Angina With Non-Obstructive Coronary Artery DiseasePhase 2aDAPt-ANOCANCT07741890
aDAPt-ANOCA: Dapagliflozin for the Treatment of Angina With Non-Obstructive Coronary Artery Disease (ANOCA)
A Phase 2 study testing Dapagliflozin (10mg Tab) in people with Angina With Non-Obstructive Coronary Artery Disease and Coronary Microvascular Dysfunction (CMD), run by The Christ Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina With Non-Obstructive Coronary Artery Disease, Coronary Microvascular Dysfunction (CMD)
- What is being tested?
- Dapagliflozin (10mg Tab)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Mar 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Assistant Director, Regulatory and Compliance, MS contact
About this study
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.
- Conditions
- Angina With Non-Obstructive Coronary Artery Disease, Coronary Microvascular Dysfunction (CMD)
- Being tested
- Dapagliflozin (10mg Tab), Placebo ( FE)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin (10mg Tab)Drug
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 ( FE)Drug
Over encapsulated placebo to match active drug.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin Arm | Experimental | Randomized to dapaflagozin 10 mg once daily for 180 days Receives: Drug: Dapagliflozin (10mg Tab) |
| Placebo Arm | Placebo comparator | Randomized to placebo once daily for 180 days Receives: Drug: Placebo ( FE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quantitative myocardial perfusion reserve index (MPRI)
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.
Measured: 180 days
Secondary outcomes (19)
Tissue Characterization by Cardiac MRI
Change in native T1 relaxation time (ms), T2 relaxation time (ms) to quantify diffuse and focal myocardial fibrosis, edema, and tissue composition.
Measured: 180 days
Cardiac Structure and Function by Cardiac MRI
Change in left ventricular end-diastolic volume index (LVEDVi, mL/m²) and left ventricular end-systolic volume index (LVESVi, mL/m²).
Measured: 180 days
Cardiac Strain by Cardiac MRI
Change in segmental strain parameters by calculating the global longitudinal strain (GLS, %), global circumferential strain (GCS, %), global radial strain (GRS, %).
Measured: 180 Days
Epicardial Adipose Tissue (EAT) by Cardiac MRI
Total epicardial adipose tissue volume (mL) quantified from cardiac magnetic resonance imaging
Measured: 180 Days
Oxygen-sensitive cardiac magnetic resonance (OS-CMR)-derived BMORE biomarkers
Quantitative myocardial oxygenation and regional oxygen-sensitive signal intensity changes measured by OS-CMR to assess myocardial oxygenation reserve and coronary vascular function.
Measured: 180 days
Seattle Angina Questionnaire (SAQ)
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.
Measured: Baseline, 90 days, 180 days and 30 days after stopping treatment
6 minute walk test
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.
Measured: Baseline, 90 days, 180 days and post-drug assessment
Change in Bloodwork and Biomarkers Endothelial Dysfunction and Inflammation
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.
Measured: Baseline, 90 days, 180 days and 30 days after stopping treatment.
Change in Extracellular Volume Fraction (ECV) by Cardiac MRI
Change in extracellular volume fraction (ECV, %) measured by cardiovascular magnetic resonance (CMR) to quantify diffuse myocardial fibrosis and alterations in myocardial tissue composition.
Measured: 180 days
Cardiac Structure and Function by Cardiac MRI
Change in left ventricular mass index (LVMi, g/m²).
Measured: 180 days
Cardiac Structure and Function by Cardiac MRI
Change in relative wall thickness (RWT).
Measured: 180 days
Cardiac Structure and Function by Cardiac MRI
Change in left left ventricular ejection fraction (LVEF, %).
Measured: 180 days
Cardiac Structure and Function by Cardiac MRI
Change in estimated left ventricular filling pressures (E/e' ratio).
Measured: 180 days
Cardiac Strain by Cardiac MRI
Change in filling pressures (E/e' ratio).
Measured: 180 days
Duke Activity Status Index (DASI)
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.
