Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)Phase 2/3Pocket-PHNCT07824674
The Effect of Additive On-Demand Sildenafil vs. Dextrose Candy on Maximum Exercise Capacity in Pulmonary Arterial Hypertension
A Phase 2/3 study testing Dextrose and Sildenafil 20mg in people with Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH), run by Silvia Ulrich at 1 site in Switzerland.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)
- What is being tested?
- Dextrose and Sildenafil 20mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 26 Oct 2026to Dec 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital of Zurich, Department of Pulmonology
Zurich, Canton of Zurich, 8091
Arcangelo F Carta, Dr. med., +41 44 255 22 20, arcangelo.carta@usz.ch
About this study
Official title: 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).
Read the detailed description
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.
- Being tested
- Dextrose, Sildenafil 20mg
- Keywords
- Sildenafil, Pulmonary Arterial Hypertension, Cardiopulmonary Testing, RCT, CPET, CWRET, Pill-In-The-Pocket
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DextroseDrug
Also called Dextro Energy, Dextrose Candy
Administration of Dextrose Candy by mouth as a tablet.
Sildenafil 20mgDrug
Also called Revatio 20mg
Administration of Sildenafil 20mg by mouth as a tablet.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Order A | Other | Group A will receive the active comparator first (Sildenafil 20mg) in accordance with the Cross-Over trial design. Receives: Drug: Dextrose; Drug: Sildenafil 20mg |
| Intervention Order B | Other | Group B will receive the placebo comparator first (Dextrose Candy) in accordance with the Cross-Over trial design. Receives: Drug: Dextrose; Drug: Sildenafil 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum workload (Wmax)
The difference in maximum workload (Wmax) attained during maximum spiroergometry 45 minutes after treatment with Sildenafil 20mg (Revatio 20mg) versus dextrose candy (Dextro Energy).
Measured: Within 1 - 90 days
Secondary outcomes (31)
Time to Exhaustion (Tmax)
Difference in Time to Exhaustion (Tmax)attained during CWRET after treatment with Sildenafil 20mg (Revatio 20mg) versus dextrose candy (Dextro Energy)
Measured: Within 1 - 90 days
Cardiometabolic parameters (CPET, CWRET): Oxygen Saturation (SpO2)
Change in Oxygen Saturation (SpO2) during CPET / CWRET
Measured: Within 1 - 90 days
Focused Stress-Echocardiography (Right Heart): Stroke Volume (SV)
Change in Stroke Volume (SV) during CPET
Measured: Within 1 - 90 days
Arterial blood gases: Arterial Partial Pressure of Oxygen (PaO2)
Change in Arterial Partial Pressure of Oxygen (PaO2) during CPET.
Measured: Within 1 - 90 days
Borg CR10 (Borg Category-Ratio 10 Scale)
Changes in Borg CR10 questionnaire (Borg Category-Ratio 10 Scale) after CPET / CWRET (0-10, higher values indicate more severe symptoms)
Measured: Within 1 - 90 days
Focused Stress-Echocardiography (Right Heart): Tricuspid Regurgitation Pressure Gradient (TRPG)
Change in Tricuspid Regurgitation Pressure Gradient (TRPG) during CPET
Measured: Within 1 - 90 days
Cardiometabolic parameters (CPET / CWRET): Blood Pressure (BP)
Change in Blood Pressure (BP) during CPET / CWRET
Measured: Within 1 - 90 days
Cardiometabolic parameters (CPET / CWRET): Heart Rate (HR)
Change in Heart Rate (HR) during CPET / CWRET
Measured: Within 1 - 90 days
Cardiometabolic parameters (CPET / CWRET): Rate Pressure Product (RPP)
Change in Rate Pressure Product (RPP) during CPET / CWRET
