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

Обзор

The primary purpose of this study is to evaluate the efficacy of DAPA for the treatment of coronary microvascular dysfunction (CMD) among patients with angina and no obstructive coronary artery disease (ANOCA) and established CMD as compared to placebo.

Вмешательства

• Препарат Dapagliflozin (10mg Tab)
  The study will be double blinded by over encapsulation of Dapagliflozin with a matching lactose powder capsule used for the placebo group. All enrolled participants who meet inclusion / exclusion will receive either 10 mg Dapagliflozin (10mg) for 180 days, or placebo, randomized 1:1.
• Препарат Placebo ( FE)
  Over encapsulated placebo to match active drug.

Первичные конечные точки

• Change in quantitative myocardial perfusion reserve index (MPRI) [Срок оценки: 180 days]

Вторичные конечные точки (12)

• Tissue Characterization by Cardiac MRI [Срок оценки: 180 days]
• Cardiac Structure and Function by Cardiac MRI [Срок оценки: 180 days]
• Cardiac Strain by Cardiac MRI [Срок оценки: 180 Days]
• Epicardial Adipose Tissue (EAT) by Cardiac MRI [Срок оценки: 180 Days]
• Oxygen-sensitive cardiac magnetic resonance (OS-CMR)-derived BMORE biomarkers [Срок оценки: 180 days]
• Seattle Angina Questionnaire (SAQ) [Срок оценки: Baseline, 90 days, 180 days and 30 days after stopping treatment]
• 6 minute walk test [Срок оценки: Baseline, 90 days, 180 days and post-drug assessment]
• Change in Bloodwork and Biomarkers Endothelial Dysfunction and Inflammation [Срок оценки: Baseline, 90 days, 180 days and 30 days after stopping treatment.]
• Change in Extracellular Volume Fraction (ECV) by Cardiac MRI [Срок оценки: 180 days]
• Cardiac Structure and Function by Cardiac MRI [Срок оценки: 180 days]
• Cardiac Structure and Function by Cardiac MRI [Срок оценки: 180 days]
• Cardiac Structure and Function by Cardiac MRI [Срок оценки: 180 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Clinical Diagnosis Type 1 or 2 diabetes on medical treatment
• Clinical Diagnosis of Heart failure with preserved ejection fraction (HFpEF)
• Symptomatic Postural Orthostatic Tachycardia Syndrome (POTS)
• History of coronary artery bypass graft (CABG)
• Severe valvular heart disease (any valve)
• BMI > 35 kg/m²
• 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
• Current treatment with any SGLT-2 inhibitor
• Hypersensitivity to SGLT2i
• Impaired renal function (eGFR less than 30 mL/min/1.73 m2)
• Symptomatic hypotension
• History of genital mycotic infections
• History of chronic urinary tract infections (UTIs)
• 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.
• Comorbidities limiting life expectancy to less than one year
• 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).
• 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
• Any other condition which, in the opinion of the investigator, may preclude the participant from safe participation in the study or compromise data integrity

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07741890 · 26-047

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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