Condition category
Urological and Genital Diseases
Date applied
19/05/2010
Date assigned
19/05/2010
Last edited
08/08/2016
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 Stephen John

ORCID ID

Contact details

Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom

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 measures

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

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

http://www.derbyhospitals.nhs.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

08/08/21016: No publications found in PubMed, verifying study status with principal investigator.