Hemodynamic Effects During Exercise in Patients With Pulmonary Hypertension Receiving Sildenafil

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

Sponsors

Lead Sponsor: University of Zurich

Source University of Zurich
Brief Summary

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

Overall Status Not yet recruiting
Start Date February 1, 2021
Completion Date December 31, 2024
Primary Completion Date December 31, 2023
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
mean pulmonary artery pressure (mPAP) / cardiac output (CO) 4 hours
Secondary Outcome
Measure Time Frame
Differences in pulmonary arterial pressure 4 hours
Differences in cardiac output 4 hours
Differences in pulmonary vascular resistance 4 hours
Differences in pulmonary artery wedge pressure 4 hours
Differences in right atrial pressure 4 hours
Differences in mixed venous oxygen saturation 4 hours
Differences in heart rate 4 hours
Differences in blood pressure (systolic and diastolic) 4 hours
Differences in oxygen saturation 4 hours
Differences in arterial blood gases 4 hours
Differences in mixed venous blood gases 4 hours
Differences in cerebral tissue oxygenation 4 hours
Differences in muscle tissue oxygenation 4 hours
Differences in symptoms (Borg dyspnoea) 4 hours
Differences in symptoms (leg effort) 4 hours
Enrollment 24
Condition
Intervention

Intervention Type: Other

Intervention Name: Hemodynamic effect of exercise under Sildenafil

Description: 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.

Arm Group Label: Hemodynamic effect of exercise under Sildenafil

Intervention Type: Other

Intervention Name: Hemodynamic effect of exercise

Description: 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 Group Label: Hemodynamic effect of exercise

Eligibility

Criteria:

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)

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Silvia Ulrich, Prof. Dr. Principal Investigator UniversityHospital Zurich, Department of Pulmonology
Overall Contact

Last Name: Silvia Ulrich, Prof. Dr.

Phone: +41442552220

Email: [email protected]

Location
Facility: UniversityHospital Zurich, Department of Pulmonology
Location Countries

Switzerland

Verification Date

January 2021

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Hemodynamic effect of exercise under Sildenafil

Type: Experimental

Description: 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.

Label: Hemodynamic effect of exercise

Type: Other

Description: 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.

Acronym HEXASN
Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Other

Masking: Single (Participant)

Source: ClinicalTrials.gov