Measured: Within 1 - 90 days
Cardiometabolic parameters (CPET / CWRET): Maximum Uptake of Oxygen (V'O2max)
Change Maximum Uptake of Oxygen (V'O2max) during CPET / CWRET
Measured: Within 1 - 90 days
Cardiometabolic parameters (CPET / CWRET): Maximum Carbon Dioxide Production (V'CO2max)
Change in Maximum Carbon Dioxide Production (V'CO2max) during CPET / CWRET
Measured: Within 1 - 90 days
Cardiometabolic parameters (CPET / CWRET): Maximum Minute Ventilation (V'Emax)
Change in Maximum Minute Ventilation (V'Emax) during CPET / CWRET
Measured: Within 1 - 90 days
Cardiometabolic parameters (CPET / CWRET): Maximum Ventilatory Equivalent for Oxygen (V'E/VO2)
Change in Maximum Ventilatory Equivalent for Oxygen (V'E/VO2) during CPET / CWRET
Measured: Within 1 - 90 days
Cardiometabolic parameters (CPET / CWRET): Maximum Ventilatory Equivalent for Carbon Dioxide (V'E/VCO2)
Change in Maximum Ventilatory Equivalent for Carbon Dioxide (V'E/VCO2) during CPET / CWRET
Measured: Within 1 - 90 days
Cardiometabolic parameters (CPET / CWRET): Breathing Frequency (BF)
Change in Breathing Frequency (BF) during CPET / CWRET
Measured: Within 1 - 90 days
Cardiometabolic parameters (CPET / CWRET): Breathing Reserve (BR)
Change in Breathing Reserve (BR) during CPET / CWRET
Measured: Within 1 - 90 days
Arterial blood gases: Arterial Partial Pressure of Carbon Dioxide (PaCO2)
Change in Arterial Partial Pressure of Carbon Dioxide (PaCO2) during CPET.
Measured: Within 1 - 90 days
Arterial blood gases: Bicarbonate (HCO3-)
Change in Bicarbonate HCO3- before and after CPET.
Measured: Within 1 - 90 days
Arterial blood gases: Arterial Oxygen Saturation (SaO2)
Change in Arterial Oxygen Saturation (SaO2) before and after CPET.
Measured: Within 1 - 90 days
Arterial blood gases: Base Excess (BE)
Change in Base Excess (BE) before and after CPET.
Measured: Within 1 - 90 days
Arterial blood gases: Lactate (lac)
Change in Lactate (lac) concentration before and after CPET.
Measured: Within 1 - 90 days
Arterial blood gases: Hemoglobin (Hb)
Change in Hemoglobin (Hb) before and after CPET.
Measured: Within 1 - 90 days
Arterial blood gases: Hematocrit (Hct)
Change in Hematocrit (Hct) before and after CPET.
Measured: Within 1 - 90 days
Focused Stress-Echocardiography (Right Heart): Tricuspid Regurgitation Velocity (TRV)
Change in Tricuspid Regurgitation Velocity (TRV) during CPET
Measured: Within 1 - 90 days
Focused Stress-Echocardiography (Right Heart): Right Atrial Pressure (RAP)
Change in Right Atrial Pressure (RAP) during CPET
Measured: Within 1 - 90 days
Focused Stress-Echocardiography (Right Heart): Systolic Pulmonary Arterial Pressure (sPAP)
Change in Systolic Pulmonary Arterial Pressure (sPAP) during CPET
Measured: Within 1 - 90 days
Focused Stress-Echocardiography (Right Heart): Fractional Area Change (FAC)
Change in Fractional Area Change (FAC) during CPET
Measured: Within 1 - 90 days
Focused Stress-Echocardiography (Right Heart): Tricuspid Annular Plane Systolic Excursion (TAPSE)
Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) during CPET
Measured: Within 1 - 90 days
Focused Stress-Echocardiography (Right Heart): Ratio of Tricuspid Regurgitation Pressure Gradient to Cardiac Output (TRPG/CO)
Change in Ratio of Tricuspid Regurgitation Pressure Gradient to Cardiac Output (TRPG/CO) during CPET
Measured: Within 1 - 90 days
Focused Stress-Echocardiography (Right Heart): Cardiac Output (CO)
Change in Cardiac Output (CO) during CPET
Measured: Within 1 - 90 days
Focused Stress-Echocardiography (Right Heart): Pulmonary Vascular Resistance (PVR)
