HEXASN: Hemodynamic Effects During Exercise in Patients With Pulmonary Hypertension Receiving Sildenafil

Sponsor

University of Zurich (Other)

Overall Status

Recruiting

CT.gov ID

NCT04706546

Collaborator

(none)

Enrollment

Locations

Arms

46.9

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To study hemodynamic effects of Sildenafil during exercise in patients with pulmonary hypertension.

Condition or Disease	Intervention/Treatment	Phase
Hypertension, Pulmonary	Other: Hemodynamic effect of exercise under Sildenafil Other: Hemodynamic effect of exercise	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

Hemodynamic Effects of Acute Normobaric Hypoxia During Exercise in Patients With Pulmonary Hypertension: Single-center Randomized Controlled Trial

Actual Study Start Date :

Feb 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hemodynamic effect of exercise under Sildenafil Inhalation of room air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise under SIldenafil.	Other: Hemodynamic effect of exercise under Sildenafil Inhalation of room air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise under SIldenafil.
Other: Hemodynamic effect of exercise Inhalation of room air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise.	Other: Hemodynamic effect of exercise Inhalation of room air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise.

Arm

Intervention/Treatment

Experimental: Hemodynamic effect of exercise under Sildenafil

Inhalation of room air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise under SIldenafil.

Other: Hemodynamic effect of exercise under Sildenafil

Inhalation of room air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise under SIldenafil.

Other: Hemodynamic effect of exercise

Inhalation of room air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise.

Other: Hemodynamic effect of exercise

Inhalation of room air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise.

Outcome Measures

Primary Outcome Measures

mean pulmonary artery pressure (mPAP) / cardiac output (CO) [4 hours]
Difference in mPAP/CO during exercise between tests under normoxia with/without Sildenafil

Secondary Outcome Measures

Differences in pulmonary arterial pressure [4 hours]
Differences in pulmonary arterial pressure at rest and during exercise under normoxia with/without Sildenafil
Differences in cardiac output [4 hours]
Differences in cardiac output at rest and during exercise under normoxia with/without Sildenafil
Differences in pulmonary vascular resistance [4 hours]
Differences in pulmonary vascular resistance at rest and during exercise under normoxia with/without Sildenafil
Differences in pulmonary artery wedge pressure [4 hours]
Differences in pulmonary artery wedge pressure at rest and during exercise under normoxia with/without Sildenafil
Differences in right atrial pressure [4 hours]
Differences in right atrial pressure at rest and during exercise under normoxia with/without Sildenafil
Differences in mixed venous oxygen saturation [4 hours]
Differences in mixed venous oxygen saturation at rest and during exercise under normoxia with/without Sildenafil
Differences in heart rate [4 hours]
Differences in heart rate at rest and during exercise, under normoxia with/without Sildenafil
Differences in blood pressure (systolic and diastolic) [4 hours]
Differences in blood pressure (systolic and diastolic) at rest and during exercise, under normoxia with/without Sildenafil
Differences in oxygen saturation [4 hours]
Differences in oxygen saturation at rest and during exercise, under normoxia with/without Sildenafil
Differences in arterial blood gases [4 hours]
Differences in arterial blood gases at rest and during exercise under normoxia with/without Sildenafil
Differences in mixed venous blood gases [4 hours]
Differences in mixed venous blood gases at rest and during exercise under normoxia with/without Sildenafil
Differences in cerebral tissue oxygenation [4 hours]
Differences in cerebral tissue oxygenation at rest and during exercise, under normoxia with/without Sildenafil
Differences in muscle tissue oxygenation [4 hours]
Differences in muscle tissue oxygenation at rest and during exercise, under normoxia with/without Sildenafil
Differences in symptoms (Borg dyspnoea) [4 hours]
Differences in symptoms (Borg dyspnoea, Borg CR10, scale 0-10) at rest and during exercise under normoxia with/without Sildenafil
Differences in symptoms (leg effort) [4 hours]
Differences in symptoms (leg effort, scale 0-10, 10 is maximal exhaustion) at rest and during exercise under normoxia with/without Sildenafil

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Informed consent as documented by signature (Appendix Informed Consent Form)
PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure >20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization

Exclusion Criteria:

resting partial pressure of oxygen <8 kilopascal at Zürich altitude on ambient air
exposure to an altitude >1000 m for ≥3 nights during the last 2 weeks before the study
inability to follow the procedures of the study
patients who take nitrates
other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)