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Heart Failure (HF)EDIT-HFNCT07731490

Early Detection and IntervenTion in Heart Failure

A study testing Intervention bundle comprising increased awareness, early diagnostics, and early treatment to improve HF prognosis. in people with Heart Failure (HF), run by University Hospital, Basel, Switzerland at 21 sites in 9 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Heart Failure (HF)
What is being tested?
Intervention bundle comprising increased awareness, early diagnostics, and early treatment to improve HF prognosis.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18,000 participants
Where
21 sitesin 9 countries
Study dates
3 Dec 2025to Apr 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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).
  • Exclusion criteria are assessed on day 1 after the procedure

Who cannot join

  • 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.
Show all 13Show fewer
  • 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

Trial locations and contacts

21 sites in 9 countries. Contact the study team or a site near you to ask about taking part.

Christian Müller, Prof. Dr. contact

+41 61 328 65 49

Christian.Mueller@usb.ch

Sonja Horvat, Dr. contact

sonja.horvat-csoti@usb.ch

21 sites in 9 countries

Switzerland11 sites, 11 recruiting
  • KSA Kantonsspital Aarau

    Aarau, 5001

    Laurent Haegeli, Prof. Dr., + 41 62 838 44 81, laurent.haegeli@ksa.ch

    Not yet recruiting
  • Cantonal Hospital Baden

    Baden, 5404

    Maria Wertli, Prof. Dr., +41 56 486 25 02, Maria.Wertli@ksb.ch

    Not yet recruiting
  • University Hospital Basel

    Basel, Basel, 4031

    Christian Müller, Prof. Dr., +41 61 328 65 49, Christian.Mueller@usb.ch

    Recruiting
  • St. Claraspital AG

    Basel, 4058

    Lukas Altwegg, Dr., +41 61 685 83 80, kardiologiesekretariat@claraspital.ch

    Not yet recruiting
  • University Hospital Genève

    Geneva, 1205

    Philippe Meyer, +41 22 372 72 00, philippe.meyer@hug.ch

    Francois Mach, Prof. Dr.

    Not yet recruiting
  • University Hospital Lausanne

    Lausanne, Lausanne, 1005

    Baris Gencer, Prof. Dr., +41 21 314 00 10, baris.gencer@chuv.ch

    Not yet recruiting
  • Kantonsspital Luzern

    Lucerne, 6000

    Matthias Paul, Dr., +41 41 205 51 06, matthias.paul@luks.ch

    Not yet recruiting
  • Hospital Istituto Cardiocentro Ticino

    Lugano, 6900

    Marco Valgimigli, Prof. Dr., +41 91 811 53 63, Marco.Valgimigli@eoc.ch

    Not yet recruiting
  • Kantonsspital St. Gallen

    Sankt Gallen, 9007

    Konstantinos Rizas, Prof. Dr., +41 71 494 10 51, konstantinos.rizas@h-och.ch

    Not yet recruiting
  • Stadtspital Zürich

    Zurich, 8063

    Jeger Raban, Prof. Dr., +41 44 416 34 11, raban.jeger@stadtspital.ch

    Not yet recruiting
  • University Hospital Zurich

    Zurich, 8091

    Andreas Flammer, Prof. Dr., +41 44 255 11 11, andreas.flammer@usz.ch

    Not yet recruiting

Other trials in Switzerland

Germany3 sites, 3 recruiting
  • University Hospital Freiburg-Bad Krozingen

    Freiburg im Breisgau, 79106

    Christoph Ahlgrim, Dr., +49 761 270-0, christoph.ahlgrim@uniklinik-freiburg.de

    Not yet recruiting
  • Universitätsklinikum der Ruhr-Universität Bochum

    Herne, 44625

    Christian Ukena, Prof. Dr., +49 2323 499 1604, kardiologie@marienhospital-herne.de

    Not yet recruiting
  • Herzzentrum Leipzig, Klinik für Innere Medizin/Kardiologie

