Effect of Short-term Oxygen During CPET in HFpEF

Not Applicable

Completed

• Conditions: Heart Failure, Diastolic (HFpEF)
• Interventions: Procedure: Sham room air; Procedure: Oxygen application

• Registration Number: NCT04157660
• Lead Sponsor: University of Zurich

Brief Summary

In a randomized, sham-controlled crossover trial the investigators will test whether supplemental oxygen given during cardiopulmonary exercise testing will improve exercise performance and physiological parameters in patients with heart failure with preserved ejection fraction.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-30
• Study Start: 2019-09-12
• Study First Submitted QC: 2019-11-07
• Study First Posted: 2019-11-08
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-11
• Last Update Posted: 2021-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• HFpEF, stable medication for at least 4 weeks.

Exclusion Criteria

• instable status, pregnancy, clinically relevant concomitant diseases, inability to follow the study procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham room air	Sham room air	Room air will be applied similarly to oxygen
Supplemental oxygen	Oxygen application	Supplemental oxygen will be applied via a mask during CPET

Primary Outcome Measures

Name	Time	Method
Work Rate (Watt)	1 day	Maximal Work Rate (Watt max) measured during cardiopulmonary exercise test oxygen vs. room air
Endurance Time (s)	1 day	Endurance (s) with 75% Wmax measured during cardiopulmonary exercise test oxygen vs. room air

Secondary Outcome Measures

Name	Time	Method
Respiratory Exchange Ratio (RER)	1 day	measured during cardiopulmonary exercise test oxygen vs. room air
Changes in arterial blood parameters (pH)	1 day	measured during cardiopulmonary exercise test oxygen vs. room air
Changes in arterial blood parameters (PaO2)	1 day	measured during cardiopulmonary exercise test oxygen vs. room air
Changes in arterial blood parameters (PaCO2)	1 day	measured during cardiopulmonary exercise test oxygen vs. room air
Peak Oxygen uptake (VO2 max)	1 day	measured during cardiopulmonary exercise test oxygen vs. room air
Changes in arterial blood parameters (Lactat)	1 day	measured during cardiopulmonary exercise test oxygen vs. room air
muscle tissue oxygen	1 day	Oxygen Saturation in the muscle measured with near-infrared spectroscopy oxygen vs. room air
cerebral tissue oxygen	1 day	Oxygen Saturation in the brain measured with near-infrared spectroscopy oxygen vs. room air
Changes in arterial blood parameters (Bicarbonate)	1 day	measured during cardiopulmonary exercise test oxygen vs. room air

Trial Locations

Locations (1)

University Hospital Zurich, Division of Pneumology; 🇨🇭 Zürich, Switzerland