Effect of Short-term Oxygen During CPET in HFpEF

• Sponsor: University of Zurich (Other)
• Overall Status: Completed
• CT.gov ID: NCT04157660
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 2
• Actual Duration (Months): 15.6
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure, Diastolic (HFpEF)	Procedure: Oxygen application; Procedure: Sham room air	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: Effect of Short-term Ambulatory Oxygen Therapy on Cardiopulmonary Exercise Capacity (CPET) in Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)
• Actual Study Start Date: Sep 12, 2019
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Work Rate (Watt) [1 day]

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

2. Endurance Time (s) [1 day]

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

Secondary Outcome Measures

1. Peak Oxygen uptake (VO2 max) [1 day]

   measured during cardiopulmonary exercise test oxygen vs. room air

2. Respiratory Exchange Ratio (RER) [1 day]

   measured during cardiopulmonary exercise test oxygen vs. room air

3. Changes in arterial blood parameters (pH) [1 day]

   measured during cardiopulmonary exercise test oxygen vs. room air

4. Changes in arterial blood parameters (PaO2) [1 day]

   measured during cardiopulmonary exercise test oxygen vs. room air

5. Changes in arterial blood parameters (PaCO2) [1 day]

   measured during cardiopulmonary exercise test oxygen vs. room air

6. Changes in arterial blood parameters (Lactat) [1 day]

   measured during cardiopulmonary exercise test oxygen vs. room air

7. Changes in arterial blood parameters (Bicarbonate) [1 day]

   measured during cardiopulmonary exercise test oxygen vs. room air

8. muscle tissue oxygen [1 day]

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

9. cerebral tissue oxygen [1 day]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Zurich, Division of Pneumology	Zürich		Switzerland	8091

Sponsors and Collaborators

• University of Zurich

Investigators

• Principal Investigator: Silvia Ulrich Somaini, Prof. Dr., University Hospital Zurich, Division of Pneumology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Zurich
• ClinicalTrials.gov Identifier: NCT04157660
• Other Study ID Numbers: KEK-ZH-NR. 2012-0251_3
• First Posted: Nov 8, 2019
• Last Update Posted: Mar 12, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Heart Failure; Heart Failure, Diastolic

Study Results

No Results Posted as of Mar 12, 2021