Back to resultsEffect of Short-term Oxygen During CPET in HFpEF
Primary Purpose
Heart Failure, Diastolic (HFpEF)
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Oxygen application
Sham room air
Sponsored by
About this trial
This is an interventional supportive care trial for Heart Failure, Diastolic (HFpEF)
Eligibility Criteria
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
Sites / Locations
- University Hospital Zurich, Division of Pneumology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Supplemental oxygen
Sham room air
Arm Description
Supplemental oxygen will be applied via a mask during CPET
Room air will be applied similarly to oxygen
Outcomes
Primary Outcome Measures
Work Rate (Watt)
Maximal Work Rate (Watt max) measured during cardiopulmonary exercise test oxygen vs. room air
Endurance Time (s)
Endurance (s) with 75% Wmax measured during cardiopulmonary exercise test oxygen vs. room air
Secondary Outcome Measures
Peak Oxygen uptake (VO2 max)
measured during cardiopulmonary exercise test oxygen vs. room air
Respiratory Exchange Ratio (RER)
measured during cardiopulmonary exercise test oxygen vs. room air
Changes in arterial blood parameters (pH)
measured during cardiopulmonary exercise test oxygen vs. room air
Changes in arterial blood parameters (PaO2)
measured during cardiopulmonary exercise test oxygen vs. room air
Changes in arterial blood parameters (PaCO2)
measured during cardiopulmonary exercise test oxygen vs. room air
Changes in arterial blood parameters (Lactat)
measured during cardiopulmonary exercise test oxygen vs. room air
Changes in arterial blood parameters (Bicarbonate)
measured during cardiopulmonary exercise test oxygen vs. room air
muscle tissue oxygen
Oxygen Saturation in the muscle measured with near-infrared spectroscopy oxygen vs. room air
cerebral tissue oxygen
Oxygen Saturation in the brain measured with near-infrared spectroscopy oxygen vs. room air
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04157660
Brief Title
Effect of Short-term Oxygen During CPET in HFpEF
Official Title
Effect of Short-term Ambulatory Oxygen Therapy on Cardiopulmonary Exercise Capacity (CPET) in Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 12, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Diastolic (HFpEF)
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supplemental oxygen
Arm Type
Experimental
Arm Description
Supplemental oxygen will be applied via a mask during CPET
Arm Title
Sham room air
Arm Type
Sham Comparator
Arm Description
Room air will be applied similarly to oxygen
Intervention Type
Procedure
Intervention Name(s)
Oxygen application
Intervention Description
Oxygen application Supplemental oxygen via mask
Intervention Type
Procedure
Intervention Name(s)
Sham room air
Intervention Description
Room air will be applied via mask
Primary Outcome Measure Information:
Title
Work Rate (Watt)
Description
Maximal Work Rate (Watt max) measured during cardiopulmonary exercise test oxygen vs. room air
Time Frame
1 day
Title
Endurance Time (s)
Description
Endurance (s) with 75% Wmax measured during cardiopulmonary exercise test oxygen vs. room air
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Peak Oxygen uptake (VO2 max)
Description
measured during cardiopulmonary exercise test oxygen vs. room air
Time Frame
1 day
Title
Respiratory Exchange Ratio (RER)
Description
measured during cardiopulmonary exercise test oxygen vs. room air
Time Frame
1 day
Title
Changes in arterial blood parameters (pH)
Description
measured during cardiopulmonary exercise test oxygen vs. room air
Time Frame
1 day
Title
Changes in arterial blood parameters (PaO2)
Description
measured during cardiopulmonary exercise test oxygen vs. room air
Time Frame
1 day
Title
Changes in arterial blood parameters (PaCO2)
Description
measured during cardiopulmonary exercise test oxygen vs. room air
Time Frame
1 day
Title
Changes in arterial blood parameters (Lactat)
Description
measured during cardiopulmonary exercise test oxygen vs. room air
Time Frame
1 day
Title
Changes in arterial blood parameters (Bicarbonate)
Description
measured during cardiopulmonary exercise test oxygen vs. room air
Time Frame
1 day
Title
muscle tissue oxygen
Description
Oxygen Saturation in the muscle measured with near-infrared spectroscopy oxygen vs. room air
Time Frame
1 day
Title
cerebral tissue oxygen
Description
Oxygen Saturation in the brain measured with near-infrared spectroscopy oxygen vs. room air
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia Ulrich Somaini, Prof. Dr.
Organizational Affiliation
University Hospital Zurich, Division of Pneumology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Division of Pneumology
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34395475
Citation
Muller J, Lichtblau M, Saxer S, Calendo LR, Carta AF, Schneider SR, Berlier C, Furian M, Bloch KE, Schwarz EI, Ulrich S. Effect of Breathing Oxygen-Enriched Air on Exercise Performance in Patients With Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction: A Randomized, Placebo-Controlled, Crossover Trial. Front Med (Lausanne). 2021 Jul 28;8:692029. doi: 10.3389/fmed.2021.692029. eCollection 2021.
Results Reference
derived
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Effect of Short-term Oxygen During CPET in HFpEF
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