Condition category
Circulatory System
Date applied
26/09/2005
Date assigned
26/09/2005
Last edited
25/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gilles Soulez

ORCID ID

Contact details

CHUM-Notre-Dame
Département de Radiology
1560 rue Sherbrooke Est
Montréal
H2L 4M1
Canada
+1 514 890 8000 ext. 26522
gilles.soulez.chum@ssss.gouv.qc.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCT-52685

Study information

Scientific title

The role of angioplasty after selecting patients according to the doppler resistive index: a randomised controlled trial

Acronym

Study hypothesis

Medical treatment and renal angioplasty in renovascular hypertension

Ethics approval

Comite d'ethique de la recherche, Hopital Notre Dame, Centre Hospitalier de L'universite de Montreal (CHUM), Montreal, Québec approved on 14th May 2002.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Renovascular hypertension

Intervention

Added 25/02/2009: the study was terminated early due to recruitment issue.

Inclusion of patients presenting a controlled hypertension with 2 or 3 antihypertensive drugs and risk factors for renovascular hypertension. Selection on Doppler inclusion criteria (Resistive index less than 0.75) and renal angiography renal artery stenosis of more than 60% in diameter.

Group 1: Medical treatment (duration: 12 months)
Group 2: Renal angioplasty

Follow up for one year following angioplasty.

Trial details received: 12 Sept 2005

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Systolic and diastolic blood pressure 12 months post-randomisation

Secondary outcome measures

1. Blood pressure at 1 and 6 months post-randomisation
2. Clinical success on blood pressure control at 12 months
3. Serum creatine clearance when off antihypertensive drugs during 12 months? Does it mean that you have no control over those?
4. Morbidity related to cardiovascular events during follow-up
5. Incidence of renal artery restenosis

Overall trial start date

01/09/2002

Overall trial end date

30/03/2006

Reason abandoned

Participant recruitment issue

Eligibility

Participant inclusion criteria

1. Hypertension greater than 140/90 mmHg with two hypertensive drugs
2. Hypertension less than 140/90 mmHg with three antihypertensive drugs
3. Aged greater than or equal to 30 years old, either sex
4. Atherosclerotic renal artery stenosis of more than 60% on catheter angiography or 70% on computed tomography (CT) or magnetic resonance (MR) angiography
5. Doppler resistive index less than 0.75

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant exclusion criteria

1. Creatinine clearance less than 30 ml/min
2. Non controlled hypertension (greater than 160/105 mmHg) despite 3 anti-hypertensive drugs
3. Renal artery stenosis greater than 95%
4. Fibromuscular dysplasia

Recruitment start date

01/09/2002

Recruitment end date

30/03/2006

Locations

Countries of recruitment

Canada

Trial participating centre

CHUM-Notre-Dame
Montréal
H2L 4M1
Canada

Sponsor information

Organisation

Hospital Notre-Dame (Montréal) (Canada)

Sponsor details

1560 rue Sherbrooke Est
Montréal
H2L 4M1
Canada

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-52685)

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

2005 cost-benefit analysis results in http://www.ncbi.nlm.nih.gov/pubmed/15728620

Publication citations

  1. Bolduc JP, Oliva VL, Therasse E, Giroux MF, Bouchard L, Perreault P, Cliché A, Soulez G, Diagnosis and treatment of renovascular hypertension: a cost-benefit analysis., AJR Am J Roentgenol, 2005, 184, 3, 931-937, doi: 10.2214/ajr.184.3.01840931.

Additional files

Editorial Notes