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The Effect of Additive On-Demand Sildenafil vs. Dextrose Candy on Maximum Exercise Capacity in Pulmonary Arterial Hypertension (Pocket-PH)

12. september 2026 oppdatert av: 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).

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

20

Fase

  • Fase 2
  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Sveits
    • Canton of Zurich
      • Zurich, Canton of Zurich, Sveits, 8091
        • Rekruttering
        • University Hospital of Zurich, Department of Pulmonology
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Intervention Order A
Group A will receive the active comparator first (Sildenafil 20mg) in accordance with the Cross-Over trial design.
Legemiddel: Dextrose
Administration of Dextrose Candy by mouth as a tablet.
Andre navn:
  • Dextro Energy
  • Dextrose Candy
Legemiddel: Sildenafil 20mg
Administration of Sildenafil 20mg by mouth as a tablet.
Andre navn:
  • Revatio 20mg
Annen: Intervention Order B
Group B will receive the placebo comparator first (Dextrose Candy) in accordance with the Cross-Over trial design.
Legemiddel: Dextrose
Administration of Dextrose Candy by mouth as a tablet.
Andre navn:
  • Dextro Energy
  • Dextrose Candy
Legemiddel: Sildenafil 20mg
Administration of Sildenafil 20mg by mouth as a tablet.
Andre navn:
  • Revatio 20mg

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Maximum workload (Wmax)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to Exhaustion (Tmax)
Tidsramme: 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)
Tidsramme: Within 1 - 90 days
Change in Oxygen Saturation (SpO2) during CPET / CWRET
Within 1 - 90 days
Focused Stress-Echocardiography (Right Heart): Stroke Volume (SV)
Tidsramme: Within 1 - 90 days
Change in Stroke Volume (SV) during CPET
Within 1 - 90 days
Arterial blood gases: Arterial Partial Pressure of Oxygen (PaO2)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Within 1 - 90 days
Change in Tricuspid Regurgitation Pressure Gradient (TRPG) during CPET
Within 1 - 90 days
Cardiometabolic parameters (CPET / CWRET): Blood Pressure (BP)
Tidsramme: Within 1 - 90 days
Change in Blood Pressure (BP) during CPET / CWRET
Within 1 - 90 days
Cardiometabolic parameters (CPET / CWRET): Heart Rate (HR)
Tidsramme: Within 1 - 90 days
Change in Heart Rate (HR) during CPET / CWRET
Within 1 - 90 days
Cardiometabolic parameters (CPET / CWRET): Rate Pressure Product (RPP)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Within 1 - 90 days
Change in Breathing Frequency (BF) during CPET / CWRET
Within 1 - 90 days
Cardiometabolic parameters (CPET / CWRET): Breathing Reserve (BR)
Tidsramme: 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)
Tidsramme: Within 1 - 90 days
Change in Arterial Partial Pressure of Carbon Dioxide (PaCO2) during CPET.
Within 1 - 90 days
Arterial blood gases: Bicarbonate (HCO3-)
Tidsramme: Within 1 - 90 days
Change in Bicarbonate HCO3- before and after CPET.
Within 1 - 90 days
Arterial blood gases: Arterial Oxygen Saturation (SaO2)
Tidsramme: Within 1 - 90 days
Change in Arterial Oxygen Saturation (SaO2) before and after CPET.
Within 1 - 90 days
Arterial blood gases: Base Excess (BE)
Tidsramme: Within 1 - 90 days
Change in Base Excess (BE) before and after CPET.
Within 1 - 90 days
Arterial blood gases: Lactate (lac)
Tidsramme: Within 1 - 90 days
Change in Lactate (lac) concentration before and after CPET.
Within 1 - 90 days
Arterial blood gases: Hemoglobin (Hb)
Tidsramme: Within 1 - 90 days
Change in Hemoglobin (Hb) before and after CPET.
Within 1 - 90 days
Arterial blood gases: Hematocrit (Hct)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Within 1 - 90 days
Change in Fractional Area Change (FAC) during CPET
Within 1 - 90 days
Focused Stress-Echocardiography (Right Heart): Tricuspid Annular Plane Systolic Excursion (TAPSE)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Within 1 - 90 days
Change in Cardiac Output (CO) during CPET
Within 1 - 90 days
Focused Stress-Echocardiography (Right Heart): Pulmonary Vascular Resistance (PVR)
Tidsramme: Within 1 - 90 days
Change in Pulmonary Vascular Resistance (PVR) during CPET
Within 1 - 90 days

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Safety Profile / (S)AEs
Tidsramme: (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).

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Silvia Ulrich

Etterforskere

  • Hovedetterforsker: Silvia Ulrich, Prof. Dr. med., University of Zurich
  • Hovedetterforsker: Arcangelo F Carta, Dr. med., University of Zurich

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. april 2028

Studiet fullført (Antatt)

1. desember 2028

Datoer for studieregistrering

Først innsendt

17. august 2026

Først innsendt som oppfylte QC-kriteriene

12. september 2026

Først lagt ut (Faktiske)

17. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • KEK-ZH-Nr. 2025-02557

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Access to anonymised IPD that underlie results in a publication will be considered individually upon reasonable request.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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