Actively Recruiting
The Effects of Dietary Nitrate in Patients With Hypertensive Kidney Injury
Led by Gødstrup Hospital · Updated on 2025-12-18
20
Participants Needed
1
Research Sites
212 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effects of Dietary Nitrate in Patients With Hypertensive Kidney Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Hypertension treated with up to 2 antihypertensive drugs and office blood pressure below 150/95 mmHg at screening, or newly diagnosed without treatment by 24-hour or home blood pressure measurement and unattended office blood pressure below 160/100 mmHg
- Chronic kidney disease stages I to III based on hypertensive kidney injury
- Patients who met CKD I criteria within the last 5 years but no longer have proteinuria after treatment can also join
- Albumin/creatinine ratio less than 500 mg/g
- Estimated glomerular filtration rate above 30 ml/min/1.73 m2
- Body mass index of 35 kg/m2 or less
- Able to adhere to the dietary regimen
- Fertile women must use safe contraception or abstinence; exclusions apply for postmenopausal women without bleeding for 12 months, surgically sterilized women, and women with sterilized partners
You will not qualify if you...
- Diagnosis of heart failure NYHA class II to IV
- Diagnosis of liver failure
- Diabetes mellitus of any type
- Current malignant disease except non-melanoma skin cancer
- Evidence of kidney disease causes other than hypertensive injury
- Previous kidney transplant recipient
- History of stroke or transient cerebral ischemic attack
- Untreated cardiovascular disease or planned ischemia work-up
- History of myocardial infarction except non-STEMI more than 1 year ago if currently treated
- Organic nitrate treatment
- Diagnosed secondary hypertension other than renal parenchymal hypertension
- Pregnancy or breastfeeding
- Alcohol abuse above Danish health guidelines
- Medications that interfere with study measures and cannot be stopped
- Considered unsuitable for participation by the investigator
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Trial Site Locations
Total: 1 location
1
University Clinic in Nephrology and Hypertension, Gødstrup Regional Hospital and Aarhus University
Herning, Denmark, 7400
Actively Recruiting
Research Team
K
Kezia T McWhan, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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