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Inhibidores del cotransportador de glucosa y sodio (SGLT) en la miocardiopatía hipertrófica no obstructiva (SOTA-CROSS HCM)

4 de noviembre de 2026 actualizado por: Sharlene Day, University of Pennsylvania

The goal of this clinical trial is to learn if sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, works to treat symptomatic, nonobstructive hypertrophic cardiomyopathy (noHCM) in adult patients. It will also learn about the safety of sotagliflozin in this patient population. The main questions it aims to answer are:

  1. Will sotagliflozin be well tolerated in patients with nonobstructive HCM?
  2. Will sotaglifozin improve exercise capacity, diastolic dysfunction and/or physical functioning in patients with nonobstructive HCM?
  3. Will sotagliflozin improve circulating markers of cardiac metabolism in patients with nonobstructive HCM?

Researchers will compare sotagliflozin to a placebo (a look-alike substance that contains no drug) to see if sotagliflozin is effective at treating hypertrophic cardiomyopathy (HCM).

Participants will:

Take sotagliflozin or a placebo every day for 12 weeks. They will then cross-over (or switch) to taking placebo or sotagliflozin (whichever one they did not take initially) for an additional 12 weeks.

Visit the clinic once every 4-12 weeks for checkups, surveys, and tests including a stress test and echocardiogram.

Descripción general del estudio

Estado

Activo, no reclutando

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

26

Fase

  • Fase temprana 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • University of Pennsylvania

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Age at least 18 years, both sexes
  2. Provision of signed and dated informed consent form
  3. Stated willingness to comply with all study procedures and availability for the duration of the study
  4. Ability to take oral medication and be willing to adhere to the study intervention.
  5. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 2 weeks after the end of administration of study drug.
  6. Diagnosis of HCM with NYHA Class II-III functional class or New York Heart Association (NYHA) Class I with peak VO2 < 90% on cardiopulmonary exercise stress testing performed at Visit 1.
  7. Left ventricular outflow tract gradient < 50 mmHg at rest, with valsalva, and with exercise.

7. Left ventricular ejection fraction > 50% by echocardiogram or cardiac MRI based on the most recent assessment in the past year prior to screening and confirmed during Visit 1 echocardiogram.

8. Stable medical therapy for at least 1 month prior to study enrollment.

Exclusion Criteria:

  1. Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrollment or previous intolerance of an SGLT2 inhibitor
  2. Type 1 diabetes mellitus
  3. Age <18 years old
  4. Pregnant or lactating women: Women of childbearing potential will undergo a urine pregnancy test during the screening visit.
  5. Uncontrolled atrial fibrillation, as defined by a resting heart rate > 100 beats per minute at the time of the baseline assessment
  6. Paroxysmal atrial fibrillation (Afib) or flutter with plans to attempt to restore sinus rhythm (with drug therapy, ablation, or DC cardioversion) during the study period.
  7. Unable to attain a respiratory exchange ratio of at least 1.05 on cardiopulmonary exercise test (CPET) on the day of screening.
  8. Septal reduction therapy within the previous 3 months.
  9. Implantable cardio-defibrillator (ICD) implantation planned during the study period.
  10. Implantation of a cardiac resynchronization therapy (CRT) device within 12 weeks prior to enrollment or intent to implant a CRT device during the study period
  11. Hemoglobin < 10 g/dL
  12. Estimated glomerular filtration rate (eGFR) < 25 mL/min/1.73m^2, or unstable or rapidly progressing renal disease at the time of randomization
  13. Subject inability/unwillingness to exercise
  14. Greater than moderate left sided valvular disease (mitral regurgitation, aortic stenosis, aortic regurgitation), moderate or greater mitral stenosis, or severe right-sided valvular disease based on baseline echo at the time of enrollment
  15. Current angina due to clinically significant epicardial coronary disease, as per investigator judgment
  16. Acute coronary syndrome or coronary intervention within the past 2 months
  17. Primary pulmonary artery hypertension (WHO Group 1 Pulmonary Arterial Hypertension)
  18. Clinically significant lung disease as defined by: Chronic Obstructive Pulmonary Disease meeting Stage III or greater GOLD criteria (FEV1<50% predicted), treatment with oral steroids within the past 6 months for an exacerbation of obstructive lung disease, or current use of supplemental oxygen aside from nocturnal oxygen for the treatment of obstructive sleep apnea.
  19. Clinically-significant ischemia, as per investigator's judgement, on stress testing without either (1) subsequent revascularization, (2) an angiogram demonstrating the absence of clinically significant epicardial coronary artery disease, as per investigator judgment; (3) a follow-up 'negative' stress test, particularly when using a more specific technique (i.e., a negative perfusion imaging test following a 'positive' ECG stress test)
  20. Symptomatic bradycardia or second- or third-degree heart block, in the absence of a pacemaker
  21. Significant liver disease impacting synthetic function or volume control (ALT/AST > 3x ULN, Albumin < 3.0 g/dL)
  22. Severe right ventricular dysfunction on baseline echocardiogram
  23. Orthostatic blood pressure response to the transition from supine to standing (>20 mmHg reduction in systolic blood pressure 2-3 minutes after standing)
  24. Active participation in another study that utilizes an investigational agent (observational studies/registries allowed)
  25. Any condition that, in the opinion of the investigator, will interfere with the completion of the study. This may include comorbid or psychiatric conditions that may impede successful completion of the protocol, or logistical concerns (e.g. inability to travel to the exercise unit).

