Dietary nitrate (beetroot juice) for high blood pressure and hypertensive kidney injury
The Effects of Dietary Nitrate in Patients With Hypertensive Kidney Injury
This study will try beetroot juice (a source of dietary nitrate) to see if it lowers blood pressure and increases kidney blood flow in people with hypertension and early-to-moderate chronic kidney disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Gødstrup Hospital Academic / other |
| Locations | 1 site (Herning) |
| Trial ID | NCT07290842 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with hypertension and hypertensive CKD stage I–III (eGFR >30 mL/min/1.73m2) with albumin/creatinine ratio <500 mg/g, BMI ≤35 kg/m2, on no more than two antihypertensive drugs or newly diagnosed, and able to follow the dietary regimen are ideal candidates.
Not a fit: Patients with advanced kidney failure (eGFR ≤30 mL/min/1.73m2), heavy proteinuria above study limits, BMI over 35, or those unable to adhere to the dietary protocol are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the intervention could lower blood pressure and improve kidney perfusion, leading to better dietary guidance and a simple, nonpharmacologic option for managing hypertensive kidney injury.
How similar studies have performed: Previous small studies in adults have shown that dietary nitrate (often from beetroot juice) can lower blood pressure, but evidence specifically linking nitrate to improved renal blood flow in hypertensive CKD is limited and relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Herning
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.