Ignite Creation Date:
2024-05-06 @ 9:16 AM
Last Modification Date:
2024-10-26 @ 12:12 PM
Study NCT ID:
NCT02949531
Status:
COMPLETED
Last Update Posted:
2019-06-26
First Post:
2016-10-03
Brief Title:
Use of Oxygen in Heart Failure With Preserved Ejection Fraction
Sponsor:
Hull University Teaching Hospitals NHS Trust
Organization:
Hull University Teaching Hospitals NHS Trust
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STOP-EF
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
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 ie 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
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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None