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

ConditionsAngina With Non-Obstructive Coronary Artery DiseaseCoronary Microvascular Dysfunction (CMD)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Christ Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Dapagliflozin ArmExperimental treatment 1 intervention
Group B: Placebo ArmPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
180 days

Secondary outcomes

1

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.

Time frame
180 days
2

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).

Time frame
180 days
3

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, %).

Time frame
180 Days
4

Epicardial Adipose Tissue (EAT) by Cardiac MRI

Total epicardial adipose tissue volume (mL) quantified from cardiac magnetic resonance imaging

Time frame
180 Days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Christ Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: