Chronic heart failure MedDRA version: 17.0 Level: LLT Classification code 10008908 Term: Chronic heart failure System Organ Class: 100000004849
Conditions
Interventions
Trade Name: Medical Oxygen inhalation gas
Product Name: Medical Oxygen
Product Code: PL 17872/0002
Pharmaceutical Form: Emulsion for injection
INN or Proposed INN: Oxygen (International Non Propriety
Sponsors
R&D department, Hull and East Yorkshire Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does short-term oxygen affect exercise capacity in patients with chronic heart failure? ;Secondary Objective: To assess the effect oxygen administration has on oxygen saturation, heart rate, blood pressure and ease of exercise in patients with chronic heart failure.;Primary end point(s): Exercise capacity;Timepoint(s) of evaluation of this end point: Participants will undergo three exercise sessions, one for each oxygen concentration. In total each session is aimed to last between 8-12 minutes whilst receiving oxygen once weekly over three consecutive weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Symptoms during exercise;Timepoint(s) of evaluation of this end point: Symptoms during exercise will be evaluated by the participant. It will be emphasised that participants should stop when they feel that their symptoms are significant to ensure safety and good quality data. The exercise sessions are aimed to last between 8-12 minutes. | — |
Countries
United Kingdom
Contacts
Public ContactProfessor Andrew Clark
Academic Cardiology department
Outcome results
None listed