    Leipzig, 04289

    Holger Thiele, Prof. Dr., +493418651428, holger.thiele@medizin.uni-leipzig.de

    Not yet recruiting

Other trials in Germany

Austria1 site, 1 recruiting
  • Universitätsklinik für Innere Medizin II

    Vienna, 1090

    Paul Haller, Dr., +43 1 40400 46140, kardiologie@meduniwien.ac.at

    Not yet recruiting

Other trials in Austria

Bulgaria1 site, 1 recruiting
  • Queen Giovanna University Hospital

    Sofia, 1527

    Assen Goudev, Prof. Dr., +359 2 943 2584, agoudev@abv.bg

    Not yet recruiting

Other trials in Bulgaria

Italy1 site, 1 recruiting
  • University Hospital Pisa

    Pisa, 56126

    Luna Gargani, Dr., +39 050 221 2111, luna.gargani@unipi.it

    Not yet recruiting

Other trials in Italy

Netherlands1 site, 1 recruiting
  • Erasmus MC Rotterdam

    Rotterdam, 3015

    Rudolf A. De Boer, Prof. Dr., + 31 10 704 0 704, r.a.deboer@erasmusmc.nl

    Not yet recruiting

Other trials in Netherlands

South Korea1 site, 1 recruiting
  • Konkuk University Medical Center

    Seoul

    Hyun Suk Yang, Dr, 15881533, yang.hyun@gmail.com

    Recruiting

Other trials in South Korea

Spain1 site, 1 recruiting
  • University Hospital Ramón y Cajal Madrid

    Madrid, 28034

    Jose Louis Zamorano, Prof. Dr., +34 913 36 80 00, zamorano@secardiologia.es

    Not yet recruiting

Other trials in Spain

United Kingdom1 site, 1 recruiting
  • Royal Infirmary Edinburgh

    Edinburgh, EH16 4SB

    Nicholas Mills, Prof. Dr., +44 131 242 1000, nick.mills@ed.ac.uk

    Not yet recruiting

Other trials in United Kingdom

About this study

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:

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

The researchers will assess whether this strategy effectively reduces hospitalizations due to acute heart failure over an 18-month follow-up period.

Read the detailed description

Heart failure (HF) is a significant global health issue, affecting approximately 64 million individuals worldwide and resulting in over a million hospitalizations annually in Europe and the US. This imposes substantial healthcare costs exceeding $100 billion yearly, with about 70% attributed to acute hospitalizations. The aging population contributes to a rising burden, as HF is often diagnosed late, even in well-funded healthcare settings. Recent insights from studies, including the ongoing BASEL VIII study, challenge the assumption that undetected HF is primarily a failure to detect HF in primary care, revealing a high prevalence of undetected HF even among patients treated by cardiologists. This research initiative revealed that among patients ≥ 65 years, only 3% had known HF, while 29% had undetected HF. Similar observations were also noted in various high-risk settings worldwide, suggesting a surprisingly high rate of undetected HF in clinical practice. Late diagnosis is driven by gradual symptom development, non-specific symptoms often attributed to aging, insensitive clinical signs, and inadequate utilization of B-type natriuretic peptide (BNP) or N-terminal pro-B-type natriuretic peptide (NT-proBNP) testing, the recommended tools for HF diagnosis. The misconception that HF competes with other cardiac diagnoses, rather than complementing them, further contributes to delayed diagnosis. Emerging evidence supports a strategy combining increased awareness, active surveillance using NT-proBNP testing for early HF diagnosis, and prompt treatment with approved evidence-based therapies to reduce HF hospitalizations. However, such intervention bundles are not systematically applied, as no randomized controlled trial (RCT) has ever investigated the efficacy of such structured interventions on hard outcomes. This research initiative aims to assess the effectiveness of an intervention bundle comprising increased awareness, early diagnostics, and early treatment to improve HF prognosis. 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. By addressing these challenges, the initiative seeks to enhance patient outcomes, reduce the burden on healthcare systems, and contribute to advancing HF care. The bundle intervention, comprising an educational program, guidelines-directed diagnostics, and guidelines-supported management, represents a proactive implementation of best clinical practice. As this proactive approach is not routinely implemented in real-world clinical dynamics, this study primarily focuses on accompanying the implementation of the intervention bundle and contributing valuable data regarding its efficacy. At the same time, the intervention is expected to offer a number of potential benefits for the patients, their health care providers, and the society in general. This will be achieved by a better understanding of the HF problem among patients and medical staff, better adherence to guidelines-supported best clinical practices, and the potential avoidance of hospitalisations due to acute HF.

