Combined effects of potassium, nitrate and sodium on blood pressure in patients with hypertensio

Phase 1

• Conditions: Essential Hypertension; MedDRA version: 20.0Level: PTClassification code 10020772Term: HypertensionSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2021-003407-17-DK
• Lead Sponsor: niversity Clinic of Nephrology and Hypertension

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-24
• Last Update Posted: 25 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

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 < 500 mg/g
Safe contraception if women in childbearing age
eGFR > 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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): Additional 24-hour blood pressure measurements: Diastolic blood pressure, day and night time blood pressure, nocturnal blood pressure decrease.<br>Systemic hemodynamics: central blood pressure, heart frequency, pulse wave velocity and vascular stiffness.<br>Salt-blood test<br>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.<br>Plasma levels of sodium, potassium, creatinine, uric acid, nitrite, nitrate, ANP, cGMP, aldosterone, renin, angiotensin II, BNP and vasopressin. <br>Plasma levels of IL-1B, IL-6, IL-10, IL-17A and IFN-y.<br>;Timepoint(s) of evaluation of this end point: At the end of the study, when all participants have completed the trial