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

NCT07741890 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 26-047
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Angina With Non-Obstructive Coronary Artery Disease; Coronary Microvascular Dysfunction (CMD)

Outcome Measures

Primary Outcomes (1)

• 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.

  180 days

Secondary Outcomes (19)

• Tissue Characterization by Cardiac MRI

  180 days

• Cardiac Structure and Function by Cardiac MRI

  180 days

• Cardiac Strain by Cardiac MRI

  180 Days

• Epicardial Adipose Tissue (EAT) by Cardiac MRI

  180 Days

• Oxygen-sensitive cardiac magnetic resonance (OS-CMR)-derived BMORE biomarkers

  180 days

Study Arms (2)

Dapagliflozin Arm

EXPERIMENTAL

Randomized to dapaflagozin 10 mg once daily for 180 days

Drug: Dapagliflozin (10mg Tab)

Placebo Arm

PLACEBO COMPARATOR

Randomized to placebo once daily for 180 days

Drug: Placebo ( FE)

Interventions

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.

Dapagliflozin Arm

Placebo ( FE) DRUG

Over encapsulated placebo to match active drug.

Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Christ Hospital: lead

MeSH Terms

Interventions

dapagliflozin

Central Study Contacts

Assistant Director, Regulatory and Compliance, MS

CONTACT

15135851777; lindner_regulatory@thechristhospital.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: August 3, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: August 3, 2026

Record last verified: 2026-07