The Effects of Dietary Nitrate in Patients With Hypertensive Kidney Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorGødstrup Hospital
About this trial
The study aims to study the effects of diatery nitrate in patients with hypertension and hypertensive kidney injury.
The study is a randomized, placebo-controlled, double-blinded crossover trial. 14-20 patients with hypertension and CKD I-III will be randomized to receive either nitrate or placebo delivered in the form of beetroot juice.
Effect variables will be measured before and after a 2 week treatment. After a washout period of 14 days, the subjects are crossed over to the opposite treatment.
The study is terminated by measuring effect variables after the second treatment period.
Eligibility criteria
Qualifiers
Hypertension, treated with a maximum of 2 antihypertensive drugs and unattended office BP < 150/95 mmHg at the screening visit, or newly diagnosed without antihypertensive treatment by 24-hour BP or home BP measurement (above 130/80 or 135/85 respectively), and unattended office BP < 160/100 mmHg.
CKD I-III based on hypertensive kidney injury. Patients, who previously met the criteria for CKD I within the last 5 years, but no longer has proteinuria after relevant treatment, can also be included. Diagnosis of CKD I can be based on eGFR and either urine albumin/creatine ration or urine-dipstick test with presence of protein.
Albumin/creatinine ratio < 500 mg/g
eGFR > 30 ml/min/1,73m2
Disqualifiers
• Diagnosis of heart failure, NYHA II-IV
Diagnosis of liver failure
Diabetes mellitus (all types)
Current malignant disease (other than non-melanoma skin cancer)
Trial design
Treatments tested in this trial
- Beetroot Juice - Active
- Beetroot juice placebo
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov