Effect of Short-term Oxygen During CPET in HFpEF
Effect of Short-term Ambulatory Oxygen Therapy on Cardiopulmonary Exercise Capacity (CPET) in Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2019
CompletedStudy Start
First participant enrolled
September 12, 2019
CompletedFirst Posted
Study publicly available on registry
November 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedMarch 12, 2021
March 1, 2021
1.3 years
August 30, 2019
March 11, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (9)
Peak Oxygen uptake (VO2 max)
1 day
Respiratory Exchange Ratio (RER)
1 day
Changes in arterial blood parameters (pH)
1 day
Changes in arterial blood parameters (PaO2)
1 day
Changes in arterial blood parameters (PaCO2)
1 day
- +4 more secondary outcomes
Study Arms (2)
Supplemental oxygen
EXPERIMENTALSupplemental oxygen will be applied via a mask during CPET
Sham room air
SHAM COMPARATORRoom air will be applied similarly to oxygen
Interventions
Eligibility Criteria
You may qualify if:
- HFpEF, stable medication for at least 4 weeks.
You may not qualify if:
- instable status, pregnancy, clinically relevant concomitant diseases, inability to follow the study procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Zurich, Division of Pneumology
Zurich, 8091, Switzerland
Related Publications (1)
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.
PMID: 34395475DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Silvia Ulrich Somaini, Prof. Dr.
University Hospital Zurich, Division of Pneumology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2019
First Posted
November 8, 2019
Study Start
September 12, 2019
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
March 12, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share