnosed with heart failure with reduced ejection fraction (HFrEF)?
  4. Are you taking two or fewer of the main recommended heart failure medications upon hospital admission?
  5. Are you pregnant or breastfeeding (exclusion if yes)?
  6. Have you had a heart transplant or severe shock (exclusion if yes)?
Answer every question to see your result.

What does participation involve?

This is a 'non-interventional study', which means you wouldn't be given any new or experimental treatments as part of the research. Instead, the study observes the usual care you receive. Your doctors will continue to treat your heart failure using the standard guidelines. The study would involve collecting information about your heart failure, the medications you're prescribed during your hospital stay, and how these are managed when you go home. Researchers will also look at how your symptoms change, your general well-being, and outcomes like whether you need to be rehospitalised. There are no specific study visits or extra medication to take beyond your standard care; information will be gathered from your routine medical records and potentially through questionnaires about your health.

Potential risks and benefits

Since this is an observational study and you would receive standard care, there are no direct medical risks from participating beyond those associated with your usual heart failure treatment. You may benefit indirectly by contributing to a better understanding of how to best implement heart failure guidelines, which could improve care for future patients. You always have the right to withdraw from the study at any time without affecting your medical care.

Locations (6)

  • Research Site
    Verified postcode
    Berlin, Germany· Recruiting
  • Research Site
    Verified postcode
    Erfurt, Germany· Recruiting
  • Research Site
    Verified postcode
    Gifhorn, Germany· Recruiting
  • Research Site
    Verified postcode
    Leipzig, Germany· Recruiting
  • Research Site
    Verified postcode
    Schwerin, Germany· Recruiting
  • Research Site
    Verified postcode
    Wuppertal, Germany· Recruiting

Common questions

What is 'heart failure with reduced ejection fraction'?

It's a type of heart failure where your heart's main pumping chamber doesn't squeeze as strongly as it should, making it harder to pump blood effectively.

What does a 'non-interventional study' mean?

It means the study observes the medical care you would already receive. You won't be given experimental drugs or asked to do anything outside of your regular treatment plan.

Why is this study important?

It helps researchers understand if special training for doctors can improve how quickly and consistently patients receive the best guideline-recommended heart failure treatments, both in hospital and after going home.

Will I have to take new medications for this study?

No, you will receive the standard medications for your heart failure as decided by your doctors according to current guidelines. The study doesn't introduce new drugs.

Does this study involve the UK?

No, this specific study is focused on hospitals within the German Helios hospital network.

How to find out more

AstraZeneca Clinical Study Information Center

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Non-interventional Study on Guideline Directed Medical Thera…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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