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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-130
SponsorAstraZeneca

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

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

Secondary outcomes

1

Number of recommended HF-drug classes

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

Time frame
Baseline to hospital discharge, on average 6 days after hospitalization/baseline
2

Change of percentage in HFrEF GDMT

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

Time frame
Baseline to 12 months
3

Change of phenotype-concordant guideline-recommended HF drug classes

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

Time frame
Hospital Discharge (on average 6 days after hospitalization/baseline) to 12 months
4

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

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

Other outcomes

Sponsors and contacts

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