Renovascular hypertension: the role of angioplasty after selecting patients according to the doppler resistive index

ISRCTN	ISRCTN40816134
DOI	https://doi.org/10.1186/ISRCTN40816134
Protocol serial number	MCT-52685
Sponsor	Hospital Notre-Dame (Montréal) (Canada)
Funder	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-52685)

Submission date: 26/09/2005
Registration date: 26/09/2005
Last edited: 25/02/2009

Recruitment status: Stopped
Overall study status: Stopped
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

Dr Gilles Soulez
Scientific

CHUM-Notre-Dame
Département de Radiology
1560 rue Sherbrooke Est
Montréal
H2L 4M1
Canada

Phone	+1 514 890 8000 ext. 26522
Email	gilles.soulez.chum@ssss.gouv.qc.ca

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	The role of angioplasty after selecting patients according to the doppler resistive index: a randomised controlled trial
Study objectives	Medical treatment and renal angioplasty in renovascular hypertension
Ethics approval(s)	Comite d'ethique de la recherche, Hopital Notre Dame, Centre Hospitalier de L'universite de Montreal (CHUM), Montreal, Québec approved on 14th May 2002.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Systolic and diastolic blood pressure 12 months post-randomisation
Key secondary outcome measure(s)	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
Completion date	30/03/2006
Reason abandoned (if study stopped)	Participant recruitment issue

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	120
Key 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
Key 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
Date of first enrolment	01/09/2002
Date of final enrolment	30/03/2006

Locations

Countries of recruitment

Canada

Study participating centre

CHUM-Notre-Dame

Montréal
H2L 4M1
Canada

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?
Results article	cost-benefit analysis results	01/03/2005		Yes	No