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: Placebo first phase, Sotagliflozin second phase

Matching placebo once daily will be administered in the first phase, Sotagliflozin 400 mg once daily will be administered in the second phase

Sotagliflozin or placebo will be administered to each participant in a cross over study design. Each participant will receive active drug and placebo with randomization of the order in which they receive them.

Otros nombres:
  • Inpefa
Comparador activo: Sotagliflozin first phase, Placebo second phase

Sotagliflozin 400 mg once daily will be administered in the first phase, matching placebo once daily will be administered in the second phase

Sotagliflozin or placebo will be administered to each participant in a cross over study design. Each participant will receive active drug and placebo with randomization of the order in which they receive them.

Otros nombres:
  • Inpefa

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of participants with treatment-related adverse events
Periodo de tiempo: Through study completion, 28 weeks

Adverse event reporting

Through study completion, 28 weeks
Intracavitary obstruction
Periodo de tiempo: Through study completion, 28 weeks

Intracavitary left ventricular pressure gradient in mmHg

Through study completion, 28 weeks
Cardiac rhythm
Periodo de tiempo: Through study completion, 28 weeks

New occurrence of cardiac arrhythmia measured by ambulatory monitoring

Through study completion, 28 weeks
Maximal exercise capacity
Periodo de tiempo: Through study completion, 28 weeks

Peak oxygen consumption in mL/min

Through study completion, 28 weeks
Submaximal exercise capacity
Periodo de tiempo: Through study completion, 28 weeks

Stroke volume augmentation at exercise steady state in mL/min

Through study completion, 28 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Systolic function
Periodo de tiempo: Through study completion, 28 weeks

Left ventricular ejection fraction in % measured by echocardiography

Through study completion, 28 weeks
Contractility
Periodo de tiempo: Through study completion, 28 weeks

Global longitudinal strain in % measured by echocardiography

Through study completion, 28 weeks
Diastolic function
Periodo de tiempo: Through study completion, 28 weeks

E/E' ratio measured by echocardiography

Through study completion, 28 weeks
Left ventricular hypertrophy
Periodo de tiempo: Through study completion, 28 weeks

Maximal left ventricular wall thickness in mm by echocardiography

Through study completion, 28 weeks
Symptom scores
Periodo de tiempo: Through study completion, 28 weeks

Kansas City Living with Heart Failure (KCCQ) Clinical Summary Score, scale 0-100 with lower scores being worse

Through study completion, 28 weeks
Symptom scores and quality of life
Periodo de tiempo: Through study completion, 28 weeks

Kansas City Living with Heart Failure (KCCQ) Overall Summary Score, score 0-100 with lower scores being worse

Through study completion, 28 weeks
Biomarkers
Periodo de tiempo: Through study completion, 28 weeks

Serum levels of N-terminal-proBNP

Through study completion, 28 weeks
Circulating metabolites
Periodo de tiempo: Through study completion, 28 weeks

Concentration of serum metabolites

Through study completion, 28 weeks
Measurement of periods of activity and rest
Periodo de tiempo: Through study completion, 28 weeks

Daily step counts by actigraphy

Through study completion, 28 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Sharlene Day, MD, University of Pennsylvania

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

17 de diciembre de 2024

Finalización primaria (Estimado)

1 de mayo de 2027

Finalización del estudio (Estimado)

1 de junio de 2027

Fechas de registro del estudio

Enviado por primera vez

13 de mayo de 2024

Primero enviado que cumplió con los criterios de control de calidad

22 de mayo de 2024

Publicado por primera vez (Actual)

29 de mayo de 2024

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

4 de noviembre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 855065
  • R61HL164376 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

No individual participant data will be available to other researchers

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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