Does the underlying haemodynamic abnormality determine response to antihypertensive therapy?

ISRCTN	ISRCTN56916002
DOI	https://doi.org/10.1186/ISRCTN56916002
EudraCT/CTIS number	2006-006981-40
Secondary identifying numbers	5293

Submission date: 12/05/2010
Registration date: 12/05/2010
Last edited: 04/08/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Michaela Watts
Scientific

Addenbrookes Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Study information

Study design	Single-centre randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Does the underlying haemodynamic abnormality determine response to antihypertensive therapy?
Study acronym	Rotation Study
Study objectives	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(s)	MREC approved, ref: 07/Q0108/33
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Doxazosin, bisoprolol, candesartan, isosorbide mononitrate
Primary outcome measure	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 study start date	01/06/2007
Completion date	01/08/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Planned sample size: 60
Key inclusion criteria	Hypertensive patients
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/06/2007
Date of final enrolment	01/08/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Addenbrookes Hospital

Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Cambridge University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

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

Website	http://www.cuh.org.uk/research/research_index.html
"ROR"	https://ror.org/04v54gj93

Funders

Funder type

Charity

British Heart Foundation (BHF) (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): the_bhf, The British Heart Foundation, BHF
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2014		Yes	No

Editorial Notes

04/08/2016: Publication reference added.