Heart FailurePhase 2STOP-EFNCT02949531
Use of Oxygen in Heart Failure With Preserved Ejection Fraction
A Phase 2 study testing oxygen in people with Heart Failure, run by Hull University Teaching Hospitals NHS Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 3 Nov 2016to 15 Feb 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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)
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- oxygen
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxygenDrug
| Study group | Role | What they receive |
|---|---|---|
| 21% oxygen | Active comparator | room air will be delivered via Venturi mask during cycle ergometry Receives: Drug: oxygen |
| 28% oxygen | Active comparator | 28% oxygen will be delivered via Venturi mask during cycle ergometry Receives: Drug: oxygen |
| 40% oxygen | Active comparator | 40% oxygen will be delivered via Venturi mask during cycle ergometry Receives: Drug: oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in exercise time with the use of 21%, 28% and 40% oxygen
the total time cycled in each arm
Measured: at 3 weeks
Secondary outcomes (2)
change in shortness of breath with the use of 21%, 28% and 40% oxygen
shortness of breath measured using BORG score
Measured: at 3 weeks
change in Peak metabolic equivalent with the use of 21%, 28% and 40% oxygen
measured using standard peak metabolic equivalent
Measured: at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study start3 Nov 2016
- Primary completion15 Feb 2017
- Study completion15 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Andrew Clark, Principal investigator, Castle Hill Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949531
- Sponsor's protocol ID
- R1965
- Acronym
- STOP-EF
- Status last verified
- Sep 2016
- First submitted
- 3 Oct 2016
- Last updated
- 26 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 29803343
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02949531
- Acronym / sponsor ID
- STOP-EF / R1965
- Conditions
- Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Study start
- 3 Nov 2016 (actual)
- Primary completion
- 15 Feb 2017 (actual)
- Study completion
- 15 Feb 2017 (actual)
- First posted
- 31 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 21% oxygen | Active comparator | Drug: oxygenroom air will be delivered via Venturi mask during cycle ergometry |
| 28% oxygen | Active comparator | Drug: oxygen28% oxygen will be delivered via Venturi mask during cycle ergometry |
| 40% oxygen | Active comparator | Drug: oxygen40% oxygen will be delivered via Venturi mask during cycle ergometry |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxygen | Drug | 21% oxygen, 28% oxygen, 40% oxygen |
Primary outcome
change in exercise time with the use of 21%, 28% and 40% oxygen
Time frame: at 3 weeks
the total time cycled in each arm
2 secondary outcomes
change in shortness of breath with the use of 21%, 28% and 40% oxygen
Time frame: at 3 weeks
change in Peak metabolic equivalent with the use of 21%, 28% and 40% oxygen
Time frame: at 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
- Background: PubMed 29803343Shah 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.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Clark principal investigator
Castle Hill Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oxygen in people with Heart Failure, run by Hull University Teaching Hospitals NHS Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in exercise time with the use of 21%, 28% and 40% oxygen (time frame: at 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02949531, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2019.