Essential Hypertension MedDRA version: 20.0 Level: PT Classification code 10020772 Term: Hypertension System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Trade Name: Kaliumklorid "Orifarm"
Product Name: Kaliumklorid "Orifarm"
Pharmaceutical Form: Tablet
INN or Proposed INN: Potassium chloride
CAS Number: 7447-40-7
Other descriptive name: Kaliumchlorid
Sponsors
University Clinic of Nephrology and Hypertension
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Males or females, =18 years Body mass index = 35 kg/m2 Essential hypertension (current treatment with a maximum of 3 antihypertensive drugs or newly diagnosed) Capable of adhering to a dietary regimen Albumin-to-creatinine-ratio 60 ml/min/1,73m2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: Secondary hypertension Clinically significant heart failure (NYHA 3-4) Diabetes mellitus (type 1 and 2) Clinically significant liver disease Current malignant disease (other than skin cancer) Renal transplant Recent stroke, transient ischemic attack or myocardial infarction (past 6 months) Immunosuppressive treatment Pregnancy or lactation Alcohol abuse Nitroglycerin or slow-release nitrate treatment Treatment with other medications that might interact with results and which cannot be paused during the intervention due to safety reasons. CKD due to other cause than hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is investigating the effect of dietary potassium, nitrate and salt on blood pressure in patients with essential hypertension ;Secondary Objective: To examine thee physiological mechanisms involved in changes in blood pressure after dietary intervention such as sodium and water balance, central hemodynamics, vasoactive hormones, tubular sodium transporters, changes in the immune system and endothelial function;Primary end point(s): Change in systolic 24-hour blood pressure;Timepoint(s) of evaluation of this end point: At the end of the study, when all participants have completed the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Additional 24-hour blood pressure measurements: Diastolic blood pressure, day and night time blood pressure, nocturnal blood pressure decrease. Systemic hemodynamics: central blood pressure, heart frequency, pulse wave velocity and vascular stiffness. Salt-blood test 24 hour urin collection, separated into day and night time for measuring: sodium, potassium, nitrite, nitrate, uric acid, creatinine, osmolality, albumin and the tubular sodium channels ENaC and NCC as well as AQP2. Plasma levels of sodium, potassium, creatinine, uric acid, nitrite, nitrate, ANP, cGMP, aldosterone, renin, angiotensin II, BNP and vasopressin. Plasma levels of IL-1B, IL-6, IL-10, IL-17A and IFN-y. ;Timepoint(s) of evaluation of this end point: At the end of the study, when all participants have completed the trial | — |
Countries
Denmark
Contacts
Public ContactCamilla Lundgreen Duus
University Clinic of Nephrology and Hypertension
Outcome results
None listed