Use of Oxygen in Heart Failure With Preserved Ejection Fraction (STOP-EF)

June 24, 2019 updated by: Hull University Teaching Hospitals NHS Trust

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

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

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 21% oxygen
room air will be delivered via Venturi mask during cycle ergometry
Drug: oxygen
Active Comparator: 28% oxygen
28% oxygen will be delivered via Venturi mask during cycle ergometry
Drug: oxygen
Active Comparator: 40% oxygen
40% oxygen will be delivered via Venturi mask during cycle ergometry
Drug: oxygen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in shortness of breath with the use of 21%, 28% and 40% oxygen
Time Frame: at 3 weeks
shortness of breath measured using BORG score
at 3 weeks
change in Peak metabolic equivalent with the use of 21%, 28% and 40% oxygen
Time Frame: at 3 weeks
measured using standard peak metabolic equivalent
at 3 weeks

Collaborators and Investigators

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

Sponsor

Hull University Teaching Hospitals NHS Trust

Investigators

  • Principal Investigator: Andrew Clark, Castle Hill Hospital

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

Helpful Links

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)

November 3, 2016

Primary Completion (Actual)

February 15, 2017

Study Completion (Actual)

February 15, 2017

Study Registration Dates

First Submitted

October 3, 2016

First Submitted That Met QC Criteria

October 27, 2016

First Posted (Estimate)

October 31, 2016

Study Record Updates

Last Update Posted (Actual)

June 26, 2019

Last Update Submitted That Met QC Criteria

June 24, 2019

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R1965

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

Clinical Trials on Heart Failure

Clinical Trials on oxygen

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe