Consequences of chronic kidney disease (CKD) in older people

ISRCTN	ISRCTN84743489
DOI	https://doi.org/10.1186/ISRCTN84743489
Secondary identifying numbers	6258

Submission date: 19/05/2010
Registration date: 19/05/2010
Last edited: 13/12/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Stephen John
Scientific

Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Study information

Study design	Single centre non-randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Cardiovascular and functional consequences of chronic kidney disease in older people: a single centre non-randomised interventional treatment trial
Study objectives	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(s)	Trent MREC, 15/03/2007, ref: 06/MRE04/73
Health condition(s) or problem(s) studied	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
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 study start date	01/08/2007
Completion date	08/02/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Planned sample size: 80
Key inclusion criteria	1. Aged greater than 70 years 2. CKD 3, 4 or hypertensive (greater than 130/80) with no renal disease
Key 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
Date of first enrolment	01/08/2007
Date of final enrolment	08/02/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Royal Derby Hospital

Derby
DE22 3NE
United Kingdom

Sponsor information

Derby Hospital NHS Foundation Trust (UK)
Hospital/treatment centre

Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
England
United Kingdom

Phone	+44 1332 340131
Email	t.grieve@derbyhospitals.nhs.uk
Website	http://www.derbyhospitals.nhs.uk/

Funders

Funder type

Research organisation

British Renal Society (UK)
Private sector organisation / Associations and societies (private and public)

Alternative name(s): BRS
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

13/12/2019: No publications found, verifying study status with principal investigator.
08/08/2016: No publications found in PubMed, verifying study status with principal investigator.