Renovascular hypertension: the role of angioplasty after selecting patients according to the doppler resistive index
| ISRCTN | ISRCTN40816134 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40816134 |
| Secondary identifying numbers | 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
Scientific
CHUM-Notre-Dame
Département de Radiology
1560 rue Sherbrooke Est
Montréal
H2L 4M1
Canada
| Phone | +1 514 890 8000 ext. 26522 |
|---|---|
| gilles.soulez.chum@ssss.gouv.qc.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 01/09/2002 |
| Completion date | 30/03/2006 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
H2L 4M1
Canada
Sponsor information
Hospital Notre-Dame (Montréal) (Canada)
Hospital/treatment centre
Hospital/treatment centre
1560 rue Sherbrooke Est
Montréal
H2L 4M1
Canada
"ROR" |
https://ror.org/01w7qz648 |
|---|
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-52685)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
