The Effect of Additive On-Demand Sildenafil vs. Dextrose Candy on Maximum Exercise Capacity in Pulmonary Arterial Hypertension (Pocket-PH)
12 de septiembre de 2026 actualizado por: Silvia Ulrich
The Effect of Additive On-Demand Sildenafil vs. Dextrose Candy on Maximum Exercise Capacity in Pulmonary Arterial Hypertension: A Randomized, Cross-Over Trial.
The goal of this clinical study is to investigate whether the additional intake of sildenafil 20mg on top of standard medical treatment results in a benefit on maximum exercise workload (Wmax) in patients with pulmonary arterial hypertension (PAH).
Descripción general del estudio
Estado
Reclutamiento
Intervención / Tratamiento
Descripción detallada
This study is a prospective, randomized, cross-over trial evaluating the effects of additive 20 mg sildenafil versus placebo/sham dextrose candy on exercise capacity in patients with previously diagnosed pulmonary arterial hypertension (PAH).
PAH is a progressive and debilitating disease characterized by increased mean pulmonary arterial pressure (mPAP) and pulmonary vascular resistance (PVR), leading to right ventricular overload, and ultimately right heart failure. Despite advancements in pharmacological therapy, treatment options remain limited and optimizing individualized approaches to improve exercise capacity and manage symptom burden remains a challenge.
Phosphodiesterase type 5 inhibitors, such as sildenafil, are cornerstones of PAH treatment, enhancing pulmonary vasodilation and improving haemodynamics. While three times daily dosing is standard with three time 20-80mg daily. On-demand additive sildenafil use before exercise has not been studied, but as recent trials have shown that dosing up to three times 80mg is as safe as 20mg, there is a potential that additive therapy may be beneficial. Given sildenafil's rapid onset of action with peak effects after 30-120 minutes, it may offer acute functional benefits regarding maximum workload (Wmax) when administered shortly beforehand, in the terms of a "pill-in-the pocket" intake.
After providing informed consent, eligible participants (aged 18 - 80 years, with PAH diagnosed according to the ESC/ERS 2022/2019 guidelines) will be randomly assigned to receive either 20 mg sildenafil or dextrose candy (Dextro Energy). 45 minutes post-intake, they will undergo incremental spiroergometry (10-20 W increases) and right heart focused stress-echocardiography on a cycle ergometer until exhaustion. After a rest phase of 30 minutes, patients will perform CWRET at 75% of achieved Wmax until exhaustion. Then, after a washout period of minimum 24 hours up to 12 weeks, participants will cross over to the opposite treatment, repeating the same protocol.
In case of a beneficial result, our study could support the use of an additive pill-in-the-pocket therapy strategy which may allow treatment to be tailored to the individual activity demands of patients.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
20
Fase
- Fase 2
- Fase 3
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.
Estudio Contacto
- Nombre: Arcangelo F Carta, MD
- Número de teléfono: +41 44 255 22 20
- Correo electrónico: arcangelo.carta@usz.ch
Copia de seguridad de contactos de estudio
- Nombre: Silvia Ulrich, Prof. MD
- Número de teléfono: +41 44 255 22 21
- Correo electrónico: silvia.ulrich@usz.ch
Ubicaciones de estudio
-
-
Canton of Zurich
-
Zurich, Canton of Zurich, Suiza, 8091
- Reclutamiento
- University Hospital of Zurich, Department of Pulmonology
-
Contacto:
- Arcangelo F Carta, Dr. med.
- Número de teléfono: +41 44 255 22 20
- Correo electrónico: arcangelo.carta@usz.ch
-
-
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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Signed Informed consent
- Age 18 - 80 years (both sexes)
- Pulmonary hypertension (PH) class I (PAH) previously diagnosed according to ESC/ERS 2022/2019 guidelines (mPAP ≥ 20 mmHg, PVR ≥ 2 WU, PAWP ≤ 15 mmHg) during diagnostic right-heart catheterization.
