Use of Oxygen in Heart Failure With Preserved Ejection Fraction

NCT02949531 | Completed Phase 2 DMC

• 1 other identifier: R1965
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• change in exercise time with the use of 21%, 28% and 40% oxygen

  the total time cycled in each arm

  at 3 weeks

Secondary Outcomes (2)

• change in shortness of breath with the use of 21%, 28% and 40% oxygen

  at 3 weeks

• change in Peak metabolic equivalent with the use of 21%, 28% and 40% oxygen

  at 3 weeks

Study Arms (3)

21% oxygen

ACTIVE COMPARATOR

room air will be delivered via Venturi mask during cycle ergometry

Drug: oxygen

28% oxygen

ACTIVE COMPARATOR

28% oxygen will be delivered via Venturi mask during cycle ergometry

Drug: oxygen

40% oxygen

ACTIVE COMPARATOR

40% oxygen will be delivered via Venturi mask during cycle ergometry

Drug: oxygen

Interventions

oxygen DRUG

21% oxygen; 28% oxygen; 40% oxygen

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead

Related Publications (1)

• 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.

  PMID: 29803343 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Andrew Clark

  Castle Hill Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2016
• First Posted: October 31, 2016
• Study Start: November 3, 2016
• Primary Completion: February 15, 2017
• Study Completion: February 15, 2017
• Last Updated: June 26, 2019

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share