Heart FailureHEART-CAMFiCNCT07339007
Observational Study to Validate a Family Physician Echocardiography Training Programme
An observational study of Heart Failure and Valvular Heart Diseases, run by Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC) at 1 site in Spain.
Trial summary
Observational Study on the Validation of Family Doctors' Training in Echocardiography The Catalan Society of Family and Community Medicine (CAMFiC) developed a structured training program for Family Physicians in focused cardiac ultrasound (FoCUS). Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Heart Failure, Valvular Heart Diseases, Atrial Fibrillation (AF)
- What is being tested?
- Cohort of GPs: Training program and Cohort of patients
- How many people
- 500 participants
- Where
- 1 siteSpain
- Study dates
- 12 Sep 2023to 31 Dec 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will consist of: * GPs who meet the eligibility criteria and complete the FoCUS training programme, regardless of workplace setting. * Patients aged >15 years receiving routine care at sites where participating GPs work, in whom a FoCUS assessment is clinically indicated, and who provide written informed consent for inclusion in the paired FoCUS-comprehensive echocardiography agreemnt study.
Who may be able to join
- Inclusion criteria for professionals in the training program are:
- Board-certified specialist in Family and Community Medicine.
- Member of the Catalan Society of Family and Community Medicine (CAMFiC).
- Access at the workplace to an ultrasound device suitable for FoCUS.
- Willing and able to complete all training and study procedures. Exclusion criteria: Not meeting any inclusion criterion.
- The inclusion criteria for patients are:
Show all 10Show fewer
- Age over 18 years old.
- Clinical indication for FoCUS/echocardiographic assessment in routine care.
- Attended at a site where a participating GP provides care.
- Able to provide written informed consent.
Who cannot join
- Refusal to participate (no written informed consent)
- Severe mental illness
- Significant cognitive impairment preventing informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Societat Catalana de Medicina Familiar i Comunitària (CAMFiC)
Barcelona, Catalonia, 08009
About this study
Observational Study on the Validation of Family Doctors' Training in Echocardiography
The Catalan Society of Family and Community Medicine (CAMFiC) developed a structured training program for Family Physicians in focused cardiac ultrasound (FoCUS). This study evaluates GP FoCUS performance against comprehensive echocardiography and assesses training competence.
Developed between September 2023 and November 2025 (92 hours total, including 70 hours supervised practice), participants perform FoCUS on patients with suspected cardiac pathology. The study measures concordance between GP FoCUS and cardiologist echocardiography, and evaluates FoCUS integration into primary care pathways to enhance diagnostic capacity for common cardiac conditions.
Read the detailed description
ACKGROUND \& JUSTIFICATION Cardiovascular disease generates long cardiology waiting lists in Spain (>90 days echocardiography). Elderly patients discharged from hospital require cardiac follow-up in primary care, but Family Medicine residency (MIR) excludes point-of-care ultrasound (POCUS) training. This gap limits GP triage capacity for common cardiac pathology.
The Catalan Society of Family and Community Medicine (CAMFiC), in collaboration with the Catalan Society of Cardiology (SCC), developed a structured FoCUS training program (2022, 92 hours total: 18h theory + 4h workshop for cardiac views + 70h supervised hospital practice) to empower primary care physicians.
HYPOTHESIS
Primary Hypotheses:
- Structured FoCUS training enables GPs to achieve competency across ≥6/7 predefined domains (standard views, LVEF estimation, RV/volume assessment, valvular disease detection, pericardial effusion, LVH recognition, theoretical knowledge).
- This training program achieves ≥80% concordance between GP-performed FoCUS and cardiologist-performed standard echocardiography on predefined cardiac parameters (κ≥0.6). Secondary Hypotheses:
- Trained GP will be able to integrate this technique into routine practice (≥1 scan/week).
- FoCUS enables documentation of key cardiac pathologies (LVEF impairment, RV dilation, significant valve disease, pericardial effusion) among primary care scans performed for clinical indications (dyspnea, heart murmur, suspected HF, arrhythmia).
- FoCUS plus clinical data identifies ≥3 distinct patient profiles among primary care patients assessed.
