Actively Recruiting

Age: 18Years - 130Years
All Genders
NCT06675552

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

Led by AstraZeneca · Updated on 2026-05-12

438

Participants Needed

6

Research Sites

136 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 130Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older at the time of signing the informed consent
  • Hospitalized in a participating site with at least 24 hours of inpatient treatment
  • Diagnosed with heart failure with reduced ejection fraction (left ventricular EF ≤ 40%) according to current European Society of Cardiology guidelines
  • Treated with a maximum of two indicated drug classes (ACE-I/ARNI/ARB, beta blockers, mineralocorticoid receptor antagonists, SGLT2 inhibitors) at admission
  • Signed and dated informed consent prior to enrollment
  • Willing and able to fulfill study requirements listed in the informed consent form
Not Eligible

You will not qualify if you...

  • Initial hospital presentation with cardiogenic shock or other types of shock
  • History of heart transplantation
  • Intolerance to one or more GDMT drug classes or significant side effects causing discontinuation of two or more substances within one drug class (except ACE-I/ARB)
  • Current or planned participation in another clinical trial
  • Investigator decision that participant is unlikely to comply with study procedures
  • Pregnancy or breastfeeding

AI-Screening

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Trial Site Locations

Total: 6 locations

1

Research Site

Berlin, Germany, 13125

Actively Recruiting

2

Research Site

Erfurt, Germany, 99089

Actively Recruiting

3

Research Site

Gifhorn, Germany, 38518

Actively Recruiting

4

Research Site

Leipzig, Germany, 04289

Actively Recruiting

5

Research Site

Schwerin, Germany, 19049

Actively Recruiting

6

Research Site

Wuppertal, Germany, 42117

Actively Recruiting

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Research Team

A

AstraZeneca Clinical Study Information Center

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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