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Register:	ISRCTN
Last refreshed on:	5 June 2017
Main ID:	ISRCTN69440037
Date of registration:	31/05/2016
Prospective Registration:	No
Primary sponsor:	Grand Challenges Canada
Public title:	Strategies for improving blood pressure control in Africa
Scientific title:	Physiologically individualized therapy for resistant hypertension in Africa
Date of first enrolment:	03/07/2014
Target sample size:	120
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN69440037
Study type:	Interventional
Study design:	Randomised controlled trial (Prevention)
Phase:	Phase III

Countries of recruitment
Kenya	Nigeria	South Africa

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	J. David Spence
Address:	Robarts Research Institute Western University 1400 Western Road N6G 2V4 London Canada
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria: 1. Blood pressure greater than 160 systolic or 90 diastolic
2.Currently on three medications including a diuretic
3. Attending the hypertension clinic at the study site
4. Aged 18 and over
Exclusion criteria: 1. Renal failure
2. Congestive heart failure
3. Patients with a serious health condition that would limit life expectancy to less than one year

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Resistant hypertension
Circulatory System
Resistant hypertension

Intervention(s)

On the first study visit, participants have blood samples taken for measurement of plasma renin and aldosterone using kits provided by Diagnostics Biochem Canada Inc, and a sample of blood to be sent for DNA extraction and Sanger sequencing to identify genetic factors that may cause salt and water retention.

Patients are randomized using random numbers generated in SPSS, to either the usual care group (in which the plasma renin and aldosterone results are blinded to the physician and the patient) or the physiologically individualized treatment group, in which the plasma renin and aldosterone levels are used to choose the most appropriate therapy. The algorithm used to interpret the plasma renin and aldosterone levels and choose appropriate therapy was described in 2012 (Spence JD. Lessons from Africa: the importance of measuring plasma renin and aldosterone in resistant hypertension. Can J Cardiol. 2012 May;28(3):254-7. PMID: 22289470).

Participants in both groups are followed up for one year in the hypertension clinic, with visits scheduled according to the usual routine in each clinic.

Primary Outcome(s)

Blood pressure control, defined as a systolic pressure <140 mmHg and Diastolic Control is defined as a diastolic pressure <90, is measured using an automated blood pressure device at baseline and one year.

Secondary Outcome(s)

Nucleotide polymorphisms (SNPs) found in the candidate genes are measured using sanger sequencing at baseline in the intervention group only.

Secondary ID(s)

Source(s) of Monetary Support

Grand Challenges Canada

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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