Home » Trials » SLCTR/2016/002


Addition of Propranolol in Resistant Arterial Hypertension Treatment - A randomized clinical trial -

SLCTR Registration Number

SLCTR/2016/002


Date of Registration

27 Jan 2016

The date of last modification

Jan 27, 2016



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 of Health Condition(s) Studied

Resistant hypertension


Scientific Acronym

APROPRIATE trial


Public Acronym

None


Brief title

Propranolol in resistant hypertension


Universal Trail Number

None


Any other number(s) assigned to the trial and issuing authority

ERC approval number: EC-15-152


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


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)

Blood pressure measured by ABPM (ambulatory blood pressure monitoring)


Primary outcome(s) - Time of assessment(s)

At baseline and three months


Secondary outcome

None


Secondary outcome(s) - Time of assessment(s)

None



Target number/sample size

120


Countries of recruitment

Sri Lanka


Anticipated start date

2016-02-01


Anticipated end date

2017-02-01


Recruitment status

Pending


State of ethics review approval

Approved by the Ethics Review Committee of the Faculty of Medicine, University of Colombo on 15.10.2015 (ref: EC-15-152)


Funding source

National Research Council, Sri Lanka (Grant number 15-070)



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