Condition category
Circulatory System
Date applied
24/06/2015
Date assigned
25/06/2015
Last edited
17/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
High blood pressure (hypertension) affects over 1 billion people and, due to its effects on blood vessels, contributes to causes of death worldwide more than any other factor. The risk can be lowered in these patients by reducing blood pressure to target (i.e. recommended) levels set by experts. However, despite the potential benefit to their health, less than half of people treated reach their blood pressure targets. Previous research has shown that the number of patients achieving these goals can be increased by clinics following a clear treatment plan. It has also been shown that early reduction of blood pressure in these patients improves long term health. We aim to show that these findings can be combined using an innovative treatment plan to reduce blood pressure quickly in newly-diagnosed patients with severe hypertension to prove that this is safe and works well. Using this new treatment plan, the study will explore if it is possible to predict whether blood pressure treatment will work before medications are started. Patients will have both non-invasive and simple blood tests to determine their blood vessel and heart structure and function at their first visit. It is hoped that this will help tailor blood pressure treatment to individual patients’ needs in the future.

Who can participate?
Adults aged 18-79 recently diagnosed with severe hypertension.

What does the study involve?
All participants receive nurse-led treatment of their hypertension according to a detailed protocol and in-line with current NICE and ESC guidance. This includes 10 visits over an 18-week period in which treatment may be altered depending on individual tolerance and efficacy (how well it works). Before treatment has started, participants have non-invasive tests of their heart and blood vessel structure and function to determine if the results can predict response to treatment. Following completion of the study, participants are discharged to their GP with an ongoing plan for continuing care, or follow-up in the NHS specialist hypertension clinic, depending on clinical need.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
Royal Devon & Exeter Hospital, NIHR Exeter Clinical Research Facility MRI Suite and Patient identification centres run by the Devon Partnership NHS Trust (UK)

When is the study starting and how long is it expected to run for?
June 2015 to November 2016

Who is funding the study?
Gawthorn Cardiac Trust (UK)

Who is the main contact?
Dr Andrew Jordan

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrew Jordan

ORCID ID

http://orcid.org/0000-0002-4428-6499

Contact details

Royal Devon & Exeter Hospital (Wonford)
Diabetes and Vascular Health Research Centre
Royal Devon & Exeter Hospital
Barrack Road
Exeter
EX2 5DW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

19176

Study information

Scientific title

Understanding the barriers to successful treatment of newly diagnosed severe hypertension: an interventional study

Acronym

DASHER

Study hypothesis

A study exploring whether a new nurse-led treatment protocol can successfully treat patients with a new diagnosis of severe hypertension within 18 weeks, whilst examining the reasons for failure to achieve blood pressure goals in this cohort.

Ethics approval

NRES Committee South West – Cornwall & Plymouth, 17/04/2015, ref: 15/SW/0077

Study design

Interventional

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Topic: Cardiovascular disease; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular Prevention

Intervention

All participants will receive nurse-led treatment of newly-diagnosed severe hypertension according to a detailed protocol and in-line with current NICE and ESC guidance. This includes 10 visit over an 18-week period in which treatment may be altered depending on individual tolerance and efficacy. Before treatment has started, participants will have non-invasive tests of their heart and cardiac and microvascular structure and function to determine if these parameters can predict response to treatment. Following completion of the study, participants will be discharged to their primary care practitioner with an ongoing plan for continuing care, or follow-up in the NHS specialist hypertension clinic, depending on clinical need.

Intervention type

Other

Phase

Phase II

Drug names

Primary outcome measures

The proportion of patients with a new diagnosis of severe hypertension who achieve a BP target of <140/90 at 18 weeks.

Secondary outcome measures

1. The proportion of patients not reaching target BP who are found to be non-adherent to treatment using directly observed therapy (DOT) and urinary panel testing
2. The incidence of secondary causes of hypertension in the patient cohort
3. Relationship between baseline physiological parameters and success in achieving BP target
4. Proportion of patients enrolled discontinuing the protocol before week 18 and incidence of adverse events during study participation (tolerability)
5. The median number of weeks needed to achieve target blood pressure in the study population
6. Change in CMR findings after successful treatment of severe hypertension as compared to patients in whom treatment is unsuccessful in achieving target BP

Overall trial start date

23/06/2015

Overall trial end date

07/11/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. New diagnosis of severe hypertension with systolic blood pressure greater than or equal to 170mmHg on screening and when repeated by the study team using the standard operating procedure for blood pressure measurement
2. No present or historical anti-hypertensive agent prescription
3. Aged 18-79 years inclusive

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 100; UK Sample Size: 100

Participant exclusion criteria

1. Inability to give informed consent
2. Significant renal dysfunction as defined by eGFR <60 ml/min/1.73m2 by Modification of Diet in Renal Disease Study (MDRD) formula
3. Previous or current prescription of any medication used in the study protocol
4. Previous renal artery intervention
5. Bleeding diathesis
6. Haemoglobin <10 g/dl
7. Platelet count <100 x109/l
8. Inability to provide informed consent
9. Pregnancy
10. Hypertension related event (including stroke or acute kidney injury) within the preceding 3 months.
11. Any condition, including hypertensive urgency, which requires more immediate BP lowering or tailored anti-hypertensive strategy at enrolment

Recruitment start date

23/06/2015

Recruitment end date

07/11/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Devon & Exeter Hospital (Wonford) - lead site
Diabetes and Vascular Health Research Centre Royal Devon & Exeter Hospital Barrack Road
Exeter
EX2 5DW
United Kingdom

Trial participating centre

NIHR Exeter Clinical Research Facility MRI Suite
St Luke's Campus University of Exeter
Exeter
EX1 2LU
United Kingdom

Trial participating centre

Devon Partnership NHS Trust
Patient identification centres (PICs)
Exeter
-
United Kingdom

Sponsor information

Organisation

Royal Devon & Exeter Hospital

Sponsor details

Cancer Clinical Trials
Cherrybrook Ward
Cancer Clinical Trials
Room S142
Barrack Road
Exeter
EX2 5DW
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Gawthorn Cardiac Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The investigators will be involved in reviewing drafts of the manuscripts, abstracts, press releases and any other publications arising from the study, the details of which will depend on the study results. Authorship will be determined in accordance with the ICMJE guidelines and other contributors will be acknowledged. Participants will be given access to the final published findings of the study on request. Time will be allocated for publication and dissemination of results at the end of the study period (March-November 2016).

Intention to publish date

01/11/2016

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes