aDAPt-ANOCA: Dapagliflozin for the Treatment of Angina With Non-Obstructive Coronary Artery Disease (ANOCA) (aDAPt-ANOCA)
2026年7月28日 更新者：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.
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
120
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Assistant Director, Regulatory and Compliance, MS
- 電話番号：15135851777
- メール：lindner_regulatory@thechristhospital.com
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
|
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プラセボコンパレーター：Placebo Arm
Randomized to placebo once daily for 180 days
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Over encapsulated placebo to match active drug.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in quantitative myocardial perfusion reserve index (MPRI)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Tissue Characterization by Cardiac MRI
時間枠：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
時間枠：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
時間枠：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
時間枠：180 Days
|
Total epicardial adipose tissue volume (mL) quantified from cardiac magnetic resonance imaging
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180 Days
|
|
Oxygen-sensitive cardiac magnetic resonance (OS-CMR)-derived BMORE biomarkers
時間枠：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)
時間枠：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.
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Baseline, 90 days, 180 days and 30 days after stopping treatment
|
|
6 minute walk test
時間枠：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.
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Baseline, 90 days, 180 days and post-drug assessment
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Change in Bloodwork and Biomarkers Endothelial Dysfunction and Inflammation
時間枠：Baseline, 90 days, 180 days and 30 days after stopping treatment.
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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.
|
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Change in Extracellular Volume Fraction (ECV) by Cardiac MRI
時間枠：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
時間枠：180 days
|
Change in left ventricular mass index (LVMi, g/m²).
|
180 days
|
|
Cardiac Structure and Function by Cardiac MRI
時間枠：180 days
|
Change in relative wall thickness (RWT).
|
180 days
|
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Cardiac Structure and Function by Cardiac MRI
時間枠：180 days
|
Change in left left ventricular ejection fraction (LVEF, %).
|
180 days
|
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Cardiac Structure and Function by Cardiac MRI
時間枠：180 days
|
Change in estimated left ventricular filling pressures (E/e' ratio).
|
180 days
|
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Cardiac Strain by Cardiac MRI
時間枠：180 days
|
Change in filling pressures (E/e' ratio).
|
180 days
|
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Duke Activity Status Index (DASI)
時間枠：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.
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Baseline, 90 days, 180 days and 30 days after stopping treatment
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International Physical Activity Questionnaire (IPAQ)
時間枠：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.
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Baseline, 90 days, 180 days and 30 days after stopping treatment
|
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The University of California, San Diego Shortness of Breath Questionnaire (UCSD-SOB)
時間枠：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.
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Baseline, 90 days, 180 days and 30 days after stopping treatment
|
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Short Form-36 Health Survey (SF-36)
時間枠：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.
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Baseline, 90 days, 180 days and 30 days after stopping treatment
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Change in Late Gadolinium Enhancement (LGE) by Cardiac MRI
時間枠：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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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月1日
一次修了 (推定)
2028年12月1日
研究の完了 (推定)
2029年3月1日
試験登録日
最初に提出
2026年7月20日
QC基準を満たした最初の提出物
2026年7月28日
最初の投稿 (実際)
2026年8月3日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月3日
QC基準を満たした最後の更新が送信されました
2026年7月28日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 26-047
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
はい
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