Change in Pulmonary Vascular Resistance (PVR) during CPET
Measured: Within 1 - 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start26 Oct 2026
- Primary completionApr 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, Cross-Over Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Silvia Ulrich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Silvia Ulrich, University of Zurich
- Investigators
- Silvia Ulrich, Prof. Dr. med., Principal investigator, University of ZurichArcangelo F Carta, Dr. med., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824674
- Sponsor's protocol ID
- KEK-ZH-Nr. 2025-02557
- Acronym
- Pocket-PH
- Status last verified
- Sep 2026
- First submitted
- 17 Aug 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to anonymised IPD that underlie results in a publication will be considered individually upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Additive On-Demand Sildenafil vs. Dextrose Candy on Maximum Exercise Capacity in Pulmonary Arterial Hypertension: A Randomized, Cross-Over Trial.
- ClinicalTrials.gov ID
- NCT07824674
- Acronym / sponsor ID
- Pocket-PH / KEK-ZH-Nr. 2025-02557
- Keywords
- Sildenafil, Pulmonary Arterial Hypertension, Cardiopulmonary Testing, RCT, CPET, CWRET, Pill-In-The-Pocket
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Silvia UlrichUniversity, hospital or other
- Study start
- 26 Oct 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Cross-Over Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Order A | Other | Drug: Dextrose, Drug: Sildenafil 20mgGroup A will receive the active comparator first (Sildenafil 20mg) in accordance with the Cross-Over trial design. |
| Intervention Order B | Other | Drug: Dextrose, Drug: Sildenafil 20mgGroup B will receive the placebo comparator first (Dextrose Candy) in accordance with the Cross-Over trial design. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DextroseAlso: Dextro Energy, Dextrose CandyAdministration of Dextrose Candy by mouth as a tablet. | Drug | Intervention Order A, Intervention Order B |
| Sildenafil 20mgAlso: Revatio 20mgAdministration of Sildenafil 20mg by mouth as a tablet. | Drug | Intervention Order A, Intervention Order B |
Primary outcome
Maximum workload (Wmax)
Time frame: 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).
31 secondary outcomes
Time to Exhaustion (Tmax)
Time frame: Within 1 - 90 days
Cardiometabolic parameters (CPET, CWRET): Oxygen Saturation (SpO2)
Time frame: Within 1 - 90 days
Focused Stress-Echocardiography (Right Heart): Stroke Volume (SV)
Time frame: Within 1 - 90 days
Arterial blood gases: Arterial Partial Pressure of Oxygen (PaO2)
Time frame: Within 1 - 90 days
Borg CR10 (Borg Category-Ratio 10 Scale)
Time frame: Within 1 - 90 days
Focused Stress-Echocardiography (Right Heart): Tricuspid Regurgitation Pressure Gradient (TRPG)
Time frame: Within 1 - 90 days
Cardiometabolic parameters (CPET / CWRET): Blood Pressure (BP)
Time frame: Within 1 - 90 days
Cardiometabolic parameters (CPET / CWRET): Heart Rate (HR)
Time frame: Within 1 - 90 days
Cardiometabolic parameters (CPET / CWRET): Rate Pressure Product (RPP)
Time frame: Within 1 - 90 days
Cardiometabolic parameters (CPET / CWRET): Maximum Uptake of Oxygen (V'O2max)
Time frame: Within 1 - 90 days
Cardiometabolic parameters (CPET / CWRET): Maximum Carbon Dioxide Production (V'CO2max)
Time frame: Within 1 - 90 days
Cardiometabolic parameters (CPET / CWRET): Maximum Minute Ventilation (V'Emax)
Time frame: Within 1 - 90 days
