Early Detection and IntervenTion in Heart Failure

NCT07731490 | Recruiting DMC

• 1 other identifier: 2024-02339
• Study Type: interventional
• Target: 18,000
• Locations: 9 countries
• Sites: 21

Brief Summary

Heart failure (HF) occurs when the heart is no longer able to pump blood effectively throughout the body. This leads to symptoms that gradually worsen over time and are often mistaken for normal signs of aging. Because of its insidious onset, early detection is challenging. Both patients and healthcare professionals are often insufficiently aware of the early signs and symptoms of HF, resulting in delayed diagnosis. Consequently, timely initiation of treatments that could slow disease progression, improve quality of life, and reduce hospitalizations is often missed. Although a simple blood test measuring NT-proBNP levels can facilitate the early diagnosis of HF, it is not routinely used in clinical practice. The aim of this study is to evaluate whether a combined strategy for the early diagnosis and treatment of HF can reduce hospitalizations. This strategy includes:

1. 1.increasing awareness of HF among patients and physicians,
2. 2.using NT-proBNP testing for the early detection of HF in high-risk patients, and
3. 3.promptly initiating guideline-directed HF treatment when the diagnosis is confirmed.

Conditions

Heart Failure (HF)

Keywords

NT-proBNP; Stepped-Wedge; Undetected Heart Failure; Heart Failure; Implementation Science

Outcome Measures

Primary Outcomes (1)

• Acute HF event

  Time from the index procedure to an acute HF event or follow-up date, together with binary variable indicating the occurrence of an acute Hf event. Acute HF event during index hospitalization is defined as acute HF severe enough to require admission to an intensive/intermediate care unit, non-invasive ventilation, or treatment with at least 40mg furosemide IV.

  18 months after intervention

Secondary Outcomes (9)

• CV death or acute HF event

  18 months

• Hierarchical ordinal composite of CV death, acute HF hospitalization, acute HF during index hospitalization, and no event

  18 months

• All-cause death

  18 months

• Cardiovascular death

  18 months

• All-cause hospitalizations

  18 months

Other Outcomes (3)

• Outcomes for implementation

  18 months

• Prevalence of undetected / untreated / suboptimal treated HF patients overall and in the different medical settings

  18 months

• Ratio between previously known and undetected HF overall and in the different medical settings, and the corresponding number needed to screen to detect one patient with undetected HF

  18 months

Study Arms (2)

Phase I

NO INTERVENTION

Phase II

OTHER

Intervention

Other: Intervention bundle comprising increased awareness, early diagnostics, and early treatment to improve HF prognosis.

Interventions

Intervention bundle comprising increased awareness, early diagnostics, and early treatment to improve HF prognosis. OTHER

The study aims to fill critical gaps and evaluate patient-centred outcomes, including hospitalization for acute HF, and health economic implications by using routine clinical data and the standard operating procedures as part of routine clinical practice in the participating sites.

Phase II

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• General consent (GC) has not been rejected.
• Age ≥ 65 years.
• Elective percutaneous coronary intervention\* (PCI), pulmonary vein isolation\* (PVI), pacemaker implantation\* (PM, no cardiac resynchronisation), transcatheter aortic valve intervention\* (TAVI), major non-cardiac surgery\* or presenting with tachyarrhythmia to the emergency department (ED) (without a diagnosis of HF within 24h).

You may not qualify if:

• Systolic blood pressure ≤ 95 mmHg
• Estimated glomerular filtration rate (GFR) \<30 mL/min/1.73 m2.
• Dementia documented in the medical history.
• Metastatic cancer in the medical history.
• Previously enrolled in this study.
• Known HF.
• Known allergies, hypersensitivity, or intolerance to SGLT2 Inhibitors / Loop Diuretics / MRA or is excipients.
• Non-resident in the country of the recruiting site
• Incapacity of the patient to make judgements
• Patients not hospitalized overnight
• Patients requiring intensive care unit (ICU) or intermediate care (IMC) stay beyond 11:00 a.m. on the first postoperative day or any post-interventional stroke unit stay until 8:00 a.m. on the first postoperative day.
• Patients died prior to postinterventional day 1 (8:00 a.m.)
• Severe aortic or mitral stenosis

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (21)

Universitätsklinik für Innere Medizin II

Vienna, 1090, Austria

NOT YET RECRUITING

Queen Giovanna University Hospital

Sofia, 1527, Bulgaria

NOT YET RECRUITING

University Hospital Freiburg-Bad Krozingen

Freiburg im Breisgau, 79106, Germany

NOT YET RECRUITING

Universitätsklinikum der Ruhr-Universität Bochum

Herne, 44625, Germany

NOT YET RECRUITING

Herzzentrum Leipzig, Klinik für Innere Medizin/Kardiologie

Leipzig, 04289, Germany

NOT YET RECRUITING

University Hospital Pisa

Pisa, 56126, Italy

NOT YET RECRUITING

Erasmus MC Rotterdam

Rotterdam, 3015, Netherlands

NOT YET RECRUITING

Konkuk University Medical Center

Seoul, South Korea

RECRUITING

University Hospital Ramón y Cajal Madrid

Madrid, 28034, Spain

NOT YET RECRUITING

University Hospital Basel

Basel, Basel, 4031, Switzerland

RECRUITING

University Hospital Lausanne

Lausanne, Lausanne, 1005, Switzerland

NOT YET RECRUITING

KSA Kantonsspital Aarau

Aarau, 5001, Switzerland

NOT YET RECRUITING

Cantonal Hospital Baden

Baden, 5404, Switzerland

NOT YET RECRUITING

St. Claraspital AG

Basel, 4058, Switzerland

NOT YET RECRUITING

University Hospital Genève

Geneva, 1205, Switzerland

NOT YET RECRUITING

Kantonsspital Luzern

Lucerne, 6000, Switzerland

NOT YET RECRUITING

Hospital Istituto Cardiocentro Ticino

Lugano, 6900, Switzerland

NOT YET RECRUITING

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

NOT YET RECRUITING

Stadtspital Zürich

Zurich, 8063, Switzerland

NOT YET RECRUITING

University Hospital Zurich

Zurich, 8091, Switzerland

NOT YET RECRUITING

Royal Infirmary Edinburgh

Edinburgh, EH16 4SB, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Christian Müller, Prof. Dr.

CONTACT

+41 61 328 65 49; Christian.Mueller@usb.ch

Sonja Horvat, Dr.

CONTACT

sonja.horvat-csoti@usb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective Stepped-Wedge Cluster Randomised Controlled Multicentre Interventional Trial

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 28, 2026
• Study Start: December 3, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2030
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

IT (1); NL (1); DE (3); AU (1); ES (1); BU (1); KR (1); CH (11); GB (1)