Screening for Heart Failure in General Medicine Consultations

NCT06865053 | Completed

• 1 other identifier: 2025-CHITS-003
• Study Type: observational
• Target: 216
• Locations: 1 country
• Sites: 6

Brief Summary

Heart failure poses a significant public health challenge due to its high prevalence and the substantial human and financial costs it generates. Furthermore, the lack of clear screening guidelines and challenges in accessing care and multi-professional coordination, contribute to diagnostic delays, leading more patients to seek care in more severe clinical states and requiring direct admission to emergency departments. There is therefore also a major organizational challenge in better managing the entry of patients into the healthcare system. This necessitates the development of structured heart failure screening strategies. The 2021 European Society of Cardiology (ESC 2021) guidelines on heart failure screening prioritize the identification of at-risk individuals and the early detection of disease manifestations. They suggest that, in high-risk groups, tests such as echocardiography and biomarker measurement (NT-proBNP) should be used to detect heart failure at an early stage, even in the absence of symptoms. The guidelines also delineate specific biomarker thresholds and propose organizational frameworks with defined timelines to facilitate systematic screening. The implementation of a heart failure screening pathway within primary care involving multi-professional cooperation is therefore warranted. Stratifying screening based on risk factors and symptomatology is expected to enhance the positive predictive value of the screening process. Furthermore, evaluating the efficacy of this pathway is crucial for establishing a standardized, reproducible clinical protocol suitable for routine primary care practice. This study is a prospective, multicenter, observational study conducted within the context of routine clinical care.

Conditions

Heart Failure

Keywords

heart failure; screening; general medicine; care pathway; Multi-professional cooperation

Outcome Measures

Primary Outcomes (3)

• Rate of patients with a confirmed diagnosis of heart failure

  i.e. patients with at least one "yes" box checked in "step 1" and "step 2" of the questionnaire, with an NT-proBNP level ≥ 125 pg/ml, and an echocardiographic examination performed by the cardiologist confirming a diagnosis of HF according to the 2021 ESC guidelines.

  2 months

• Rate of patients with an unconfirmed diagnosis of heart failure

  i.e. all of the following patients: * Patients with no "yes" boxes checked in steps 1 and 2 of the questionnaire OR one or more "yes" boxes checked but in only one of steps 1 or 2. * Patients with at least one "yes" box checked in "step 1" and "step 2" of the questionnaire but with an NT-proBNP level \< 125 pg/ml.

  2 months

• Rate of patients with an indeterminate diagnosis of heart failure

  Absence of all diagnostic criteria.

  2 months

Secondary Outcomes (5)

• Risk factors for heart failure

  Day 1

• Presence of dyspnea

  Day 1

• Weight gain

  Day 1

• Presence of edema

  Day 1

• Presence of fatigue

  Day 1

Study Arms (1)

Patients participating in the heart failure screening pathway in general medicine consultations

Other: Heart failure screening pathway

Interventions

Heart failure screening pathway OTHER

Heart failure screening pathway in general medicine consultations (questionnaire, NT-proBNP level, echocardiographic examination)

Patients participating in the heart failure screening pathway in general medicine consultations

Eligibility Criteria

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

Study Population

Patients aged 65 years or older participating in the heart failure screening pathway in general medicine consultations

You may qualify if:

• Patient consulting in general practice.
• Aged 65 years or older

You may not qualify if:

• Known heart failure.
• Patient who has already consulted a cardiologist within the last 12 months.
• Patient opposition to participate in the study

Sponsors & Collaborators

• Cerballiance: collaborator
• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead
• Roche Diagnostic Ltd.: collaborator

Study Sites (6)

Maison de Santé Pluridisciplinaire La Cadière d'Azur

La Cadière-d'Azur, Var, 83740, France

Location

Maison de Santé Pluridisciplinaire La Farlède

La Farlède, Var, 83210, France

Location

Maison de Santé Pluridisciplinaire Caduceus

La Seyne-sur-Mer, Var, 83500, France

Location

Maison de Santé Pluridisciplinaire Beaussetanne

Le Beausset, Var, 83330, France

Location

Maison de Santé Pluridisciplinaire Vallée du Gapeau - Sollies-Pont

Solliès-Pont, Var, 83210, France

Location

Maison de Santé Pluridisciplinaire Toulon City

Toulon, Var, 83000, France

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Jean-Michel TARTIERE, MD

  Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 7, 2025
• Study Start: March 14, 2025
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

FR (6)