Monotherapy Versus Dual Therapy for Initial Treatment for Hypertension — Pathway 1  

Essential Hypertension Clinical Trial

Official title: Monotherapy Versus Dual Therapy for Initial Treatment for Hypertension

Status Recruiting

Clinical Trial Summary

To test whether the current custom of initiating treatment for hypertension with a single drug is less effective in the short-term than initial combination therapy, and results in the eventual need for comparatively more antihypertensive drug therapy.

Clinical Trial Description

To determine if patients randomised to more aggressive (combination therapy) treatment for the initial treatment of hypertension have better blood pressure control compared to those randomised to less aggressive (monotherapy) treatment despite subsequent add-on treatment being similar in each group. This will test the hypothesis that monotherapy patients 'never catch up' with combination therapy patients.

1. To determine if this 'never catch-up' phenomenon of improved BP control persists for at least one year.

2. To understand the underlying mechanism of improved BP control; specifically:

1. To determine if it is due to haemodynamic compensation, such as increased sodium retention and volume expansion.

2. To determine if it is due to increased peripheral resistance.

3. To understand the predictors of BP control i.e. age, baseline renin status, sodium status and plasma volume.

4. To validate the National Institute for Clinical Excellence / British Hypertension Society joint guideline ACD algorithm by comparing BP control in the monotherapy crossover arm of phase 1 and to correlate this with age (≤ 55 or > 55y), and baseline characteristics such as renin.

5. To determine the safety and tolerability of a strategy of prescribing combination therapy as the initial step versus monotherapy as the initial step. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Vasospasm
• Essential Hypertension
• Hypertension
• Hypertension, Resistant to Conventional Therapy

• NCT number: NCT00994617
• Study type: Interventional
• Source: University of Cambridge
• Contact: Professor Morris Brown, FMedSCI
• Phone: +44 (0)1223 336743
• Email: mjb14@hermes.cam.ac.uk
• Status: Recruiting
• Phase: Phase 4
• Start date: January 2010
• Completion date: December 2014