Dietary nitrate (beetroot juice) for high blood pressure and hypertensive kidney injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, placebo-controlled, double-blinded crossover study enrolling 14–20 adults with hypertension and CKD stages I–III related to hypertensive kidney injury. Participants receive beetroot juice containing dietary nitrate or a placebo for two weeks, followed by a 14-day washout, then cross over to the opposite treatment. Outcome measures are taken before and after each treatment period and include 24-hour blood pressure monitoring, renal clearance using Tc-99m DTPA, and water-based PET/CT for renal blood flow. The design compares short-term physiological effects of nitrate versus placebo within the same participants.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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
  * Body Mass Index (BMI) ≤ 35 kg/m2
  * Able to adhere to dietary regimen
  * Fertile women must use safe contraception (oral contraceptive pill, hormonal or copper intrauterine device, vaginal ring, contraceptive implant, transdermal contraceptive patch or contraceptive injections) or abstinence. Excluded from this are postmenopausal woman without menstrual bleeding for at least 12 months before inclusion, surgically sterilized women and women with surgically sterilized partner.

Exclusion Criteria:

* • Diagnosis of heart failure, NYHA II-IV

  * Diagnosis of liver failure
  * Diabetes mellitus (all types)
  * Current malignant disease (other than non-melanoma skin cancer)
  * Indicators of other aetiologies of CKD than hypertensive kidney injury, e.g. through kidney biopsy or biochemistry.
  * Previous kidney transplant recipient
  * History of stroke or transient cerebral ischemic attack
  * Current indication of untreated cardiovascular disease, e.g. planned work-up for ischemia.
  * History of myocardial infarction, apart from non-STEMI more than 1 year prior to the study, if the subject is currently revascularized and relevantly medicated.

Organic nitrate treatment Diagnosed secondary hypertension other than renal parenchymal hypertension (i.e. renal artery stenosis, primary hyperaldosteronism, low renin hypertension etc.)

* Pregnancy or lactation
* Alcohol abuse (intake above the recommended guidelines from Danish Health Authorities)
* Conditions treated with medication that investigator finds may interfere with the effect parameters, and cannot be discontinued during the trial (e.g. atrial fibrillation treated with betablockers)
* If, according to the investigator's assessment, the participant is considered unsuitable to participate.

Where it's running

• University Clinic in Nephrology and Hypertension, Gødstrup Regional Hospital and Aarhus University
  Herning, Denmark Recruiting

Study contacts

• Study coordinator: Kezia T McWhan, MD
• Email: kezmcw@rm.dk
• Phone: 004578436580

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.