ISRCTN ISRCTN57475376
DOI https://doi.org/10.1186/ISRCTN57475376
Secondary identifying numbers 19176
Submission date
24/06/2015
Registration date
25/06/2015
Last edited
07/03/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Andrew Jordan
Scientific

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

ORCiD logoORCID ID 0000-0002-4428-6499

Study information

Study designInterventional
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleUnderstanding the barriers to successful treatment of newly diagnosed severe hypertension: an interventional study
Study acronymDASHER
Study objectivesA 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(s)NRES Committee South West – Cornwall & Plymouth, 17/04/2015, ref: 15/SW/0077
Health condition(s) or problem(s) studiedTopic: Cardiovascular disease; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular Prevention
InterventionAll 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 typeOther
Primary outcome measureThe proportion of patients with a new diagnosis of severe hypertension who achieve a BP target of <140/90 at 18 weeks.
Secondary outcome measures1. 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 study start date23/06/2015
Completion date07/11/2016

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit79 Years
SexBoth
Target number of participantsPlanned Sample Size: 100; UK Sample Size: 100
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment23/06/2015
Date of final enrolment07/11/2016

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

Royal Devon & Exeter Hospital (Wonford) - lead site
Diabetes and Vascular Health Research Centre
Royal Devon & Exeter Hospital
Barrack Road
Exeter
EX2 5DW
United Kingdom
NIHR Exeter Clinical Research Facility MRI Suite
St Luke's Campus
University of Exeter
Exeter
EX1 2LU
United Kingdom
Devon Partnership NHS Trust
Patient identification centres (PICs)
Exeter
-
United Kingdom

Sponsor information

Royal Devon & Exeter Hospital
Hospital/treatment centre

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

ROR logo "ROR" https://ror.org/03jrh3t05

Funders

Funder type

Charity

Gawthorn Cardiac Trust (UK)

No information available

Results and Publications

Intention to publish date01/11/2016
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planThe 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).
IPD sharing planThe current data sharing plans for this study are unknown and will be available at a later date

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 25/10/2021 26/10/2021 Yes No
Other publications 04/03/2022 07/03/2022 Yes No
HRA research summary 28/06/2023 No No

Editorial Notes

07/03/2022: Publication reference added.
26/10/2021: Publication reference added.
30/05/2019: Internal review.