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

2026년 9월 12일 업데이트: 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).

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

20

단계

  • 2 단계
  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 스위스
    • Canton of Zurich
      • Zurich, Canton of Zurich, 스위스, 8091
        • 모병
        • University Hospital of Zurich, Department of Pulmonology
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
다른: Intervention Order A
Group A will receive the active comparator first (Sildenafil 20mg) in accordance with the Cross-Over trial design.
의약품: Dextrose
Administration of Dextrose Candy by mouth as a tablet.
다른 이름들:
  • Dextro Energy
  • Dextrose Candy
의약품: Sildenafil 20mg
Administration of Sildenafil 20mg by mouth as a tablet.
다른 이름들:
  • Revatio 20mg
다른: Intervention Order B
Group B will receive the placebo comparator first (Dextrose Candy) in accordance with the Cross-Over trial design.
의약품: Dextrose
Administration of Dextrose Candy by mouth as a tablet.
다른 이름들:
  • Dextro Energy
  • Dextrose Candy
의약품: Sildenafil 20mg
Administration of Sildenafil 20mg by mouth as a tablet.
다른 이름들:
  • Revatio 20mg

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Maximum workload (Wmax)
기간: 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

2차 결과 측정

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

기타 결과 측정

결과 측정
측정값 설명
기간
Safety Profile / (S)AEs
기간: (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).

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Silvia Ulrich

수사관

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2028년 4월 1일

연구 완료 (추정된)

2028년 12월 1일

연구 등록 날짜

최초 제출

2026년 8월 17일

QC 기준을 충족하는 최초 제출

2026년 9월 12일

처음 게시됨 (실제)

2026년 9월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 12일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • KEK-ZH-Nr. 2025-02557

개별 참가자 데이터(IPD) 계획

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아니요

IPD 계획 설명

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다