- Stable condition, on the same PH-medication for >4 weeks
Exclusion Criteria:
- Severe resting hypoxia (PaO2 <7.3 kPa)
- Moderate-to-severe chronic obstructive or restrictive pulmonary disease (FEV1 ≤ 60% predicted, FVC ≤ 60% predicted)
- Women with known pregnancy or breast feeding
- Other clinically significant concomitant disease states (e.g., severe renal or hepatic disease, unstable cardiovascular disease, etc.)
Concurrent medication with:
- Nitric oxide donors (molsidomine, nicrorandil, etc.)
- Soluble guanylate cyclase stimulators (riociguat)
- Potent CYP3A4 inhibitors (azoles, clarithromycin, protease inhibitors)
- History of anterior ischemic optic neuropathy or hereditary retinal disease
- Participation in another study with investigational drug with potential influence the study data within the 30 days preceding and during the present study.
- Known allergies or hypersensitivity to sildenafil 20mg (Revatio 20mg) or dextrose candy (Dextroenergy) including any of its components
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: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: Intervention Order A
Group A will receive the active comparator first (Sildenafil 20mg) in accordance with the Cross-Over trial design.
|
Administration of Dextrose Candy by mouth as a tablet.
Otros nombres:
Administration of Sildenafil 20mg by mouth as a tablet.
Otros nombres:
|
|
Otro: Intervention Order B
Group B will receive the placebo comparator first (Dextrose Candy) in accordance with the Cross-Over trial design.
|
Administration of Dextrose Candy by mouth as a tablet.
Otros nombres:
Administration of Sildenafil 20mg by mouth as a tablet.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Maximum workload (Wmax)
Periodo de tiempo: Within 1 - 90 days
|
The difference in maximum workload (Wmax) attained during maximum spiroergometry 45 minutes after treatment with Sildenafil 20mg (Revatio 20mg) versus dextrose candy (Dextro Energy).
|
Within 1 - 90 days
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time to Exhaustion (Tmax)
Periodo de tiempo: Within 1 - 90 days
|
Difference in Time to Exhaustion (Tmax)attained during CWRET after treatment with Sildenafil 20mg (Revatio 20mg) versus dextrose candy (Dextro Energy)
|
Within 1 - 90 days
|
|
Cardiometabolic parameters (CPET, CWRET): Oxygen Saturation (SpO2)
Periodo de tiempo: Within 1 - 90 days
|
Change in Oxygen Saturation (SpO2) during CPET / CWRET
|
Within 1 - 90 days
|
|
Focused Stress-Echocardiography (Right Heart): Stroke Volume (SV)
Periodo de tiempo: Within 1 - 90 days
|
Change in Stroke Volume (SV) during CPET
|
Within 1 - 90 days
|
|
Arterial blood gases: Arterial Partial Pressure of Oxygen (PaO2)
Periodo de tiempo: Within 1 - 90 days
|
Change in Arterial Partial Pressure of Oxygen (PaO2) during CPET.
