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New treatment option for Hypertension
Official title The Effects of Dietary Nitrate in Patients With Hypertensive Kidney Injury
ClinicalTrials.gov ID: NCT07290842
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Hypertension, treated with a maximum of 2 antihypertensive drugs and unattended office BP \< 150/95 mmHg at the screening visit, or newly diagnosed...
- 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...
- Albumin/creatinine ratio \< 500 mg/g
- eGFR \> 30 ml/min/1,73m2
- Body Mass Index (BMI) ≤ 35 kg/m2
You likely can't join 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
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Herning, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Herning, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.