Condition category
Circulatory System
Date applied
09/08/2017
Date assigned
11/08/2017
Last edited
09/08/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Having high blood pressure increases the chances that a person will suffer a heart attack or stroke in the future. The aim of treating high blood pressure with medication is to reduce this risk. A number of different types of medication are known to be effective in reducing blood pressure and in reducing the risk of heart attack and stroke. One of these medication types is the diuretics, often referred to as “water-tablets”. There are two diuretics commonly used in the UK for the treatment of high blood pressure but we do not know which is better. We know that they both work but one may be more effective than the other in the long term. The EVIDENCE (Evaluating Diuretics in Normal Care) study aims to find out if one of these medications is better than the other at preventing heart attacks and strokes. In everyday practice, GP's and hospital doctors are guided by agreed policies, based upon the best available evidence, in deciding which medications are likely to be the most effective. This study aims to compare the effectiveness of two different prescribing policies for diuretics in preventing heart attacks and strokes.

Who can participate?
Patients aged 18 and older who are diagnosed with a thiazide, or thiazide-like diuretic to treat hypertension.

What does the study involve?
Participating GPs are randomly assigned to one of these two prescribing policies. The doctors within that practice then use that policy to guide their prescribing decisions. As already happens in the NHS, mechanisms for switching from one medication to another is used to help practices adhere to their prescribing policy. GP's and their patients are free to choose what they think is the most appropriate treatment in each individual case. People who are registered in practices taking part in the study have their blood pressure medication managed by their GP in the usual way. If the practice policy requires a change to a patient’s usual diuretic prescription, participants are sent a letter advising them that this will take effect on their next requested prescription. All such patients will be given the opportunity to decline the switch. Participants are followed up with for the cardiovascular outcomes.

What are the possible benefits and risks of participating?
As the two medications in question are currently thought to be effectively the same in terms of benefits and side effects, there will be no direct risk or benefit to a person whose GP practice is taking part in the study.

Where is the study run from?
Medicines Monitoring Unit, University of Dundee (UK)

When is the study starting and how long is it expected to run for?
October 2017 to October 2020

Who is funding the study?
University of Dundee (UK)

Who is the main contact?
Dr Amy Rogers
arogers@dundee.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Amy Rogers

ORCID ID

http://orcid.org/0000-0001-5207-7032

Contact details

Medicines Monitoring Unit
University of Dundee
Medical School
Dundee
DD1 9SY
United Kingdom
+44 1382 383390
arogers@dundee.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol number: 2016CV12

Study information

Scientific title

EValuatIng DiurEtics in Normal CarE (EVIDENCE) - a cluster randomised evaluation of hypertension prescribing policy

Acronym

EVIDENCE

Study hypothesis

The aim of this study is to formally evaluate the effectiveness of a policy of prescribing bendroflumethiazide versus a policy of prescribing indapamide as first-line choice of thiazide/thiazide-like diuretic in the treatment of hypertension.

Ethics approval

East of Scotland Research Ethics Service (EoSRES), 04/01/2017, ref: 17/ES/0016

Study design

Two-arm cluster randomised study of prescribing policy

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Hypertension and cardiovascular risk

Intervention

There are two study arms. Practices are randomly assigned on a 1:1 basis (using a computer algorithm) to either of two prescribing policies:

1. A policy of using Bendroflumethiazide (2.5mg, oral, once daily) as first choice when a diuretic is required for the treatment of hypertension

2. A policy of using Indapamide (2.5mg, immediate release, oral, once daily) as first choice when a diuretic is required for the treatment of hypertension

Individual treatment decisions regarding drug choice, dosage, method and frequency of administration for patients will be left up to the treating GPs.

Where patients are already taking thiazide, or thiazide-like, diuretics at the time a practice joins the study, routine repeat prescriptions will be switched to the policy preferred drug, unless clinically indicated.

Intervention type

Other

Phase

Drug names

Primary outcome measures

The composite cardiovascular outcome (comprising non-fatal MI, non-fatal stroke, hospitalization for congestive heart failure, and vascular death) is measured using electronic record-linkage to national datasets of routinely collected data and supported by information from medical records.

Secondary outcome measures

1. Each individual component of the composite primary outcome will be included as a secondary outcome
2. All-cause mortality is measured using record-linkage to national datasets of routinely collected data

The study is primary outcome driven so the outcomes are counted as they occur rather than at defined time periods. We expect that the follow-up process will take around 3 years to accrue sufficient events to power the study.

Overall trial start date

21/03/2017

Overall trial end date

01/03/2021

Reason abandoned

Eligibility

Participant inclusion criteria

1. Registered patients with a documented diagnosis of hypertension and prescribed a thiazide, or thiazide-like, diuretic in a participating practice
2. Aged 18 and older

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

215 GP practices of typical size (including approximately 240 individuals prescribed diuretics for hypertension)

Participant exclusion criteria

Not meeting the inclusion criteria.

Recruitment start date

01/10/2017

Recruitment end date

01/10/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Medicines Monitoring Unit
University of Dundee Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom

Sponsor information

Organisation

University of Dundee/NHS Tayside

Sponsor details

TASC (Tayside Medical Science Centre)
Ninewells Hospital & Medical School
TASC Research & Development Office
Residency
Block
Level 3
George Pirie Way
Dundee
DD1 9SY
United Kingdom
+44 1382 383140
ahsp@dundee.ac.uk

Sponsor type

University/education

Website

http://www.ahspartnership.org.uk/ahsp

Funders

Funder type

Research council

Funder name

Medicines Monitoring Unit University of Dundee

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We will publish the study protocol (where possible) and will undertake to make public the study results. The major form of publication will be articles in scientific journals but presentations and press releases may also be made. Protocol and statistical analysis plan will be made available at a later date.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/10/2021

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes