aDAPt-ANOCA: Dapagliflozin for the Treatment of Angina With Non-Obstructive Coronary Artery Disease (ANOCA) (aDAPt-ANOCA)
28. juli 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
120
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Assistant Director, Regulatory and Compliance, MS
- Telefonnummer: 15135851777
- E-post: lindner_regulatory@thechristhospital.com
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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:
- 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
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Dapagliflozin Arm
Randomized to dapaflagozin 10 mg once daily for 180 days
|
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.
|
|
Placebo komparator: Placebo Arm
Randomized to placebo once daily for 180 days
|
Over encapsulated placebo to match active drug.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in quantitative myocardial perfusion reserve index (MPRI)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Tissue Characterization by Cardiac MRI
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 180 days
|
Change in left ventricular mass index (LVMi, g/m²).
|
180 days
|
|
Cardiac Structure and Function by Cardiac MRI
Tidsramme: 180 days
|
Change in relative wall thickness (RWT).
|
180 days
|
|
Cardiac Structure and Function by Cardiac MRI
Tidsramme: 180 days
|
Change in left left ventricular ejection fraction (LVEF, %).
|
180 days
|
|
Cardiac Structure and Function by Cardiac MRI
Tidsramme: 180 days
|
Change in estimated left ventricular filling pressures (E/e' ratio).
|
180 days
|
|
Cardiac Strain by Cardiac MRI
Tidsramme: 180 days
|
Change in filling pressures (E/e' ratio).
|
180 days
|
|
Duke Activity Status Index (DASI)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
|
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Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
1. desember 2028
Studiet fullført (Antatt)
1. mars 2029
Datoer for studieregistrering
Først innsendt
20. juli 2026
Først innsendt som oppfylte QC-kriteriene
28. juli 2026
Først lagt ut (Faktiske)
3. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 26-047
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