Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
6258
Study information
Scientific title
Cardiovascular and functional consequences of chronic kidney disease in older people: a single centre non-randomised interventional treatment trial
Acronym
Study hypothesis
The aim of this study is to investigate this area with an integrated range of non-invasive assessments, both without antihypertensive medication, and with BP control to published best-practice guidelines.
Ethics approval
Trent MREC, 15/03/2007, ref: 06/MRE04/73
Study design
Single centre non-randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Non 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: Renal and Urogenital; Subtopic: Renal and Urogenital (all Subtopics); Disease: Renal
Intervention
Antihypertensive therapy using standard agents to target BP 130/80 mmHg. Assessments are performed after antihypertensive washout, reintroduction and 12 months follow up.
Intervention type
Other
Phase
Phase IV
Drug names
Primary outcome measure
Changes in Baroreflex sensitivity (a composite marker of autonomic function) in response to antihypertensive therapy, assessed at each assessment
Secondary outcome measures
Assessed at each assessment:
1. Cardiovascular predictors of Falls propensity
2. Cardiovascular consequences of antihypertensive therapy
Overall trial start date
01/08/2007
Overall trial end date
08/02/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged greater than 70 years
2. CKD 3, 4 or hypertensive (greater than 130/80) with no renal disease
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 80
Participant exclusion criteria
1. Use of more than 3 drugs for blood pressure control
2. Likely to develop CKD 5 within one year
3. Poor mobility precluding completion of assessment
4. Diabetes
5. Abbreviated mental test (AMT) score < 8
6. Recent acute illness (within 3 months)
7. Ischaemic heart disease requiring beta-blockade (nitrates/nicorandil are permitted)
8. Involvement in another clinical trial within 3 months
9. Attending day hospital or attending falls reduction services
10. Residents in nursing or residential homes
11. Renovascular disease precluding ACE-inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) usage
12. BP prior to antihypertensive withdrawal > 160/90mmHg
13. Malignant hypertension
14. Severe peripheral vascular disease or significant valvular heart disease
15. Heart failure (NYHA III/IV) or other cause to prevent diuretic withdrawal
16. Atrial fibrillation or other significant arrhythmia (precludes pulse wave velocity (PWV) measurement)
17. Currently taking antihypertensive medication for which MRHA approval (CTA) has not been granted
18. Active Obstructive uropathy
Recruitment start date
01/08/2007
Recruitment end date
08/02/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Derby Hospital
Derby
DE22 3NE
United Kingdom
Sponsor information
Organisation
Derby Hospital NHS Foundation Trust (UK)
Sponsor details
Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
+44 1332 340131
t.grieve@derbyhospitals.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Research organisation
Funder name
British Renal Society (UK)
Alternative name(s)
BRS
Funding Body Type
private sector organisation
Funding Body Subtype
professional associations and societies
Location
United Kingdom
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
Basic results (scientific)
Publication list