Condition category
Circulatory System
Date applied
09/10/2007
Date assigned
18/12/2007
Last edited
18/12/2007
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

Prof Hans Herlitz

ORCID ID

Contact details

Department of Nephrology
Sahlgrenska University Hospital
Göteborg
413 45
Sweden
+46 31 3428477
hans.herlitz@medic.gu.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

S 131-03

Study information

Scientific title

Acronym

CARLAS

Study hypothesis

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

Approved by the Ethical Committees of the Universities of Göteborg and Lund on the 14th of April 2003.

Study design

A two-center randomized controlled open study.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Not Specified

Patient information sheet

Condition

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 names

Candesartan

Primary outcome measures

Renal function measured by EDTA-clearance and frequency of restenosis 3 years after PTRA.

Secondary outcome measures

Cardiovascular events 3 years after PTRA.

Overall trial start date

15/04/2003

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

200

Participant 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

Recruitment start date

15/04/2003

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Sweden

Trial participating centre

Department of Nephrology
Göteborg
413 45
Sweden

Sponsor information

Organisation

AstraZeneca (Sweden)

Sponsor details

Argongatan 2D
Mölndal
431 86
Sweden
+46 31 7788500
mikael.forsby@astrazeneca.com

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

The Ernhold Lundström Foundation (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Research Funds at Malm General (University) Hospital (Malm Allmnna Sjukhus - MAS) (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Albert Påhlsson Foundation (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Hulda Ahlmroth Foundation (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Göteborg Medical Society (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Swedish Medical Society

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Swedish Association for Kidney Patients

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

AstraZeneca, Mölndal (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Swedish state under the LUA/ALF agreement

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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