Cardiometabolic parameters (CPET / CWRET): Maximum Ventilatory Equivalent for Oxygen (V'E/VO2)
Time frame: Within 1 - 90 days
Cardiometabolic parameters (CPET / CWRET): Maximum Ventilatory Equivalent for Carbon Dioxide (V'E/VCO2)
Time frame: Within 1 - 90 days
Cardiometabolic parameters (CPET / CWRET): Breathing Frequency (BF)
Time frame: Within 1 - 90 days
Cardiometabolic parameters (CPET / CWRET): Breathing Reserve (BR)
Time frame: Within 1 - 90 days
Arterial blood gases: Arterial Partial Pressure of Carbon Dioxide (PaCO2)
Time frame: Within 1 - 90 days
Arterial blood gases: Bicarbonate (HCO3-)
Time frame: Within 1 - 90 days
Arterial blood gases: Arterial Oxygen Saturation (SaO2)
Time frame: Within 1 - 90 days
Arterial blood gases: Base Excess (BE)
Time frame: Within 1 - 90 days
Arterial blood gases: Lactate (lac)
Time frame: Within 1 - 90 days
Arterial blood gases: Hemoglobin (Hb)
Time frame: Within 1 - 90 days
Arterial blood gases: Hematocrit (Hct)
Time frame: Within 1 - 90 days
Focused Stress-Echocardiography (Right Heart): Tricuspid Regurgitation Velocity (TRV)
Time frame: Within 1 - 90 days
Focused Stress-Echocardiography (Right Heart): Right Atrial Pressure (RAP)
Time frame: Within 1 - 90 days
Focused Stress-Echocardiography (Right Heart): Systolic Pulmonary Arterial Pressure (sPAP)
Time frame: Within 1 - 90 days
Focused Stress-Echocardiography (Right Heart): Fractional Area Change (FAC)
Time frame: Within 1 - 90 days
Focused Stress-Echocardiography (Right Heart): Tricuspid Annular Plane Systolic Excursion (TAPSE)
Time frame: Within 1 - 90 days
Focused Stress-Echocardiography (Right Heart): Ratio of Tricuspid Regurgitation Pressure Gradient to Cardiac Output (TRPG/CO)
Time frame: Within 1 - 90 days
Focused Stress-Echocardiography (Right Heart): Cardiac Output (CO)
Time frame: Within 1 - 90 days
Focused Stress-Echocardiography (Right Heart): Pulmonary Vascular Resistance (PVR)
Time frame: Within 1 - 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No. Access to anonymised IPD that underlie results in a publication will be considered individually upon reasonable request.
Related trials for Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)
RecruitingObservational study
Nailfold Capillaroscopy in PH
Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH), Pulmonary Hypertension (World Health Organization Group 3)
RecruitingObservational study
The Impact of ERA Switching on Risk Stratification in Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension, Pulmonary Arterial Hypertension (PAH)
Not yet recruitingPhase 3
A Phase 3 Study of Extended-release Tacrolimus in Subjects With Pulmonary Arterial Hypertension and Functional Limitations
Pulmonary Arterial Hypertension, Pulmonary Arterial Hypertension (PAH)
RecruitingPhase 2
A Trial of "APL-9796'' in Adults With Pulmonary Hypertension
Pulmonary Arterial Hypertension
Recruiting
Validation of a Patient Knowledge Questionnaire for Pulmonary Hypertension
Pulmonary Arterial Hypertension (PAH), Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Silvia Ulrich, Prof. Dr. med. principal investigator
University of Zurich
Arcangelo F Carta, Dr. med. principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dextrose and Sildenafil 20mg in people with Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH), run by Silvia Ulrich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arcangelo F Carta, MD (+41 44 255 22 20, arcangelo.carta@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum workload (Wmax) (time frame: Within 1 - 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.