Consequences of chronic kidney disease (CKD) in older people
| ISRCTN | ISRCTN84743489 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84743489 |
| Protocol serial number | 6258 |
| Sponsor | Derby Hospital NHS Foundation Trust (UK) |
| Funder | British Renal Society (UK) |
- 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
Scientific
Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre non-randomised interventional treatment trial |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant 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(s) |
Changes in Baroreflex sensitivity (a composite marker of autonomic function) in response to antihypertensive therapy, assessed at each assessment |
| Key secondary outcome measure(s) |
Assessed at each assessment: |
| Completion date | 08/02/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Royal Derby Hospital
Derby
DE22 3NE
United Kingdom
DE22 3NE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
