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NCT Number: NCT07296081

⁶⁸Ga-FAPI PET/CT for Cardiac Fibrosis in Heart Failure

Heart failure (HF) is a clinical syndrome with increasing incidence and prevalence, associated with high morbidity, mortality, and economic impact, despite therapeutic advances.

Myocardial fibrosis is a common feature across different pathophysiological processes and plays a key role in HF development, with growing research interest specifically in non-ischemic dilated cardiomyopathy (HFrEF phenotype) and hypertrophic cardiomyopathy (HFpEF phenotype). Given its potential reversibility with certain drugs, fibrosis is an attractive therapeutic target, requiring non-invasive methods to monitor fibrogenesis and treatment efficacy.

Cardiac magnetic resonance imaging (CMR) is the gold standard for detecting fibrosis but cannot distinguish between active and inactive fibrosis or detect early stages, limitations that may be addressed by gallium-68-labeled fibroblast activation protein inhibitor positron emission tomography/computed tomography (68Ga-FAPI PET/CT).

This single-center, prospective, observational pilot study aims primarily to assess myocardial fibrosis in patients with HFrEF (non-ischemic dilated cardiomyopathy) and a subtype of HFpEF (hypertrophic cardiomyopathy) using 68Ga-FAPI PET/CT compared to CMR.

Secondary objectives include developing 68Ga-FAPI uptake assessment methodologies for future anti-fibrotic therapy studies and correlating fibrosis with serum cardiac biomarkers and cardiovascular events.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculdade de Medicina da Universidade de Coimbra

Coimbra, Coimbra District, 3000-548, Portugal

Location status: Recruiting

Location contact

João Borges Rosa, MD

CONTACT

[email protected]

+351239400400

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 18 years old;
  • Signs and symptoms of heart failure (HF);
  • [Preserved left ventricular ejection fraction (LVEF) (≥50%) and Evidence of structural/functional abnormality consistent with diastolic dysfunction/increased ventricular filling pressures, including elevated natriuretic peptides and Imaging diagnosis of hypertrophic cardiomyopathy and Genetic diagnosis of hypertrophic cardiomyopathy due to sarcomeric gene mutation] OR [Reduced LVEF (≤40%) and Imaging diagnosis of dilated cardiomyopathy: left ventricular end-diastolic diameter >58 mm in men and >52 mm in women, and left ventricular volume ≥75 mL/m² in men and ≥62 mL/m² in women, not explained solely by loading conditions]
  • Recent transthoracic echocardiogram (< 3 months);
  • Recent cardiac magnetic resonance imaging (< 3 months).
  • Normal coronary angiogram or computed tomography coronary angiography within 6 months of enrolment

Exclusion criteria

  • Inability to provide informed consent;
  • Inability to tolerate the supine position;
  • Hemodynamic instability;
  • Claustrophobia;
  • Chronic kidney disease with glomerular filtration rate <30 mL/min/1.73m²;
  • Pregnant or breastfeeding women;
  • Malignant neoplasms within the past 5 years;
  • Significant primary valvular disease;
  • Significant atherosclerotic coronary artery disease;
  • Grade 2 or 3 arterial hypertension;
  • Presence of an implanted cardiac electrical device;
  • Recent hospitalization for heart failure (<30 days).

Treatment and study plan

68Ga-FAPI PET/CT

Diagnostic Test

Positron emission tomography/computed tomography (68Ga-FAPI PET/CT)

Primary outcomes

  1. 68Ga-FAPI uptake

    Time frame: Baseline

    Comparison of myocardial fibroblast activation identified by 68Ga-FAPI PET/CT with the non-invasive gold standard for fibrosis detection (Cardiac magnetic resonance with late gadolinium enhancement and extracellular volume)

Secondary outcomes

  1. 68Ga-FAPI uptake

    Time frame: Baseline (1 & 2) and after 2 years (3)

    • Identify suitable methodologies for assessing 68Ga-FAPI uptake for future studies evaluating the efficacy of anti-fibrotic therapies.
    • Correlate myocardial fibroblast activation identified by 68Ga-FAPI PET/CT with serum markers of cardiac pathology.
    • Correlate myocardial fibroblast activation identified by 68Ga-FAPI PET/CT with cardiovascular events over a 2-year follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

João Borges Rosa, MD

CONTACT

[email protected]

+351239400400

Sponsors and collaborators

Lead sponsor

University of Coimbra

Other

Collaborators

  • Unidade Local de Saúde de Coimbra, EPE

Registry information

Official study title

Myocardial Fibrosis in Heart Failure: A Pilot Study With 68Ga-FAPI PET/CT

Acronym: MY-FAPI

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Dec 22, 2025
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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