Effect of Short-term Oxygen During CPET in HFpEF

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Short-term Ambulatory Oxygen Therapy on Cardiopulmonary Exercise Capacity (CPET) in Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)

Conditions
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Heart Failure, Diastolic (HFpEF)

Intervention / Treatment
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* Procedure: Oxygen application
* Procedure: Sham room air


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supplemental oxygen<br>Supplemental oxygen will be applied via a mask during CPET | Procedure: Oxygen application<br>* Oxygen application Supplemental oxygen via mask<br>|
| Sham Comparator: Sham room air<br>Room air will be applied similarly to oxygen | Procedure: Sham room air<br>* Room air will be applied via mask<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Work Rate (Watt) | Maximal Work Rate (Watt max) measured during cardiopulmonary exercise test oxygen vs. room air | 1 day | 
| Endurance Time (s) | Endurance (s) with 75% Wmax measured during cardiopulmonary exercise test oxygen vs. room air | 1 day | 

Secondary Outcome Measures

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