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

27 Jan 2016

The date of last modification

Jan 29, 2019



Application Summary


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)


Trial Details


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

  1. Age between 18-75 years

  2. 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

  3. Blood pressure >140/90mmHg in patients below 60 years and >150/90mmHg if above 60 years


Exclusion criteria

  1. Systolic blood pressure > 220mmHg requiring immediate adjustments to therapy
  2. Moderate to severe renal insufficiency (acute or chronic) with glomerular filtration rate of less than 30 ml/min ,
  3. Active bronchospastic disorders
  4. Heart failure class III and IV
  5. Severe bradycardia(HR<50bpm)
  6. AV block 2 and 3 degrees
  7. Women who are lactating or pregnant ( a pregnancy test will be carried out during the initial examination)
  8. History of hypersensitivity to any of the drugs under study
  9. Current use of beta blockers


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



State of Ethics Review Approval


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 & Sponsor Information


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

Secondary study sponsor (If any)

None





Trial Completion details


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