- FoCUS in primary care achieves appropriate triage of patients requiring formal echocardiography.
- The programme will be acceptable to stakeholders, with high satisfaction reported by patients, family doctors, and cardiologists participating in the programme.
- FoCUS in primary care will increase identification of suspected heart failure among assessed patients and may reduce time to appropriate management.
STUDY OVERVIEW Prospective observational study (CEIm IDIAP 23/072-P). 46 CAMFiC GPs perform FoCUS on consecutive adult patients (>18 years) with clinical cardiac indication during primary care visits, followed by cardiologist echocardiography confirmation. Data captured via REDCap eCRF.
See Outcomes, Eligibility Criteria, and Arms/Interventions for specific measures, criteria, and procedures.
PHASES
- Phase 0: Preparation (2022)
- Phase 1: Training (2022-2025)
- Phase 2: Data collection (2024-2027)
- Phase 3: Analysis (kappa/ICC/Bland-Altman, mixed models) (2027-2028)
- Phase 4: Dissemination (PhD thesis, peer-reviewed publications) (2028)
CLINICAL IMPACT Reduces time-to-diagnosis, shortens cardiology waiting lists, enables primary care triage of common cardiac conditions, cost-effective, scalable model.
PROTOCOL AVAILABILITY Full protocol available upon request from IDIAP Jordi Gol Primary Care Research Institute.
See structured sections (Outcomes, Eligibility Criteria, Arms/Interventions) for specific measures, criteria, and procedures.
- Conditions
- Heart Failure, Valvular Heart Diseases, Atrial Fibrillation (AF), Arterial Hypertension, Cardiomyopathies
- Being tested
- Cohort of GPs: Training program, Cohort of patients
- Keywords
- Primary Health Care, Echocardiography, Family Practice, Ultrasound Training, Ultrasonography, Education, Medical
- Medical subject headings
- Heart Failure, Heart Valve Diseases, Atrial Fibrillation, Hypertension, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohort of GPs: Training programOther
- Accredited curriculum: 18 hours of online theory (2.7 CCFCPS credits) with a mandatory 20-item MCQ assessing knowledge and image interpretation.
- Structured, supervised scanning volume: 4-hour hands-on introductory session on core cardiac views using healthy volunteers, followed by 70 hours of supervised clinical training with a hospital cardiologist, including a predefinied target of 60 FoCUS examinations per GP.
Cohort of patientsDiagnostic test
Eligible patients are those seen in routine primary care by participating GPs who, based on usual clinical judgment, need an echocardiographic assessment. In these cases, the GP will perform a FoCUS scan as part of the consultation and record a standard set of variables in the study eCRF. When the patient subsequently undergoes a comprehensive echocardiography in cardiology, both assessments (GP FoCUS and cardiology echocardiography) will be paired to evaluate agreement. No additional tests or extra study visits are required beyond usual care.
| Study group | Role | What they receive |
|---|---|---|
| Cohort of GPs | Cohort of GPs:
Board-certified Family and Community Medicine specialists in Catalonia who will complete a structured FoCUS training programme and participate in a validation study.
Intervention of interest: FoCUS training (online theory + supervised hands-on practice, including simulator assessment) followed by routine FoCUS use in primary care with data capture in REDCap and paired comparison with cardiologist echocardiography.
Inclusion criteria: Family and Community Medicine specialist; CAMFiC member; workplace access to an ultrasound device suitable for FoCUS; commitment to complete the programme.
Exclusion criteria: Not meeting any inclusion criterion. Receives: Other: Cohort of GPs: Training program | |
| Cohort of Patients | Cohort of Patients:
Individuals aged >18 years who require cardiac imaging for any clinical indication in routine care at a site where a participating GP works.
Intervention of interest: A FoCUS assessment performed by the trained GP as part of usual clinical care; no additional study tests or follow-up visits.
Sampling: Non-random, consecutive/clinician-driven recruitment based on routine clinical need and medical judgment.
Exclusion criteria: Refusal to participate (no written informed consent) and severe mental illness or significant cognitive impairment preventing informed consent. Receives: Diagnostic Test: Cohort of patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between GP-performed FoCUS and cardiologist-performed standard echocardiography.
