Diagnosing and treating severe hypertensio

Phase 2

Completed

• Conditions: Topic: Cardiovascular disease; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular Prevention; Circulatory System

• Registration Number: ISRCTN57475376
• Lead Sponsor: Royal Devon & Exeter Hospital

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34689818/ (added 26/10/2021) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/35246164/ (added 07/03/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-25
• Study Completion: 2016-11-07
• Last Update Posted: 21 March 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
<br> 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<br> 2. The incidence of secondary causes of hypertension in the patient cohort<br> 3. Relationship between baseline physiological parameters and success in achieving BP target<br> 4. Proportion of patients enrolled discontinuing the protocol before week 18 and incidence of adverse events during study participation (tolerability)<br> 5. The median number of weeks needed to achieve target blood pressure in the study population<br> 6. Change in CMR findings after successful treatment of severe hypertension as compared to patients in whom treatment is unsuccessful in achieving target BP<br>