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

28 juillet 2026 mis à jour par: Odayme Quesada, The Christ Hospital
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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

120

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • 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:

    1. Invasive Coronary Functional Testing derived Coronary Flow Reserve (CFR) < 2.5
    2. Stress Cardiac MRI measure myocardial perfusion reserve index (MPRI) <2.5
    3. Stress Positron Emission Tomography (PET) measured Myocardial Blood Flow <2.5

Exclusion Criteria:

  • 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Dapagliflozin Arm
Randomized to dapaflagozin 10 mg once daily for 180 days
Médicament: 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.
Comparateur placebo: Placebo Arm
Randomized to placebo once daily for 180 days
Médicament: Placebo ( FE)
Over encapsulated placebo to match active drug.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in quantitative myocardial perfusion reserve index (MPRI)
Délai: 180 days
Change from baseline in the dapagliflozin group compared with the placebo group. A normal MPRI value is usually above 2.0. A value below 1.5 often points to reduced blood flow or poor heart function.
180 days

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Tissue Characterization by Cardiac MRI
Délai: 180 days
Change in native T1 relaxation time (ms), T2 relaxation time (ms) to quantify diffuse and focal myocardial fibrosis, edema, and tissue composition.
180 days
Cardiac Structure and Function by Cardiac MRI
Délai: 180 days
Change in left ventricular end-diastolic volume index (LVEDVi, mL/m²) and left ventricular end-systolic volume index (LVESVi, mL/m²).
180 days
Cardiac Strain by Cardiac MRI
Délai: 180 Days
Change in segmental strain parameters by calculating the global longitudinal strain (GLS, %), global circumferential strain (GCS, %), global radial strain (GRS, %).
180 Days
Epicardial Adipose Tissue (EAT) by Cardiac MRI
Délai: 180 Days
Total epicardial adipose tissue volume (mL) quantified from cardiac magnetic resonance imaging
180 Days
Oxygen-sensitive cardiac magnetic resonance (OS-CMR)-derived BMORE biomarkers
Délai: 180 days
Quantitative myocardial oxygenation and regional oxygen-sensitive signal intensity changes measured by OS-CMR to assess myocardial oxygenation reserve and coronary vascular function.
180 days
Seattle Angina Questionnaire (SAQ)
Délai: Baseline, 90 days, 180 days and 30 days after stopping treatment
The Seattle Angina Questionnaire (SAQ) is a validated, disease-specific instrument designed to measure the impact of angina on patients' health status and quality of life. The questionnaire assesses five domains: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease-specific quality of life. Scores range from 0 to 100, with higher scores indicating better health status and fewer angina-related limitations.
Baseline, 90 days, 180 days and 30 days after stopping treatment
6 minute walk test
Délai: Baseline, 90 days, 180 days and post-drug assessment
Change in total distance walked in 6 minutes (meters), along with pre- and post-test measurements of oxygen saturation (SpO₂), heart rate, perceived exertion (Borg Rating of Perceived Exertion), and symptoms (e.g., dyspnea and fatigue). All parameters are combined to measure functional capacity.
Baseline, 90 days, 180 days and post-drug assessment
Change in Bloodwork and Biomarkers Endothelial Dysfunction and Inflammation
Délai: Baseline, 90 days, 180 days and 30 days after stopping treatment.
Change in CBC, HbA1c, insulin resistance measures, iron studies, lipid profile, serum ketones, EPO levels, and NT-proBNP concentrations measured to evaluate systemic inflammation, endothelial dysfunction, metabolic health, and cardiovascular status.
Baseline, 90 days, 180 days and 30 days after stopping treatment.
Change in Extracellular Volume Fraction (ECV) by Cardiac MRI
Délai: 180 days
Change in extracellular volume fraction (ECV, %) measured by cardiovascular magnetic resonance (CMR) to quantify diffuse myocardial fibrosis and alterations in myocardial tissue composition.
180 days
Cardiac Structure and Function by Cardiac MRI
Délai: 180 days
Change in left ventricular mass index (LVMi, g/m²).
180 days
Cardiac Structure and Function by Cardiac MRI
Délai: 180 days
