Effect of Short-term Oxygen During CPET in HFpEF

March 11, 2021 updated by: University of Zurich

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zürich, Switzerland, 8091
        • University Hospital Zurich, Division of Pneumology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2019

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

August 30, 2019

First Submitted That Met QC Criteria

November 7, 2019

First Posted (Actual)

November 8, 2019

Study Record Updates

Last Update Posted (Actual)

March 12, 2021

Last Update Submitted That Met QC Criteria

March 11, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK-ZH-NR. 2012-0251_3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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