Agreement between GP-performed FoCUS and cardiologist-performed standard echocardiography on key cardiac parameters: left ventricular systolic function (preserved vs. reduced), cavity sizes (normal vs. dilated), and significant valve abnormalities (none vs. moderate-severe). Additional parameters include pericardial effusion and IVC dilation. Measured by weighted kappa coefficient comparing blinded independent interpretations of the same patients. Higher κ = better agreement. Clinical competency threshold κ ≥ 0.6 (substantial agreement).
Unit of measure: Weighted kappa coefficient (0-1)
Measured: Diagnostic agreement assessment in real-world clinical practice following training completion (2024-2027 recruitment period).
Secondary outcomes (5)
GPs knowledge and competence after FoCUS training
Change from baseline in 20-item MCQ knowledge score + % practical competencies checklist + simulator pass rate, assessing FoCUS training effectiveness for GPs (Objective 1).
Measured: Training completion (6-8 months post-enrolment)
FoCUS routine integration in clinical practice
Proportion of trained GPs regularly using FoCUS (≥1/week) in primary care consultations, assessed by participant survey at end of recruitment (Objective 3).
Measured: Following completion of recruitment (December 2027), a survey will be conducted among the 46 family physicians who have participated in this training program to assess the proportion regularly applying FoCUS (≥1/week) in routine primary care consultation
FoCUS indications and abnormalities documented.
Frequency of predefined indications (dyspnea, heart murmur, suspected heart failure, cardiac arrhythmia) and key abnormalities documented during routine FoCUS use (Objective 4).
Measured: Documentation analysis of FoCUS performed during study period for clinical indications and documented key abnormalities: first half of 2028 (January-June 2028), following recruitment completion and REDCap data extraction.
Time from FoCUS triage to specialist care
Time elapsed from the detection of significant cardiac findings using FoCUS to care by a specialist/echocardiography in general practitioners trained in FoCUS versus standard care, evaluating the benefits of triage and accelerated care pathways (hypothesis 6+8).
Measured: Real-world implementation (2024-2027)
Programme acceptability and satisfaction
Satisfaction scores (1-5 Likert scale) from patients, GPs, and cardiologists regarding FoCUS programme acceptability and usability (Objective 7).
Measured: Programme completion (2027)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start12 Sep 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (59)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC)
- Sponsor type
- University, hospital or other
- Collaborators
- University of Barcelona, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Responsible party
- Principal investigator, Monica Solanes Cabus, Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC)
- Investigators
- Antoni Sisó-Almirall, Ph.D., Study director, IDIBAPS. CAMFiC.Laura Conangla-Ferrín, Ph.D., Study director, Institut Catlà de la Salut. CAMFiC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339007
- Sponsor's protocol ID
- HEART-CAMFiC FoCUS Study Group
- Acronym
- HEART-CAMFiC
- Status last verified
- Jan 2026
- First submitted
- 10 Dec 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient data will be collected in a pseudonymised format in REDCap, a secure platform for clinical research data management. Access to the dataset will be restricted to authorised members of the research team and used solely to address the study objectives. Data handling will comply with applicable data protection regulations, safeguarding confidentiality throughout the study and subsequent analyses. There is no plan to share individual participant data (IPD) outside the study team.
Publications
Solanes-Cabús M, Pujol-Salud J, Alonso-Aliaga J, Mayench-Ariza F, Marsal-Mora JR, Sabaté-Navarro A, et al. Inter-rater agreement and reliability among general practitioners and radiologists on ultrasound examinations after a specialized training program [Internet]. Journal of Primary Health Care & General Practice. 2019;3(1):026 [cited 2025 Oct 25]. Available from: https://www.scribd.com/document/877574246/
Sorensen B, Hunskaar S. Point-of-care ultrasound in primary care: a systematic review of generalist performed point-of-care ultrasound in unselected populations. Ultrasound J. 2019 Nov 19;11(1):31. doi: 10.1186/s13089-019-0145-4.