Measured: Baseline, 90 days, 180 days and 30 days after stopping treatment
International Physical Activity Questionnaire (IPAQ)
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.
Measured: Baseline, 90 days, 180 days and 30 days after stopping treatment
The University of California, San Diego Shortness of Breath Questionnaire (UCSD-SOB)
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.
Measured: Baseline, 90 days, 180 days and 30 days after stopping treatment
Short Form-36 Health Survey (SF-36)
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.
Measured: Baseline, 90 days, 180 days and 30 days after stopping treatment
Change in Late Gadolinium Enhancement (LGE) by Cardiac MRI
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.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina With Non-Obstructive Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Christ Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Odayme Quesada, The Christ Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741890
- Sponsor's protocol ID
- 26-047
- Acronym
- aDAPt-ANOCA
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- aDAPt-ANOCA: Dapagliflozin for the Treatment of Angina With Non-Obstructive Coronary Artery Disease (ANOCA)
- ClinicalTrials.gov ID
- NCT07741890
- Acronym / sponsor ID
- aDAPt-ANOCA / 26-047
- Conditions
- Angina With Non-Obstructive Coronary Artery Disease, Coronary Microvascular Dysfunction (CMD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The Christ HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin Arm | Experimental | Drug: Dapagliflozin (10mg Tab)Randomized to dapaflagozin 10 mg once daily for 180 days |
| Placebo Arm | Placebo comparator | Drug: Placebo ( FE)Randomized to placebo once daily for 180 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Dapagliflozin Arm |
| Placebo ( FE)Over encapsulated placebo to match active drug. | Drug | Placebo Arm |
Primary outcome
Change in quantitative myocardial perfusion reserve index (MPRI)
Time frame: 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.
19 secondary outcomes
Tissue Characterization by Cardiac MRI
Time frame: 180 days
Cardiac Structure and Function by Cardiac MRI
Time frame: 180 days
Cardiac Strain by Cardiac MRI
Time frame: 180 Days
Epicardial Adipose Tissue (EAT) by Cardiac MRI
Time frame: 180 Days
Oxygen-sensitive cardiac magnetic resonance (OS-CMR)-derived BMORE biomarkers
Time frame: 180 days
Seattle Angina Questionnaire (SAQ)
Time frame: Baseline, 90 days, 180 days and 30 days after stopping treatment
6 minute walk test
Time frame: Baseline, 90 days, 180 days and post-drug assessment
Change in Bloodwork and Biomarkers Endothelial Dysfunction and Inflammation
Time frame: Baseline, 90 days, 180 days and 30 days after stopping treatment.
Change in Extracellular Volume Fraction (ECV) by Cardiac MRI
Time frame: 180 days
Cardiac Structure and Function by Cardiac MRI
Time frame: 180 days
Cardiac Structure and Function by Cardiac MRI
Time frame: 180 days
Cardiac Structure and Function by Cardiac MRI
Time frame: 180 days
Cardiac Structure and Function by Cardiac MRI
Time frame: 180 days
Cardiac Strain by Cardiac MRI
Time frame: 180 days
Duke Activity Status Index (DASI)
Time frame: Baseline, 90 days, 180 days and 30 days after stopping treatment
International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline, 90 days, 180 days and 30 days after stopping treatment
The University of California, San Diego Shortness of Breath Questionnaire (UCSD-SOB)
Time frame: Baseline, 90 days, 180 days and 30 days after stopping treatment
Short Form-36 Health Survey (SF-36)
Time frame: Baseline, 90 days, 180 days and 30 days after stopping treatment
Change in Late Gadolinium Enhancement (LGE) by Cardiac MRI
Time frame: 180 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Assistant Director, Regulatory and Compliance, MS contact
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dapagliflozin (10mg Tab) in people with Angina With Non-Obstructive Coronary Artery Disease and Coronary Microvascular Dysfunction (CMD), run by The Christ Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Assistant Director, Regulatory and Compliance, MS (15135851777, lindner_regulatory@thechristhospital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quantitative myocardial perfusion reserve index (MPRI) (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.