|
Within 1 - 90 days
|
|
Borg CR10 (Borg Category-Ratio 10 Scale)
Periodo de tiempo: Within 1 - 90 days
|
Changes in Borg CR10 questionnaire (Borg Category-Ratio 10 Scale) after CPET / CWRET (0-10, higher values indicate more severe symptoms)
|
Within 1 - 90 days
|
|
Focused Stress-Echocardiography (Right Heart): Tricuspid Regurgitation Pressure Gradient (TRPG)
Periodo de tiempo: Within 1 - 90 days
|
Change in Tricuspid Regurgitation Pressure Gradient (TRPG) during CPET
|
Within 1 - 90 days
|
|
Cardiometabolic parameters (CPET / CWRET): Blood Pressure (BP)
Periodo de tiempo: Within 1 - 90 days
|
Change in Blood Pressure (BP) during CPET / CWRET
|
Within 1 - 90 days
|
|
Cardiometabolic parameters (CPET / CWRET): Heart Rate (HR)
Periodo de tiempo: Within 1 - 90 days
|
Change in Heart Rate (HR) during CPET / CWRET
|
Within 1 - 90 days
|
|
Cardiometabolic parameters (CPET / CWRET): Rate Pressure Product (RPP)
Periodo de tiempo: Within 1 - 90 days
|
Change in Rate Pressure Product (RPP) during CPET / CWRET
|
Within 1 - 90 days
|
|
Cardiometabolic parameters (CPET / CWRET): Maximum Uptake of Oxygen (V'O2max)
Periodo de tiempo: Within 1 - 90 days
|
Change Maximum Uptake of Oxygen (V'O2max) during CPET / CWRET
|
Within 1 - 90 days
|
|
Cardiometabolic parameters (CPET / CWRET): Maximum Carbon Dioxide Production (V'CO2max)
Periodo de tiempo: Within 1 - 90 days
|
Change in Maximum Carbon Dioxide Production (V'CO2max) during CPET / CWRET
|
Within 1 - 90 days
|
|
Cardiometabolic parameters (CPET / CWRET): Maximum Minute Ventilation (V'Emax)
Periodo de tiempo: Within 1 - 90 days
|
Change in Maximum Minute Ventilation (V'Emax) during CPET / CWRET
|
Within 1 - 90 days
|
|
Cardiometabolic parameters (CPET / CWRET): Maximum Ventilatory Equivalent for Oxygen (V'E/VO2)
Periodo de tiempo: Within 1 - 90 days
|
Change in Maximum Ventilatory Equivalent for Oxygen (V'E/VO2) during CPET / CWRET
|
Within 1 - 90 days
|
|
Cardiometabolic parameters (CPET / CWRET): Maximum Ventilatory Equivalent for Carbon Dioxide (V'E/VCO2)
Periodo de tiempo: Within 1 - 90 days
|
Change in Maximum Ventilatory Equivalent for Carbon Dioxide (V'E/VCO2) during CPET / CWRET
|
Within 1 - 90 days
|
|
Cardiometabolic parameters (CPET / CWRET): Breathing Frequency (BF)
Periodo de tiempo: Within 1 - 90 days
|
Change in Breathing Frequency (BF) during CPET / CWRET
|
Within 1 - 90 days
|
|
Cardiometabolic parameters (CPET / CWRET): Breathing Reserve (BR)
Periodo de tiempo: Within 1 - 90 days
|
Change in Breathing Reserve (BR) during CPET / CWRET
|
Within 1 - 90 days
|
|
Arterial blood gases: Arterial Partial Pressure of Carbon Dioxide (PaCO2)
Periodo de tiempo: Within 1 - 90 days
|
Change in Arterial Partial Pressure of Carbon Dioxide (PaCO2) during CPET.
|
Within 1 - 90 days
|
|
Arterial blood gases: Bicarbonate (HCO3-)
Periodo de tiempo: Within 1 - 90 days
|
Change in Bicarbonate HCO3- before and after CPET.
|
Within 1 - 90 days
|
|
Arterial blood gases: Arterial Oxygen Saturation (SaO2)
Periodo de tiempo: Within 1 - 90 days
|
Change in Arterial Oxygen Saturation (SaO2) before and after CPET.
|
Within 1 - 90 days
|
|
Arterial blood gases: Base Excess (BE)
Periodo de tiempo: Within 1 - 90 days
|
Change in Base Excess (BE) before and after CPET.
|
Within 1 - 90 days
|
|
Arterial blood gases: Lactate (lac)
Periodo de tiempo: Within 1 - 90 days
|
Change in Lactate (lac) concentration before and after CPET.
|
Within 1 - 90 days
|
|
Arterial blood gases: Hemoglobin (Hb)
Periodo de tiempo: Within 1 - 90 days
|
Change in Hemoglobin (Hb) before and after CPET.
