Effects of an ARB on microcirculation in essential hypertension

ISRCTN ISRCTN62554526
DOI https://doi.org/10.1186/ISRCTN62554526
EudraCT/CTIS number 2008-005432-32
Secondary identifying numbers 6830
Submission date
12/05/2010
Registration date
12/05/2010
Last edited
24/01/2019
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

Dr Tarek F Antonios
Scientific

Blood Presure Unit
St George's University
Cranmer Terrace
London
SW17 0RE
United Kingdom

Study information

Study designSingle centre randomised interventional treatment trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEffects of an angiotensin receptor antagonist candesartan versus a calcium channel blocker amlodipine on microvascular rarefaction, endothelial dysfunction, and microalbuminuria in essential hypertension
Study acronymCAMIRA
Study objectivesMany abnormalities are known to occur in the microcirculation in essential hypertension including reduction in vascular density or rarefaction. Capillary rarefaction is not confined to the skin but represents a widespread phenomenon affecting several tissues in hypertensive individuals including the myocardium, the kidneys and the brain resulting in reducing coronary blood flow reserve, and precipitating heart failure in cardiac hypertrophy. In this study we aim to investigate, in a double-blind randomised design, the effects of treating hypertension with an angiotensin receptor blocker versus a calcium antagonist on the reversibility of capillary rarefaction.

On 19/11/2013 the anticipated end date was changed from 01/10/2011 to 01/10/2014.
Ethics approval(s)London-Surrey Borders Research Ethics Committee, 19/11/2008, ref: 08/H0806/72
Health condition(s) or problem(s) studiedTopic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular
InterventionAfter a 2-week single-blind placebo run-in period, patients will be randomised to 8 weeks treatment with either candesartan 8 mg once daily orally (with forced titration to 16 mg once daily orally after 2 weeks) or amlodpine 5 mg once daily orally (with forced titration to 10 mg once daily orally after 2 wks).

Study entry: single randomisation only
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase IV
Drug / device / biological / vaccine name(s)Candesartan, amlodipine
Primary outcome measureThe increase in maximal capillary density at the end of 8 weeks treatment.
Secondary outcome measures1. Change in aortic augmentation index at 8 weeks
2. Change in basal capillary density at 8 weeks
3. Reduction in microalbuminuria at 8 weeks
4. Improvement in pulse wave velocity at 8 weeks
Overall study start date01/02/2010
Completion date01/10/2014

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned sample size: 46
Key inclusion criteria1. Male and female, aged 18 years or older
2. Uncomplicated mild-to-moderate essential hypertension, i.e., sitting diastolic blood pressure (BP) greater than or equal to 90 to less than 110 mmHg and/or systolic BP greater than or equal to 140 to less than 180 mmHg)
3. Not previously treated for their high blood pressure
4. Caucasian and light-coloured Asians only, this is due to the technical difficulty of performing capillaroscopy in dark-skinned individuals
Key exclusion criteria1. Malignant or accelerated hypertension
2. Serum creatinine greater than 180 µmol/L
3. Ischaemic heart disease
4. Cerebrovascular disease
5. Impaired liver functions
6. Diabetes mellitus
7. Pregnancy or risk of pregnancy
8. Lactation
9. History of alcoholism, drug abuse or other problems that are likely to invalidate the informed consent
10. Dark-skinned individuals (capillary microscopy can't be performed)
Date of first enrolment01/02/2010
Date of final enrolment01/10/2014

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Blood Presure Unit
Blood Presure Unit
St George's University
Cranmer Terrace
London
SW17 0RE
United Kingdom

Sponsor information

St George's, University of London (UK)
University/education

Cranmer Terrace
London
SW17 0RE
England
United Kingdom

Website http://www.sgul.ac.uk
ROR logo "ROR" https://ror.org/040f08y74

Funders

Funder type

Industry

Takeda UK Limited (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 14/11/2017 24/01/2019 Yes No
HRA research summary 28/06/2023 No No

Editorial Notes

24/01/2019: Publication reference added
20/01/2017: No publications found in PubMed, verifying study status with principal investigator.