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

ConditionPulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSilvia Ulrich

About this 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Dextrose

    Drug

    Administration of Dextrose Candy by mouth as a tablet.

  • Sildenafil 20mg

    Drug

    Administration of Sildenafil 20mg by mouth as a tablet.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Intervention Order AOther 2 interventions
Group B: Intervention Order BOther 2 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
Within 1 - 90 days

Secondary outcomes

1

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)

Time frame
Within 1 - 90 days
2

Cardiometabolic parameters (CPET, CWRET): Oxygen Saturation (SpO2)

Change in Oxygen Saturation (SpO2) during CPET / CWRET

Time frame
Within 1 - 90 days
3

Focused Stress-Echocardiography (Right Heart): Stroke Volume (SV)

Change in Stroke Volume (SV) during CPET

Time frame
Within 1 - 90 days
4

Arterial blood gases: Arterial Partial Pressure of Oxygen (PaO2)

Change in Arterial Partial Pressure of Oxygen (PaO2) during CPET.

Time frame
Within 1 - 90 days

Other outcomes

1

Safety Profile / (S)AEs

Safety and (S)AEs of each Intervention \[sildenafil 20mg (Revatio 20mg) and dextrose candy (Dextro Energy)\] will be assessed.

Time frame
(S)AEs will be assessed immediately after each intervention (A or B) during the corresponding study visits (1 and 2).

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Silvia Ulrich

Lead sponsor

University of Zurich

Sponsor institution

Source ClinicalTrials.gov
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