Diagnosing and treating severe hypertension

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN57475376

Enrollment

100

Registered

2015-06-25

Start date

2015-06-23

Completion date

Unknown

Last updated

2022-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Cardiovascular disease

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026