|
Within 1 - 90 days
|
|
Arterial blood gases: Hematocrit (Hct)
Periodo de tiempo: Within 1 - 90 days
|
Change in Hematocrit (Hct) before and after CPET.
|
Within 1 - 90 days
|
|
Focused Stress-Echocardiography (Right Heart): Tricuspid Regurgitation Velocity (TRV)
Periodo de tiempo: Within 1 - 90 days
|
Change in Tricuspid Regurgitation Velocity (TRV) during CPET
|
Within 1 - 90 days
|
|
Focused Stress-Echocardiography (Right Heart): Right Atrial Pressure (RAP)
Periodo de tiempo: Within 1 - 90 days
|
Change in Right Atrial Pressure (RAP) during CPET
|
Within 1 - 90 days
|
|
Focused Stress-Echocardiography (Right Heart): Systolic Pulmonary Arterial Pressure (sPAP)
Periodo de tiempo: Within 1 - 90 days
|
Change in Systolic Pulmonary Arterial Pressure (sPAP) during CPET
|
Within 1 - 90 days
|
|
Focused Stress-Echocardiography (Right Heart): Fractional Area Change (FAC)
Periodo de tiempo: Within 1 - 90 days
|
Change in Fractional Area Change (FAC) during CPET
|
Within 1 - 90 days
|
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Focused Stress-Echocardiography (Right Heart): Tricuspid Annular Plane Systolic Excursion (TAPSE)
Periodo de tiempo: Within 1 - 90 days
|
Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) during CPET
|
Within 1 - 90 days
|
|
Focused Stress-Echocardiography (Right Heart): Ratio of Tricuspid Regurgitation Pressure Gradient to Cardiac Output (TRPG/CO)
Periodo de tiempo: Within 1 - 90 days
|
Change in Ratio of Tricuspid Regurgitation Pressure Gradient to Cardiac Output (TRPG/CO) during CPET
|
Within 1 - 90 days
|
|
Focused Stress-Echocardiography (Right Heart): Cardiac Output (CO)
Periodo de tiempo: Within 1 - 90 days
|
Change in Cardiac Output (CO) during CPET
|
Within 1 - 90 days
|
|
Focused Stress-Echocardiography (Right Heart): Pulmonary Vascular Resistance (PVR)
Periodo de tiempo: Within 1 - 90 days
|
Change in Pulmonary Vascular Resistance (PVR) during CPET
|
Within 1 - 90 days
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Safety Profile / (S)AEs
Periodo de tiempo: (S)AEs will be assessed immediately after each intervention (A or B) during the corresponding study visits (1 and 2).
|
Safety and (S)AEs of each Intervention [sildenafil 20mg (Revatio 20mg) and dextrose candy (Dextro Energy)] will be assessed.
|
(S)AEs will be assessed immediately after each intervention (A or B) during the corresponding study visits (1 and 2).
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Silvia Ulrich, Prof. Dr. med., University of Zurich
- Investigador principal: Arcangelo F Carta, Dr. med., University of Zurich
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 (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
1 de abril de 2028
Finalización del estudio (Estimado)
1 de diciembre de 2028
Fechas de registro del estudio
Enviado por primera vez
17 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
12 de septiembre de 2026
Publicado por primera vez (Actual)
17 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
12 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Hipertensión Pulmonar
- Hipertensión arterial pulmonar
- Compuestos de azufre
- Químicos orgánicos
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Compuestos heterocíclicos, 2 anillos
- Compuestos heterocíclicos, anillo fusionado
- Carbohidratos
- Amidas
- Purinas
- Azúcar
- Sulfonamidas
- Sulfonas
- Piperazines
- Hexisos
- Monosacáridos
- Citrato de sildenafilo
- Glucosa
Otros números de identificación del estudio
- KEK-ZH-Nr. 2025-02557
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Access to anonymised IPD that underlie results in a publication will be considered individually upon reasonable request.
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. .