aDAPt-ANOCA: Dapagliflozin for the Treatment of Angina With Non-Obstructive Coronary Artery Disease (ANOCA)

Korábbi kezelés

• Current treatment with any SGLT-2 inhibitor
• Pre-menopausal women (last menstruation ≤ 1 year prior to informed consent) who: - are nursing or pregnant or - are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence (if allowed by local Authorities), double barrier method and vasectomized partner.
• Contraindications to CMRI such as ferromagnetic implants and materials, Cochlear implants, implanted neurostimulators, severe obesity, and certain cerebral aneurysm clips, severe claustrophobia.
• Currently enrolled in another investigational device or drug trial, or less than 30 days since ending another investigational device or drug trial(s) or receiving other investigational treatment(s). Patients participating in a purely observational trial will not be excluded

Más betegség

• Clinical Diagnosis Type 1 or 2 diabetes on medical treatment
• Symptomatic Postural Orthostatic Tachycardia Syndrome (POTS)
• History of coronary artery bypass graft (CABG)
• Severe valvular heart disease (any valve)
• Cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, cardiomyopathy with reversible causes (e.g. stress cardiomyopathy), hypertrophic obstructive cardiomyopathy or known pericardial constriction
• Hypersensitivity to SGLT2i
• History of genital mycotic infections
• History of chronic urinary tract infections (UTIs)
• Any clinical condition that might interfere with the trial protocol or the Participant's ability to be compliant with the trial protocol (e.g., active alcohol or drug abuse, dementia).
• Any other condition which, in the opinion of the investigator, may preclude the participant from safe participation in the study or compromise data integrity

Laborértékek

• Clinical Diagnosis of Heart failure with preserved ejection fraction (HFpEF)
• Impaired renal function (eGFR less than 30 mL/min/1.73 m2)

Egyéb

• BMI > 35 kg/m²
• Symptomatic hypotension
• Comorbidities limiting life expectancy to less than one year

• Participant is older than 18 years of age
• Participant is willing and able to sign informed consent
• Participant is willing to comply with the specified follow-up evaluations
• Anginal Symptoms (chest pain, pressure, dyspnea on exertion, or anginal equivalents
• Stable CMD treatment (ie: Guideline Directed Medical Treatment) for >30 days prior to enrollment with no plans to change treatment during trial duration
• Non-obstructive CAD: Patients with non-obstructive CAD (coronary narrowing of <50%, and/or FFR ≥0.80) assessed by Left Heart Cath or CCTA within the past 5 years
• Diagnosis of CMD based on prior testing within 5 years:
  • Invasive Coronary Functional Testing derived Coronary Flow Reserve (CFR) < 2.5
  • Stress Cardiac MRI measure myocardial perfusion reserve index (MPRI) <2.5
  • Stress Positron Emission Tomography (PET) measured Myocardial Blood Flow <2.5