Condition category
Circulatory System
Date applied
12/05/2010
Date assigned
12/05/2010
Last edited
19/11/2013
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 TF Antonios

ORCID ID

Contact details

Blood Presure Unit
Cranmer Terrace
London
SW17 0RE
United Kingdom

Additional identifiers

EudraCT number

2008-005432-32

ClinicalTrials.gov number

Protocol/serial number

6830

Study information

Scientific title

Effects of an angiotensin receptor antagonist candesartan versus a calcium channel blocker amlodipine on microvascular rarefaction, endothelial dysfunction, and microalbuminuria in essential hypertension

Acronym

CAMIRA

Study hypothesis

Many 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

London-Surrey Borders Research Ethics Committee approved on the 19/11/2008 (ref: 08/H0806/72)

Study design

Single centre randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Intervention

After 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 type

Drug

Phase

Phase IV

Drug names

Candesartan, amlodipine

Primary outcome measures

The increase in maximal capillary density at the end of 8 weeks treatment.

Secondary outcome measures

1. 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 trial start date

01/02/2010

Overall trial end date

01/10/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 46

Participant exclusion criteria

1. 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)

Recruitment start date

01/02/2010

Recruitment end date

01/10/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Blood Presure Unit
London
SW17 0RE
United Kingdom

Sponsor information

Organisation

St George's, University of London (UK)

Sponsor details

Cranmer Terrace
London
SW17 0RE
United Kingdom

Sponsor type

University/education

Website

http://www.sgul.ac.uk

Funders

Funder type

Industry

Funder name

Takeda UK Limited (UK)

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