Myocardial FibrosisMY-FAPINCT07296081
⁶⁸Ga-FAPI PET/CT for Cardiac Fibrosis in Heart Failure
An observational study of Myocardial Fibrosis and Heart Failure, run by University of Coimbra at 1 site in Portugal.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Fibrosis, Heart Failure
- What is being tested?
- 68Ga-FAPI PET/CT
- How many people
- 30 participants
- Where
- 1 sitePortugal
- Study dates
- 17 Nov 2025to 31 Dec 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Fifteen patients with HFrEF (non-ischemic dilated cardiomyopathy) and Fifteen patients with HFpEF (hypertrophic cardiomyopathy)
Who may be able to join
- ≥ 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
Who cannot join
- 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;
Show all 12Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Faculdade de Medicina da Universidade de Coimbra
Coimbra, Coimbra District, 3000-548
João Borges Rosa, MD, +351239400400, joaopedroborgesrosa@gmail.com
About this study
Official title: Myocardial Fibrosis in Heart Failure: A Pilot Study With 68Ga-FAPI PET/CT
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.
Read more
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.
- Conditions
- Myocardial Fibrosis, Heart Failure
- Being tested
- 68Ga-FAPI PET/CT
- Keywords
- Fibroblast activation protein inhibitors, Gallium-68, Heart failure, Myocardial fibrosis, Positron emission tomography
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAPI PET/CTDiagnostic test
Positron emission tomography/computed tomography (68Ga-FAPI PET/CT)
| Study group | Role | What they receive |
|---|---|---|
| patients with HFrEF and HFpEF | patients with HFrEF (non-ischemic dilated cardiomyopathy) and HFpEF (hypertrophic cardiomyopathy) Receives: Diagnostic Test: 68Ga-FAPI PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
68Ga-FAPI uptake
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)
Measured: Baseline
Secondary outcomes (1)
68Ga-FAPI uptake
- 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.
Measured: Baseline (1 & 2) and after 2 years (3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start17 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial FibrosisStudies 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
- 30 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Collaborators
- Unidade Local de Saúde de Coimbra, EPE
- Responsible party
- Principal investigator, João Pedro Borges Rosa, University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296081
- Sponsor's protocol ID
- CE-113/2025
- Acronym
- MY-FAPI
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Fibrosis in Heart Failure: A Pilot Study With 68Ga-FAPI PET/CT
- ClinicalTrials.gov ID
- NCT07296081
- Acronym / sponsor ID
- MY-FAPI / CE-113/2025
- Conditions
- Myocardial Fibrosis, Heart Failure
- Keywords
- Fibroblast activation protein inhibitors, Gallium-68, Heart failure, Myocardial fibrosis, Positron emission tomography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Collaborators
- Unidade Local de Saúde de Coimbra, EPE
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with HFrEF and HFpEF | – | Diagnostic Test: 68Ga-FAPI PET/CTpatients with HFrEF (non-ischemic dilated cardiomyopathy) and HFpEF (hypertrophic cardiomyopathy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Fifteen patients with HFrEF (non-ischemic dilated cardiomyopathy) and Fifteen patients with HFpEF (hypertrophic cardiomyopathy)
Key inclusion criteria (6 listed)
- ≥ 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).
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-FAPI PET/CTPositron emission tomography/computed tomography (68Ga-FAPI PET/CT) | Diagnostic test | patients with HFrEF and HFpEF |
Primary outcome
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)
1 secondary outcome
68Ga-FAPI uptake
Time frame: Baseline (1 & 2) and after 2 years (3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Myocardial Fibrosis
Not yet recruitingObservational study
Native T1 Mapping and ECV in Chronic Hemolytic Anemia
Hemolytic Anemia, Thalassemia
Active, not recruitingObservational study
Mechanisms of Cardiac Dysfunction in HIV and the Effect of Statins: A Cardiac MRI Study
HIV Infections
Active, not recruitingObservational study
Atrial Late Gadolinium Enhancement in Patients With Repaired Congenital Heart Disease
Congenital Heart Disease, Fibrosis Myocardial
RecruitingPhase 4
Vericiguat and Reverse Remodeling Indices in Heart Failure
Heart Failure With Reduced Ejection Fraction (HFrEF), Chronic Heart Failure
RecruitingPhase 1
Phase IA and IB Study of AAVrh.10hFXN Gene Therapy for the Cardiomyopathy of Friedreich's Ataxia
Friedreich Ataxia, Cardiomyopathies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Fibrosis and Heart Failure, run by University of Coimbra at 1 site in Portugal.
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 6 inclusion and 12 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 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. 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 João Borges Rosa, MD (+351239400400, joaopedroborgesrosa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
68Ga-FAPI uptake (time frame: Baseline). 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 29 Dec 2025.