Contact information
Type
Scientific
Primary contact
Dr D Schlosshan
ORCID ID
Contact details
Respiratory Department
Gledhow Wing
Leeds Teaching Hospitals NHS Trust
Beckett Street
Leeds
LS9 7TF
United Kingdom
+44 (0)113 243 3144
r&d@leedsth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436130405
Study information
Scientific title
A physiological evaluation of non invasive ventilation (NIV) during exercise in patients with chronic heart failure (CHF).
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Peak oxygen consumption in order to establish the effect of NIV on exercise capacity in patients with CHF.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/02/2002
Overall trial end date
01/02/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Patients with New York Heart Association (NYHA) class 2 to 4 CHF
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/02/2002
Recruitment end date
01/02/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Leeds Teaching Hospitals NHS Trust
Respiratory Department
Gledhow Wing
Beckett Street
Leeds
LS9 7TF
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Leeds Teaching Hospitals NHS Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary