Skip to main content
OpenTrials
Completed

NCT Number: NCT04157660

Effect of Short-term Oxygen During CPET in HFpEF

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Failure, Diastolic (HFpEF) Cardiovascular Diseases Heart Diseases Heart Failure Heart Murmurs Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zurich, Division of Pneumology

Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxygen application

Procedure

Oxygen application Supplemental oxygen via mask

Sham room air

Procedure

Room air will be applied via mask

Primary outcomes

  1. Work Rate (Watt)

    Time frame: 1 day

    Maximal Work Rate (Watt max) measured during cardiopulmonary exercise test oxygen vs. room air

  2. Endurance Time (s)

    Time frame: 1 day

    Endurance (s) with 75% Wmax measured during cardiopulmonary exercise test oxygen vs. room air

Secondary outcomes

  1. Peak Oxygen uptake (VO2 max)

    Time frame: 1 day

    measured during cardiopulmonary exercise test oxygen vs. room air

  2. Respiratory Exchange Ratio (RER)

    Time frame: 1 day

    measured during cardiopulmonary exercise test oxygen vs. room air

  3. Changes in arterial blood parameters (pH)

    Time frame: 1 day

    measured during cardiopulmonary exercise test oxygen vs. room air

  4. Changes in arterial blood parameters (PaO2)

    Time frame: 1 day

    measured during cardiopulmonary exercise test oxygen vs. room air

  5. Changes in arterial blood parameters (PaCO2)

    Time frame: 1 day

    measured during cardiopulmonary exercise test oxygen vs. room air

  6. Changes in arterial blood parameters (Lactat)

    Time frame: 1 day

    measured during cardiopulmonary exercise test oxygen vs. room air

  7. Changes in arterial blood parameters (Bicarbonate)

    Time frame: 1 day

    measured during cardiopulmonary exercise test oxygen vs. room air

  8. muscle tissue oxygen

    Time frame: 1 day

    Oxygen Saturation in the muscle measured with near-infrared spectroscopy oxygen vs. room air

  9. cerebral tissue oxygen

    Time frame: 1 day

    Oxygen Saturation in the brain measured with near-infrared spectroscopy oxygen vs. room air

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 8, 2019
Registry last updated
Mar 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.