The effect of oxygen on exercise performance in chronic heart failure

• Conditions: Chronic heart failure; MedDRA version: 17.0Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-003380-38-GB
• Lead Sponsor: R&D department, Hull and East Yorkshire Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-15
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patients must:
•Be over 18 and able and willing to give consent
•Have symptomatic heart failure on medical therapy
•Be able to use an ergometer safely
•Have impaired left ventricular systolic function (at least moderate” on echocardiography or left ventricular ejection fraction <40% by any technique)
•Abstain from alcohol, caffeine and nicotine 12 hours before the study.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

Exclusion Criteria:
•Unable or unwilling to give consent
•Recent (<1 month) acute myocardial infarct or cerebrovascular event
•Severe renal impairment (eGFR <20 ml.min-1.1.73m-2)
•Haemoglobin < 90 g.L-1 or haematocrit <45%
•Systolic blood pressure <80 mmHg
•Diagnosis of chronic lung disease
•Involvement in another medicinal trial within the past four weeks

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified