Candesartan in renal artery stenosis (CARLAS)
| ISRCTN | ISRCTN35143689 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35143689 |
| Protocol serial number | S 131-03 |
| Sponsor | AstraZeneca (Sweden) |
| Funders | The Ernhold Lundström Foundation (Sweden), Research Funds at Malm General (University) Hospital (Malm Allmnna Sjukhus - MAS) (Sweden), The Albert Påhlsson Foundation (Sweden), The Hulda Ahlmroth Foundation (Sweden), The Göteborg Medical Society (Sweden), The Swedish Medical Society, The Swedish Association for Kidney Patients, AstraZeneca, Mölndal (Sweden), The Swedish state under the LUA/ALF agreement |
- Submission date
- 09/10/2007
- Registration date
- 18/12/2007
- Last edited
- 18/12/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
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
Prof Hans Herlitz
Scientific
Scientific
Department of Nephrology
Sahlgrenska University Hospital
Göteborg
413 45
Sweden
| Phone | +46 31 3428477 |
|---|---|
| hans.herlitz@medic.gu.se |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | A two-center randomized controlled open study. |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | CARLAS |
| Study objectives | Despite beneficial effects on blood pressure with endovascular treatment, the prognosis remains ominous in patients with renal artery stenosis because of increased cardiovascular mortality. In patients with atherosclerotic renal artery stenosis, the mortality is increased six-fold compared to an age-matched population. It is reasonable to speculate that the high cardiovascular mortality in patients with renal artery stenosis could partly be explained by increased inflammatory activity caused by activation of the renin-angiotensin system. We believe that Percutaneous Transluminal Renal Angioplasty (PTRA) followed by angiotensin receptor blockade may improve this disease state. The angiotensin receptor blocker candesartan given to patients with renovascular hypertension post-PTRA, will improve long-term renal function (3 years) and decrease the risk of restenosis. |
| Ethics approval(s) | Approved by the Ethical Committees of the Universities of Göteborg and Lund on the 14th of April 2003. |
| Health condition(s) or problem(s) studied | Renal artery stenosis |
| Intervention | This study is carried out at two centers in Sweden (Göteborg and Malmö). Four weeks after renal angioplasty, all subjects will be randomized to anti-hypertensive treatment with either candesartan (oral) (intervention group) or conventional anti-hypertensive treatment (control group). The choice of drug used for the treatment of each participant in the control group will depend on his/her condition. The choices are betablockers, calcium antagonists, diuretics and alphablockers. The maximum daily doses: 200 mg for metoprolol (betablocker), 20 mg for felodipine (calcium antagonist), as much as needed for furosemide (diuretic), 8 mg for doxazosin (alphablocker). Candesartan was titrated up to a dose of 16 mg once daily. Duration of intervention: three years |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Candesartan |
| Primary outcome measure(s) |
Renal function measured by EDTA-clearance and frequency of restenosis 3 years after PTRA. |
| Key secondary outcome measure(s) |
Cardiovascular events 3 years after PTRA. |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 200 |
| Key inclusion criteria | 1. Blood pressure above 140 mmHg/90 mmHg 2. Confirmation of renal artery stenosis by either duplex ultrasonography, CT-angiography or MR-angiography |
| Key exclusion criteria | 1. Renal size <7.5 cm at the stenotic side 2. Age >80 years 3. Pregnancy or nursing mother 4. Terminal renal failure (Glomerular Filtration Rate [GFR] <15 ml/min) 5. Treatment with Angiotensin-Converting Enzyme (ACE) inhibitors or angiotensin receptor blockers 6. Renovascular hypertension of other etiology than atherosclerosis or Flow-Mediated Dilation (FMD) 7. Chronic glomerular disease with urinary albumin excretion (in mg/24h) (tU-alb) >1g/day 8. Diabetic nephropathy with tU-alb >0.3 g/day 9. Contraindication for renal angiography/PTRA (eg. serious contrast allergy) 10. Other forms of secondary hypertension 11. Serious malignant disease 12. Treatment with immune-modulating medications eg. cyclosporin and oral steroids |
| Date of first enrolment | 15/04/2003 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Department of Nephrology
Göteborg
413 45
Sweden
413 45
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
