A Study of 68Ga-Fibroblast Activation Protein Inhibitor (FAPI) Positron Emission Tomography in Heart Failure

Официальное название

A Three-Arm, Observational, Pilot Study of 68Ga-Fibroblast Activation Protein Inhibitor (FAPI) Positron Emission Tomography in Heart Failure

Обзор

The purpose of this study is to assess the performance of 68Ga- FAPI PET in heart failure with preserved ejection fraction (HFpEF)

Вмешательства

• Препарат 68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor)
  68Ga-FAPI is a gallium-68 fibroblast activation protein inhibitor that will be injected into subjects during a PET (positron emission tomography) scan

Первичные конечные точки

• Myocardial 68Ga-FAPI (68Ga-Fibroblast Activation Protein Inhibitor) volume [Срок оценки: Baseline and 6 Months]
• Mean Standardized Uptake Value (SUVmean) and Max Standardized Uptake Value (SUVmax) [Срок оценки: Baseline and 6 Months]
• Area of 68Ga-FAPI (68Ga-Fibroblast Activation Protein Inhibitor) uptake [Срок оценки: Baseline and 6 Months]
• 68Ga-FAPI target-to-background ratio [Срок оценки: Baseline and 6 Months]

Критерии участия

HFpEF Group Inclusion:

• Patients aged ≥ 30 years old with exertional dyspnea (NYHA II and III) and LVEF ≥50%
• BMI ≥ 30
• New diagnosis of HFpEF based on RHC at baseline (elevated PCWP at rest and/or during exercise)

HFpEF Group Exclusion:

• Primary cardiomyopathy or pericardial disease or ≥ moderate valvular disease
• Dyspnea due to lung disease or CAD
• Severe anemia, liver, or renal disease
• Active cancer
• Systemic active inflammatory or autoimmune disease (e.g. rheumatoid arthritis, SLE, etc.)
• Recent hospitalization (< 30 days) or coronary revascularization (< 90 days)
• Patients already taking SGLT2i and/or GLP-1A
• Pregnant or breastfeeding
• Inability to tolerate supine position for the PET/CT or CMR scans.
• Contraindications for safe CMR scanning (e.g., uncontrolled claustrophobia, cochlear implant, implanted neural stimulator)
• Known gadolinium allergy
• Presence of implantable cardiac pacemaker or defibrillator or mechanical valve.

Cardiac Sarcoid Group Inclusion:

• Ambulatory patients aged ≥ 18 years old
• New referrals to the Sarcoid Clinic with a confirmed but untreated diagnosis of definite or probable CS based on 2014 HRS consensus (see Table 2)
• With a positive cardiac 18F-FDG PET scan within 30 days.

Cardiac Sarcoid Group Exclusion:

• Already on immunosuppressive therapy
• Pregnant or breastfeeding
• Severe liver or renal disease (estimated GFR < 30 or dialysis-dependent)
• Recent coronary revascularization (< 90 days)
• Active cancer
• Known gadolinium allergy
• Inability to tolerate supine position for the PET/CT or CMR scans.
• Contraindications for safe CMR scanning (e.g., uncontrolled claustrophobia, cochlear implant, implanted neural stimulator)
• Presence of implantable cardiac pacemaker or defibrillator or mechanical valve.

Healthy Controls Group Inclusion:

• Adults ≥ 30 years old
• No major chronic disease (cardiopulmonary, inflammatory, autoimmune, cancer, renal or liver impairment, etc.)
• No intake of relevant medication, defined as regular intake of at least one of the following: anticoagulants, antiplatelets, antihypertensive / diuretics, antidiabetics, antiarrhythmic, immunosuppressants, chemotherapy, antibiotics/antivirals/antifungals

Healthy Controls Group Exclusion:

• BMI ≥ 30
• Pregnant or breastfeeding
• Known gadolinium allergy
• Inability to tolerate supine position for the PET/CT or CMR scans.
• Contraindications for safe CMR scanning (e.g., uncontrolled claustrophobia, cochlear implant, implanted neural stimulator)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Mayo Clinic in Rochester — Rochester

Идентификаторы

NCT: NCT07083011 · 25-004043

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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