Being tested
Intervention bundle comprising increased awareness, early diagnostics, and early treatment to improve HF prognosis.
Keywords
NT-proBNP, Stepped-Wedge, Undetected Heart Failure, Heart Failure, Implementation Science
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07731490
Study groupRoleWhat they receive
Phase INo interventionNot described
Phase IIOtherIntervention
Receives: Other: Intervention bundle comprising increased awareness, early diagnostics, and early treatment to improve HF prognosis.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 18 months after intervention

Secondary outcomes (9)
  1. CV death or acute HF event

    Time from index hospitalisation to acute HF event, CV death or follow-up date, together with binary variable indicating the occurrence of acute HF event or CV death.

    Measured: 18 months

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

    Hierarchical ordinal composite of CV death, acute HF hospitalization, acute HF during index hospitalization, and no event (analyzed using the Finkelstein-Schoenfeld win ratio framework. Ties will be resolved according to the predefined event hierarchy. The effect measure will be the win ratio with 95% confidence intervals and two-sided p-values).

    Measured: 18 months

  3. All-cause death

    Time from index hospitalisation to hospitalization for acute HF, death, or follow-up date, together with binary variable indicating the occurrence of hospitalization for acute HF or death.

    Measured: 18 months

  4. Cardiovascular death

    Time from index hospitalisation to CV death or follow-up date, together with binary variable indicating CV death.

    Measured: 18 months

  5. All-cause hospitalizations

    Time from index hospitalisation to hospitalization for acute HF, death, or follow-up date, together with binary variable indicating the occurrence of hospitalization for acute HF or death.

    Measured: 18 months

  6. Changes in medical treatment between the index hospitalisation

    Categorical variables indicating changes in specific medical treatments. Changes in medication list (dosage, active pharmaceutical ingredient) during the periods of 1) before index presentation until discharge and 2) after discharge from the index hospitalization up to the 18-month follow-up period measured from the time of the intervention

    Measured: 18 months

  7. Change in kidney function

    Standard blood tests obtained during routine clinical care like serum creatinine indicating changes in the kidney function.

    Measured: 18 months

  8. Health economic outcomes: cost of patient management

    Cost of patient treatment within 18 months after the index hospitalisation, from different perspectives: hospital real costs perspective, full institutional perspective (considering real costs and reimbursements), healthcare payer perspective.

    Measured: 18 months

  9. Health economic outcome: cost-effectiveness in terms of cost per hospitalization for acute HF avoided

    Cost of patient treatment within 18 months after the index hospitalisation and number of hospitalizations for acute HF within 18 months after the index hospitalisation.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2026
  2. Study start3 Dec 2025
  3. Primary completionApr 2028 (estimated)
  4. Study completionApr 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective Stepped-Wedge Cluster Randomised Controlled Multicentre Interventional Trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
18,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07731490
Sponsor's protocol ID
2024-02339
Acronym
EDIT-HF
Status last verified
Jul 2026
First submitted
9 Jul 2026
Last updated
28 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Intervention bundle comprising increased awareness, early diagnostics, and early treatment to improve HF prognosis. in people with Heart Failure (HF), run by University Hospital, Basel, Switzerland at 21 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Switzerland, Germany, Austria, Bulgaria, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Christian Müller, Prof. Dr. (+41 61 328 65 49, Christian.Mueller@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute HF event (time frame: 18 months after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.

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