Change in relative wall thickness (RWT).
180 days
Cardiac Structure and Function by Cardiac MRI
Délai: 180 days
Change in left left ventricular ejection fraction (LVEF, %).
180 days
Cardiac Structure and Function by Cardiac MRI
Délai: 180 days
Change in estimated left ventricular filling pressures (E/e' ratio).
180 days
Cardiac Strain by Cardiac MRI
Délai: 180 days
Change in filling pressures (E/e' ratio).
180 days
Duke Activity Status Index (DASI)
Délai: Baseline, 90 days, 180 days and 30 days after stopping treatment
The Duke Activity Status Index (DASI) is a validated 12-item self-administered questionnaire that evaluates functional capacity by assessing a participant's ability to perform common activities of daily living requiring varying levels of physical exertion. Responses are used to calculate a weighted score that correlates with peak oxygen uptake (VO₂ peak) and functional exercise capacity. The DASI provides a practical estimate of cardiovascular functional status and has been extensively validated in patients with ischemic heart disease and heart failure. Scores range from 0 to 58.2, with higher scores indicated improved function.
Baseline, 90 days, 180 days and 30 days after stopping treatment
International Physical Activity Questionnaire (IPAQ)
Délai: Baseline, 90 days, 180 days and 30 days after stopping treatment
The International Physical Activity Questionnaire (IPAQ) is a standardized, validated instrument used to quantify habitual physical activity over the previous seven days. The questionnaire assesses the frequency and duration of walking, moderate-intensity activity, vigorous-intensity activity, and sedentary behavior across work, transportation, household, and leisure domains. IPAQ results will be used to characterize participants' baseline activity levels and evaluate changes in physical activity during the intervention period. Scores are calculated as weekly metabolic equivalents beginning with 0 to 3000+ METs with higher METS indicating increased physical activity.
Baseline, 90 days, 180 days and 30 days after stopping treatment
The University of California, San Diego Shortness of Breath Questionnaire (UCSD-SOB)
Délai: Baseline, 90 days, 180 days and 30 days after stopping treatment
UCSD-SOB is a validated patient-reported outcome measure designed to quantify dyspnea during activities of daily living. The questionnaire evaluates the severity of shortness of breath across a broad range of physical activities and includes items assessing limitations due to breathlessness. Scores range from 0 to 120 with higher scores indicating worse dyspnea.
Baseline, 90 days, 180 days and 30 days after stopping treatment
Short Form-36 Health Survey (SF-36)
Délai: Baseline, 90 days, 180 days and 30 days after stopping treatment
The 36-Item Short Form Health Survey (SF-36) is a widely validated generic measure of health-related quality of life. The questionnaire evaluates eight health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional health, and mental health. Domain scores are summarized into Physical Component Summary (PCS) and Mental Component Summary (MCS) scores, providing a comprehensive assessment of overall health status. The SF-36 is designed to detect changes in both physical and psychosocial well-being over time and allows comparison with other disease populations and the general population. Scores on the SF-36 range from 0 to 100 with increased scores representing better health in that domain.
Baseline, 90 days, 180 days and 30 days after stopping treatment
Change in Late Gadolinium Enhancement (LGE) by Cardiac MRI
Délai: 180 days
Change in late gadolinium enhancement (LGE, % of left ventricular mass) measured by cardiovascular magnetic resonance (CMR) to quantify focal myocardial fibrosis and myocardial scar burden.
180 days

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

The Christ Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

1 décembre 2028

Achèvement de l'étude (Estimé)

1 mars 2029

Dates d'inscription aux études

Première soumission

20 juillet 2026

Première soumission répondant aux critères de contrôle qualité

28 juillet 2026

Première publication (Réel)

3 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 26-047

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Oui

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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