Table 1 World Health Organization Trial Registration Data Set Checklist

Primary registry and trial identifying number

ClinicalTrials.gov: NCT02283697

Date of registration in primary registry

4 November 2014

Secondary identifying numbers

-

Source(s) of monetary or material support

The Ottawa Hospital Academic Medical Organisation

Primary sponsor

The Ottawa Hospital Academic Medical Organisation

Secondary sponsor(s)

Ottawa Hospital Research Institute

Contact for public queries

Gigi van den Hoef +16137985555 ext 82514

Contact for scientific queries

Marcel Ruzicka, MD PhD

Swapnil Hiremath, MD MPH

Public title

Sodium counselling in hypertension

Scientific title

Does Pragmatically Structured Outpatient Dietary Counselling Reduce Sodium Intake in Hypertensive Patients?

Countries of recruitment

Canada

Health condition(s) or problem(s) studied

Hypertension

Intervention(s)

Active comparator: standard of care + Dietitian lead counselling

Control comparator: standard of care

Key inclusion and exclusion criteria

Inclusion criteria:

- adult patients (>18 years) with

- hypertension defined as daytime blood pressure (BP) readings above 140/90 mmHg (as assessed from 24-hour ambulatory BP monitoring (ABPM)) without treatment

- and/or any patient with treated hypertension irrespective of BP load based on 24-hour ABPM.

Exclusion criteria:

- Pregnant patients (since pregnancy and hypertension requires different dietary advice)

Patients with following conditions:

- eGFR <45 ml/min/1.75 m²,

- active infection (defined as being on active anti-microbial treatment),

- recent acute coronary syndrome (myocardial infarction or revascularisation) within 6 months,

- psychiatric disorders and/or otherwise unable to sign consent,

- patients with clinically manifested generalized and/or cardiac volume overload (including ascites and congestive heart failure) who may require immediate changes in diuretic therapy (at the discretion of treating hypertension specialist).

- Inability to provide informed consent

Study type

Interventional

Allocation: randomized

Intervention model: parallel assignment

Masking: blinding of outcomes assessor only

Primary purpose: treatment

Date of first enrolment

June 2015 (anticipated)

Target sample size

120

Recruitment status

Funded, approved, enrolment to begin soon

Primary outcome(s)

Change in 24-hour urinary sodium from baseline at 4 weeks and 12 months

Key secondary outcomes

Changes in 24-hour urinary potassium, body weight, and BP