Home » Trials » SLCTR/2016/002
Addition of Propranolol in Resistant Arterial Hypertension Treatment - A randomized clinical trial
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SLCTR Registration Number
SLCTR/2016/002
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
Addition of Propranolol in Resistant Arterial Hypertension Treatment - A randomized clinical trial
Public Title of Trial
The effectiveness of propranolol in difficult to control blood pressure - a randomized trial
Disease or Health Condition(s) Studied
Resistant hypertension
Scientific Acronym
APROPRIATE trial
Public Acronym
None
Brief title
Propranolol in resistant hypertension
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
EC-15-152 (Ethics Review Committee of the Faculty of Medicine, University of Colombo)
What is the research question being addressed?
What is the effect of add-on propranolol compared to placebo in patients with resistant hypertension?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 3
Intervention(s) planned
The study will be carried out at medical clinics of the National Hospital of Sri Lanka. Consenting patients meeting inclusion/exclusion criteria will be randomized into two arms.
Intervention arm
Participants will receive an add-on dose of Propranolol 40 mg three times daily. They will be assessed once a month and the dose increased up to 80mg three times daily. Intervention will be carried out for a total duration of three months.
Control arm
Participants will receive an identical placebo to be taken 3 times daily for a period of 3 months.
Participants in both arms will continue their usual treatment regimens.
Inclusion criteria
Age between 18-75 years
Resistant hypertension is defined as casual blood pressure during clinical examination of more than 140/90 mmHg (a mean of the 2nd and 3rd measurements during a single examination, at least 3 min apart) despite treatment with a multidrug combination consisting of a diuretic and ACEI/ARB, centrally acting drug, alpha blocker or calcium channel blocker
Blood pressure >140/90mmHg in patients below 60 years and >150/90mmHg if above 60 years
Exclusion criteria
Primary outcome(s)
|
1.
Blood pressure measured by ABPM (ambulatory blood pressure monitoring) |
[ At baseline and three months ] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
120
Countries of recruitment
Sri Lanka
Anticipated start date
2016-02-01
Anticipated end date
2017-02-01
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
National Research Council, Sri Lanka (Grant number 15-070)
Regulatory approvals
Status
Approved
Date of Approval
2015-10-15
Approval number
EC-15-152
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. G.R. Constantine
Consultant Cardiologist and Senior Lecturer in Medicine
Faculty of Medicine, University of Colombo
Tel: 011 2 695300
Mob: 0777575683
grogerconstantine@gmail.com
Contact Person for Public Queries
Dr. G.R. Constantine
Consultant Cardiologist and Senior Lecturer in Medicine
Faculty of Medicine, University of Colombo
Tel: 011 2 695300
Mob: 0777575683
grogerconstantine@gmail.com
Primary study sponsor/organization
National Research Council, Sri Lanka
380/97,Baudhdhaloka Mawatha Sarana Rd, Colombo
011 2 695060
Fax: +94 11 267 5136
Web: www.nrc.gov.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
