Screening for Heart Failure in General Medicine Consultations

Active, not recruiting

• Conditions: Heart Failure

• Registration Number: NCT06865053
• Lead Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-04
• Study First Posted: 2025-03-07
• Study Start: 2025-03-14
• Status Verified: 2025-08
• Primary Completion: 2025-08
• Study Completion: 2025-08-01
• Last Update Submitted: 2025-08-05
• Last Update Posted: 2025-08-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

1. Patient consulting in general practice.
2. Aged 65 years or older

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of patients with a confirmed diagnosis of heart failure	2 months	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.
Rate of patients with an unconfirmed diagnosis of heart failure	2 months	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.
Rate of patients with an indeterminate diagnosis of heart failure	2 months	Absence of all diagnostic criteria.

Secondary Outcome Measures

Name	Time	Method
Risk factors for heart failure	Day 1
Presence of dyspnea	Day 1	Evaluation of the main symptoms of heart failure.
Weight gain	Day 1	Evaluation of the main symptoms of heart failure.
Presence of edema	Day 1	Evaluation of the main symptoms of heart failure.
Presence of fatigue	Day 1	Evaluation of the main symptoms of heart failure.

Trial Locations

Locations (6)

Maison de Santé Pluridisciplinaire La Cadière d'Azur; 🇫🇷 La Cadière d'Azur, Var, France

Maison de Santé Pluridisciplinaire La Farlède; 🇫🇷 La Farlede, Var, France

Maison de Santé Pluridisciplinaire Caduceus; 🇫🇷 La Seyne Sur Mer, Var, France

Maison de Santé Pluridisciplinaire Beaussetanne; 🇫🇷 Le Beausset, Var, France

Maison de Santé Pluridisciplinaire Vallée du Gapeau - Sollies-Pont; 🇫🇷 Sollies-pont, Var, France

Maison de Santé Pluridisciplinaire Toulon City; 🇫🇷 Toulon, Var, France