aDAPt-ANOCA: Dapagliflozin for the Treatment of Angina With Non-Obstructive Coronary Artery Disease (ANOCA) (aDAPt-ANOCA)
28 de julho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
120
Estágio
- Fase 2
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Assistant Director, Regulatory and Compliance, MS
- Número de telefone: 15135851777
- E-mail: lindner_regulatory@thechristhospital.com
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
|
|
Comparador de Placebo: Placebo Arm
Randomized to placebo once daily for 180 days
|
Over encapsulated placebo to match active drug.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in quantitative myocardial perfusion reserve index (MPRI)
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Tissue Characterization by Cardiac MRI
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 180 days
|
Change in left ventricular mass index (LVMi, g/m²).
|
180 days
|
|
Cardiac Structure and Function by Cardiac MRI
Prazo: 180 days
|
Change in relative wall thickness (RWT).
|
180 days
|
|
Cardiac Structure and Function by Cardiac MRI
Prazo: 180 days
|
Change in left left ventricular ejection fraction (LVEF, %).
|
180 days
|
|
Cardiac Structure and Function by Cardiac MRI
Prazo: 180 days
|
Change in estimated left ventricular filling pressures (E/e' ratio).
|
180 days
|
|
Cardiac Strain by Cardiac MRI
Prazo: 180 days
|
Change in filling pressures (E/e' ratio).
|
180 days
|
|
Duke Activity Status Index (DASI)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
|
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Change in Late Gadolinium Enhancement (LGE) by Cardiac MRI
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de setembro de 2026
Conclusão Primária (Estimado)
1 de dezembro de 2028
Conclusão do estudo (Estimado)
1 de março de 2029
Datas de inscrição no estudo
Enviado pela primeira vez
20 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
28 de julho de 2026
Primeira postagem (Real)
3 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
3 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
28 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 26-047
Plano para dados de participantes individuais (IPD)
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