Status:
COMPLETED
Dietary Counseling or Potassium Supplement to Increase Potassium Intake in Patients With High Blood Pressure
Lead Sponsor:
Ottawa Hospital Research Institute
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
High blood pressure is the leading cause of cardiovascular disease worldwide. Many medicines are available to lower blood pressures successfully, as well as many non-medical options, such as dietary c...
Detailed Description
High blood pressure is the leading cause of cardiovascular disease worldwide, including in Canada. The prevalence of high blood pressure is steadily rising, with growing and ageing population. Many me...
Eligibility Criteria
Inclusion
- Provides signed and dated informed consent form
- Diagnosis of hypertension (either on treatment; or not on treatment with an ambulatory blood pressure monitor (ABPM)- daytime systolic blood pressure (SBP) \> 140 or diastolic blood pressure (DBP) \> 90)
- Male or female, aged 18 and greater (women of child bearing potential must use highly effective contraception (e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants; intrauterine device (IUD) or intrauterine system (IUS); vasectomy of male partner and tubal ligation)
- 24-Hour Urine K \< 60 mmol/day
Exclusion
- Serum Potassium \< 3.3 or \> 5.1 mmol/L
- Glomerular Filtration Rate \< 45 ml/min/1.73m2
- Primary hyperaldosteronism
- Pregnancy or lactation
- Psychiatric disorder which, in the opinion of the investigator, would interfere with the study, or inability to give consent
- Severe Liver disease
- Metabolic Alkalosis (HCO3 \> 32 mmol/L)
- Exclude patients who need to be started on renin-angiotensin-aldosterone blockade in the first 3 months
- Gastrointestinal disorder (e.g. delayed gastric emptying, dysphagia, oesophageal/gastric/duodenal ulcer)
- Presence of cardiac disease (sever myocardial damage, heart failure, or clinical changes in congestive heart failure, ejection fraction \<35%)
- Uncontrolled diabetes mellitus (HbA1C \>12%)
- Acute dehydration
- Extensive tissue damage (burns)
- Increased hypersensitivity to potassium (e.g. paramyotonia congenital or adynamia episodica hereditaria)
- Patients taking other potassium supplements for another indication (eg. kidney stones)
- Acidosis (pH\<7.11)
- Adrenal insufficiency
- Allergies to any of the investigational product ingredients (medicinal and non- medicinal)
- Patients on any of the following medications should be on a stable dose: angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor blockers, beta-blockers, mineralocorticoid receptor antagonists, amiloride, non steroidal antiinflammatory drugs (NSAIDs), beta-blockers, digoxin, and heparin
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2024
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03809884
Start Date
December 1 2019
End Date
July 22 2024
Last Update
April 9 2025
Active Locations (1)
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1
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 1A2