Does the underlying haemodynamic abnormality determine response to antihypertensive therapy?
| ISRCTN | ISRCTN56916002 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56916002 |
| Clinical Trials Information System (CTIS) | 2006-006981-40 |
| Protocol serial number | 5293 |
| Sponsor | Cambridge University Hospitals NHS Foundation Trust (UK) |
| Funder | British Heart Foundation (BHF) (UK) |
- 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
Scientific
Addenbrookes Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre randomised interventional treatment trial |
| Secondary study design | Randomised controlled trial |
| Study type | 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Doxazosin, bisoprolol, candesartan, isosorbide mononitrate |
| Primary outcome measure(s) |
Difference in BP change according to pre-specified group analysis. |
| Key secondary outcome measure(s) |
1. Change in haemodynamic parameters achieved by different study medication |
| Completion date | 01/08/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Addenbrookes Hospital
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2014 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
04/08/2016: Publication reference added.
