The Effects of Dietary Nitrate in Patients With Hypertensive Kidney Injury

NCT07290842 | Recruiting

• 1 other identifier: KTM-1-2025
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Hypertension; CKD - Chronic Kidney Disease

Keywords

nitrate; hypertension; beetroot

Outcome Measures

Primary Outcomes (1)

• Changes in 24 h systolic blood pressure

  Measured by Mobiograph

  Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)

Secondary Outcomes (19)

• Diastolic blood pressure

  Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)

• Heart rate

  Measured on 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)

• Pulsewave velocity

  Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)

• Augmentation index

  Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)

• Vascular resistance

  Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)

Study Arms (2)

Beetroot juice (active)

ACTIVE COMPARATOR

nitrate content: 400 mg

Dietary Supplement: Beetroot Juice - Active

Beetroot juice (placebo)

PLACEBO COMPARATOR

nitrate free

Dietary Supplement: Beetroot juice placebo

Interventions

Beetroot Juice - Active DIETARY_SUPPLEMENT

Intervention is beetroot juice ("Beet It concentrated beetroot juice shots", James White Drinks Ltd, Ipswich, England) The nitrate content of the juice is standardized. The dose of nitrate will be 70 ml/day corresponding to intake of 6.5 mmol/400 mg of nitrate.

Beetroot juice (active)

Beetroot juice placebo DIETARY_SUPPLEMENT

The placebo beetroot juice is a corresponding nitrate free beetroot juice, obtained from the manufacturer ("Beet It nitrate depleted shots", James White Drinks Ltd, Ipswich, England.). The placebo juice appears identical to the nitrate containing juice regarding color and taste.

Beetroot juice (placebo)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gødstrup Hospital: lead

Study Sites (1)

University Clinic in Nephrology and Hypertension, Gødstrup Regional Hospital and Aarhus University

Herning, 7400, Denmark

RECRUITING

MeSH Terms

Conditions

Hypertension; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kezia T McWhan, MD

CONTACT

004578436580; kezmcw@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 18, 2025
• Study Start: December 8, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2030
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)