PubMed 31749019British Medical Ultrasound Society; Royal College of Radiologists. Recommendations for specialists practising ultrasound independently of radiology departments: safety, governance and education [Internet]. London: Royal College of Radiologists; 2023 Apr [cited 2025 Oct 26]. Available from: https://www.rcr.ac.uk/publication/recommendations-for-specialists-practising-ultrasound-independently-of-radiology-departments-safety-governance-and-education/
Conangla-Ferrin L, Guirado-Vila P, Solanes-Cabus M, Teixido-Gimeno D, Diez-Garcia L, Pujol-Salud J, Evangelista-Robleda L, Bertran-Culla J, Ortega-Vila Y, Canal-Casals V, Siso-Almirall A. Ultrasound in primary care: Consensus recommendations on its applications and training. Results of a 3-round Delphi study. Eur J Gen Pract. 2022 Dec;28(1):253-259. doi: 10.1080/13814788.2022.2150163.
PubMed 36503353Homar V, Gale ZK, Lainscak M, Svab I. Knowledge and skills required to perform point-of-care ultrasonography in family practice - a modified Delphi study among family physicians in Slovenia. BMC Fam Pract. 2020 Mar 26;21(1):56. doi: 10.1186/s12875-020-01130-z.
PubMed 32216753Diaz-Gomez JL, Mayo PH, Koenig SJ. Point-of-Care Ultrasonography. N Engl J Med. 2021 Oct 21;385(17):1593-1602. doi: 10.1056/NEJMra1916062. No abstract available.
PubMed 34670045Andersen CA, Lundbye-Christensen S, Riis A, Mehnert U, Lokkegaard T, Mengel-Jorgensen T, Rasmussen LD, Soll N, Stork B, Andersen SK, Pil L, Stjernebjerg C, Graumann O, Jensen MB. General practitioners' scanning competence following tailored ultrasound training: a hybrid effectiveness-implementation study. BMC Med Educ. 2025 May 20;25(1):733. doi: 10.1186/s12909-025-07356-8.
PubMed 40394656von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. BMJ. 2007 Oct 20;335(7624):806-8. doi: 10.1136/bmj.39335.541782.AD.
PubMed 17947786Cascos E, Sitges M. The inevitable lightness of echocardioscopy: teamwork, training and quality assurance are indispensable. Rev Esp Cardiol (Engl Ed). 2023 Feb;76(2):83-85. doi: 10.1016/j.rec.2022.09.003. Epub 2022 Sep 19. No abstract available. English, Spanish.
PubMed 36245100Evangelista Robleda L. Utilidad de la ecoscopia realizada por un médico de familia en el diagnóstico de la enfermedad cardiovascular en atención primaria [doctoral thesis]. Barcelona: Universidad Autónoma de Barcelona; 2015. Available at: https://ddd.uab.cat/pub/tesis/2015/hdl_10803_328411/ler1de1.pdf
Bult MM, van de Ree TF, Wind AM, Hurley KM, van de Ree MA. The use of echocardiography compared to electrocardiogram when screening for left ventricular hypertrophy in hypertensive patients: A cross-sectional study. J Clin Hypertens (Greenwich). 2024 Aug;26(8):977-985. doi: 10.1111/jch.14867. Epub 2024 Jul 4.
PubMed 38963706Cheng S, He J, Han Y, Han S, Li P, Liao H, Guo J. Global burden of atrial fibrillation/atrial flutter and its attributable risk factors from 1990 to 2021. Europace. 2024 Jul 2;26(7):euae195. doi: 10.1093/europace/euae195.
PubMed 38984719Camm CF, Von Ende A, Gajendragadkar PR, Pessoa-Amorim G, Mafham M, Allen N, Parish S, Casadei B, Hopewell JC. Role of primary and secondary care data in atrial fibrillation ascertainment: impact on risk factor associations, patient management, and mortality in UK Biobank. Europace. 2025 Feb 5;27(2):euae291. doi: 10.1093/europace/euae291.
PubMed 39910980World Health Organization. Global burden of stroke [Internet]. [accessed 30-07-2024]. Available at: https://www.emro.who.int/health-topics/stroke-cerebrovascular-accident/index.html
King's College London, for the Stroke Alliance for Europe. The burden of stroke in Europe. Atrial fibrillation [Internet]. [consultat 1 gener 2024].