Condition category
Circulatory System
Date applied
12/05/2010
Date assigned
12/05/2010
Last edited
04/08/2016
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

Mrs Michaela Watts

ORCID ID

Contact details

Addenbrookes Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Additional identifiers

EudraCT number

2006-006981-40

ClinicalTrials.gov number

Protocol/serial number

5293

Study information

Scientific title

Does the underlying haemodynamic abnormality determine response to antihypertensive therapy?

Acronym

Rotation Study

Study hypothesis

The purpose of the study/trial is to find out the relation of haemodynamic abnormalities in 60 patients with hypertension and their responses to different classes of antihypertensive agents.

Ethics approval

MREC approved, ref: 07/Q0108/33

Study design

Single-centre randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular

Intervention

Patients will be enrolled and the following data is collected:
1. History
2. Physical examination
3. Height
4. Weight
5. Blood tests
6. Electrocardiogram (ECG)
7. Haemodynamic measurements

Administration of medications will be in a double-blind randomised placebo controlled cross-over methodology: doxazosin 1 - 4 mg, bisoprolol 2.5 - 5 mg, candesartan 8 - 16 mg, isosorbide mononitrate M/R 25 - 50 mg

There will be 42 days per treatment phase and 36 weeks in total.

Intervention type

Drug

Phase

Not Applicable

Drug names

Doxazosin, bisoprolol, candesartan, isosorbide mononitrate

Primary outcome measures

Difference in BP change according to pre-specified group analysis.

Secondary outcome measures

1. Change in haemodynamic parameters achieved by different study medication
2. Number of patients reaching target BP

Overall trial start date

01/06/2007

Overall trial end date

01/08/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Hypertensive patients

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 60

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/06/2007

Recruitment end date

01/08/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Addenbrookes Hospital
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

Addenbrookes Hospital
Box 277
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Sponsor type

Government

Website

http://www.cuh.org.uk/research/research_index.html

Funders

Funder type

Charity

Funder name

British Heart Foundation (BHF) (UK)

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2014 results in: http://www.sciencedirect.com/science/article/pii/S1872931214000581

Publication citations

Additional files

Editorial Notes

04/08/2016: Publication reference added.