Condition category
Circulatory System
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
18/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes

18/03/2016: No publications found, verifying study status with principal investigator