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

NCT06675552 | Recruiting

• 1 other identifier: D1699R00045
• Study Type: observational
• Target: 438
• Locations: 1 country
• Sites: 6

Brief 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 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

Heart Disease; Heart Failure; Cardiovascular Disease; Heart Failure, Systolic

Keywords

Heart Failure with Reduced Ejection Fraction (HFrEF); Guideline Directed Medical Therapy; Real-World Evidence

Outcome Measures

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

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

Secondary Outcomes (23)

• 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

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (6)

Research Site

Berlin, 13125, Germany

RECRUITING

Research Site

Erfurt, 99089, Germany

RECRUITING

Research Site

Gifhorn, 38518, Germany

RECRUITING

Research Site

Leipzig, 04289, Germany

RECRUITING

Research Site

Schwerin, 19049, Germany

RECRUITING

Research Site

Wuppertal, 42117, Germany

RECRUITING

MeSH Terms

Conditions

Heart Diseases; Heart Failure; Cardiovascular Diseases; Heart Failure, Systolic

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: November 5, 2024
• Study Start: November 15, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm/ST/Submission/Disclosure
• Access Criteria: When a request has been approved, AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm/ST/Submission/Disclosure

Locations

DE (6)