A physiological evaluation of non invasive ventilation (NIV) during exercise in patients with chronic heart failure (CHF).
| ISRCTN | ISRCTN55019674 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55019674 |
| Protocol serial number | N0436130405 |
| Sponsor | Department of Health |
| Funder | Leeds Teaching Hospitals NHS Trust |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 18/03/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr D Schlosshan
Scientific
Scientific
Respiratory Department
Gledhow Wing
Leeds Teaching Hospitals NHS Trust
Beckett Street
Leeds
LS9 7TF
United Kingdom
| Phone | +44 (0)113 243 3144 |
|---|---|
| r&d@leedsth.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A physiological evaluation of non invasive ventilation (NIV) during exercise in patients with chronic heart failure (CHF). |
| Study objectives | To examine the effects of non invasive ventilation (NIV) in patients with CHF on exercise capacity. This study aims to examine the effect of NIV on exercise capacity in patients with CHF, comparing NIV, sham NIV and no ventilatory support. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Chronic heart failure (CHF) |
| Intervention | Randomised controlled trial to examine the effect of NIV on exercise capacity in patients with CHF, comparing NIV, sham NIV and no ventilatory support. |
| Intervention type | Other |
| Primary outcome measure(s) |
Peak oxygen consumption in order to establish the effect of NIV on exercise capacity in patients with CHF. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/02/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | Patients with New York Heart Association (NYHA) class 2 to 4 CHF |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/02/2002 |
| Date of final enrolment | 01/02/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Leeds Teaching Hospitals NHS Trust
Respiratory Department
Gledhow Wing
Beckett Street
Leeds
LS9 7TF
United Kingdom
Gledhow Wing
Beckett Street
Leeds
LS9 7TF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
18/03/2016: No publications found, verifying study status with principal investigator
