Use of Oxygen in Heart Failure With Preserved Ejection Fraction (STOP-EF)
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Over 50 years of age and able and willing to give consent
- Have signs and/or symptoms of heart failure
- Left ventricular ejection fraction > 45%
- NT-pro BNP > 220 pg/ml (in the previous 12 months)
- On any diuretic
Exclusion Criteria:
- Unable or unwilling to give consent
- Recent (<1 month) acute myocardial infarct or cerebrovascular event
- Significant renal dysfunction (eGFR <30 ml.min-1.1.73m-2)
- Significant anaemia (Haemoglobin < 100 g.L-1)
- Systolic blood pressure <90 mmHg, or >180 mmHg
- Severe mitral or aortic valve disease
- Diagnosis of severe chronic lung disease
- Involvement in another medicinal trial within the past four weeks
- Unable to use cycle
- Any planned admission in the following 3-4 weeks (patient can be reconsidered for enrolment after planned admission)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
21% oxygen
28% oxygen
40% oxygen
Arm Description
room air will be delivered via Venturi mask during cycle ergometry
28% oxygen will be delivered via Venturi mask during cycle ergometry
40% oxygen will be delivered via Venturi mask during cycle ergometry
Outcomes
Primary Outcome Measures
change in exercise time with the use of 21%, 28% and 40% oxygen
the total time cycled in each arm
Secondary Outcome Measures
change in shortness of breath with the use of 21%, 28% and 40% oxygen
shortness of breath measured using BORG score
change in Peak metabolic equivalent with the use of 21%, 28% and 40% oxygen
measured using standard peak metabolic equivalent
Full Information
NCT ID
NCT02949531
First Posted
October 3, 2016
Last Updated
June 24, 2019
Sponsor
Hull University Teaching Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT02949531
Brief Title
Use of Oxygen in Heart Failure With Preserved Ejection Fraction
Acronym
STOP-EF
Official Title
Randomised, Cross Over, Single Blind, Control Trial of Short Term Oxygen Use During Cycle Ergometry in Patients With Chronic Heart Failure With Preserved Ejection Fraction
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
November 3, 2016 (Actual)
Primary Completion Date
February 15, 2017 (Actual)
Study Completion Date
February 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hull University Teaching Hospitals NHS Trust
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Oxygen is routinely given to patients with common conditions such as COPD and heart failure. There is no evidence behind giving oxygen to patients specifically in heart failure due to a stiff heart.
This study aims to explore the effect oxygen has on the ability of patients with chronic heart failure and the ability to exercise. Other common variables will be assessed such as heart rate and blood pressure to observe the response to varying concentrations of oxygen.
The concentrations chosen are commonly offered in hospitals and indeed are being delivered through standard equipment found in all hospitals in the country.
It is hoped that studying the effect of short term oxygen on patients with heart failure will help to identify the effectiveness of oxygen in longer term therapy for patients who are often breathless with a decreased exercise tolerance.
Detailed Description
Many patients with reduced exercise tolerance have a preserved left ventricular function. These patients are labelled as having heart failure with preserved ejection fraction (HeFPEF), when the combined use of echocardiography and biochemistry. The prevalence and the incidence of HeFPEF are on the increase and currently it accounts for around 50% of all patients diagnosed with HF. The last twenty years of research has led to great improvement in available treatments for heart failure with reduced ejection fraction (HeFREF); however, current guidelines only suggest diuretics to improve symptoms of those patients with HeFPEF: clinical trials of several pharmacological interventions have failed to show convincing reductions in morbidity or mortality for patients with HeFPEF.
The effect of oxygen therapy on exercise capacity has remained poorly understood in HeFREF and, at the time of writing this study, it has never been explored in HeFPEF. The investigators recently completed a study showing an increase in exercise time, exercise load at peak exercise and peak metabolic equivalent on cycle ergometry with 28% oxygen supplementation and further increments when 40% oxygen supplementation was used in patients with heart failure with reduced ejection fraction.
The investigators aim to improve exercise time in patients with HeFPEF with oxygen supplementation. Identifying the correct dose of oxygen will be a further aim to avoid hyperoxygenation but provide adequate oxygen to improve exercise tolerance.
Patients will be identified from heart failure clinics and will be invited for screening visit. Eligible patients will have three treatment visit at least one week apart (each visit with a different oxygen concentration i.e room air, 28% and 40% oxygen, randomly determined by sealed envelopes)
Patients will use standard cycle ergometry to exercise and work load will be increased every minute by 5-10 watts. Patients will be encouraged to cycle until tired. At the end of cycling, exercise time, peak metabolic equivalent, work load, shortness of breath score will be noted at each visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
21% oxygen
Arm Type
Active Comparator
Arm Description
room air will be delivered via Venturi mask during cycle ergometry
Arm Title
28% oxygen
Arm Type
Active Comparator
Arm Description
28% oxygen will be delivered via Venturi mask during cycle ergometry
Arm Title
40% oxygen
Arm Type
Active Comparator
Arm Description
40% oxygen will be delivered via Venturi mask during cycle ergometry
Intervention Type
Drug
Intervention Name(s)
oxygen
Primary Outcome Measure Information:
Title
change in exercise time with the use of 21%, 28% and 40% oxygen
Description
the total time cycled in each arm
Time Frame
at 3 weeks
Secondary Outcome Measure Information:
Title
change in shortness of breath with the use of 21%, 28% and 40% oxygen
Description
shortness of breath measured using BORG score
Time Frame
at 3 weeks
Title
change in Peak metabolic equivalent with the use of 21%, 28% and 40% oxygen
Description
measured using standard peak metabolic equivalent
Time Frame
at 3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Over 50 years of age and able and willing to give consent
Have signs and/or symptoms of heart failure
Left ventricular ejection fraction > 45%
NT-pro BNP > 220 pg/ml (in the previous 12 months)
On any diuretic
Exclusion Criteria:
Unable or unwilling to give consent
Recent (<1 month) acute myocardial infarct or cerebrovascular event
Significant renal dysfunction (eGFR <30 ml.min-1.1.73m-2)
Significant anaemia (Haemoglobin < 100 g.L-1)
Systolic blood pressure <90 mmHg, or >180 mmHg
Severe mitral or aortic valve disease
Diagnosis of severe chronic lung disease
Involvement in another medicinal trial within the past four weeks
Unable to use cycle
Any planned admission in the following 3-4 weeks (patient can be reconsidered for enrolment after planned admission)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Clark
Organizational Affiliation
Castle Hill Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29803343
Citation
Shah P, Pellicori P, Rimmer S, Rigby AS, Clark AL. Effect of increased inspired oxygen on exercise performance in patients with heart failure and normal ejection fraction. Int J Cardiol. 2018 Oct 1;268:166-169. doi: 10.1016/j.ijcard.2018.05.029. Epub 2018 May 24.
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Use of Oxygen in Heart Failure With Preserved Ejection Fraction
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