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

28 lipca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

120

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Dapagliflozin Arm
Randomized to dapaflagozin 10 mg once daily for 180 days
Lek: 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.
Komparator placebo: Placebo Arm
Randomized to placebo once daily for 180 days
Lek: Placebo ( FE)
Over encapsulated placebo to match active drug.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in quantitative myocardial perfusion reserve index (MPRI)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Tissue Characterization by Cardiac MRI
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 180 days
Change in left ventricular mass index (LVMi, g/m²).
180 days
Cardiac Structure and Function by Cardiac MRI
Ramy czasowe: 180 days
Change in relative wall thickness (RWT).
180 days
Cardiac Structure and Function by Cardiac MRI
Ramy czasowe: 180 days
Change in left left ventricular ejection fraction (LVEF, %).
180 days
Cardiac Structure and Function by Cardiac MRI
Ramy czasowe: 180 days
Change in estimated left ventricular filling pressures (E/e' ratio).
180 days
Cardiac Strain by Cardiac MRI
Ramy czasowe: 180 days
Change in filling pressures (E/e' ratio).
180 days
Duke Activity Status Index (DASI)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

The Christ Hospital

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 września 2026

Zakończenie podstawowe (Szacowany)

1 grudnia 2028

Ukończenie studiów (Szacowany)

1 marca 2029

Daty rejestracji na studia

Pierwszy przesłany

20 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

28 lipca 2026

Pierwszy wysłany (Rzeczywisty)

3 sierpnia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

3 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

28 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 26-047

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Tak

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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