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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.
AIM: We aim to investigate the mechanisms behind the cardiovascular and renal effect of nitrates in patients with hypertension and hypertensive kidney injury.
HYPOTHESIS: Dietary nitrate decreases BP and increases renal blood flow. This is independent of renal function or enhanced during low eGFR due to reduced renal clearance of nitrate.
METHODS: 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 each treatment period effect variables will be measured, including include 24 hour bloodpressure measurment. Technetium(Tc)99m - Diethylenetriamine pentaacetate (DTPA) clearance and water based positron emission tomography computed tomography (PET/CT) is performed only after the intervention periods.
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.
PERSPECTIVE: The knowledge gained from these studies can lead to improved dietary counselling, which is a promising approach in the treatment of hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beetroot juice (active) | Active Comparator | nitrate content: 400 mg |
|
| Beetroot juice (placebo) | Placebo Comparator | nitrate free |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Diastolic blood pressure | Mobil graph with 24 h measurments | Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period) |
| Heart rate |
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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.
Exclusion Criteria:
• Diagnosis of heart failure, NYHA II-IV
Organic nitrate treatment Diagnosed secondary hypertension other than renal parenchymal hypertension (i.e. renal artery stenosis, primary hyperaldosteronism, low renin hypertension etc.)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kezia T McWhan, MD | Contact | 004578436580 | kezmcw@rm.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinic in Nephrology and Hypertension, Gødstrup Regional Hospital and Aarhus University | Recruiting | Herning | 7400 | Denmark |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
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|
| 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. |
|
Mobil graph with 24 h measurment
| Measured on 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period) |
| Pulsewave velocity | Mobil graph with 24 h measurment | Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period) |
| Augmentation index | Mobilograph with 24 h measurment | Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period) |
| Vascular resistance | Mobilograph 24 hour measurments | Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period) |
| Reflection index | Mobilograph 24 hour measuments | Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period) |
| Dipping status | Mobilograph 24 hour measurments | Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period) |
| Blood pressure variability | Mobil graph with 24 h measurment | Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period) |
| Unattended office blood pressure | Measured on the examination days after 5 minutes rest 3 times by an autoumated ossilometric device in an undisturbed room. The mean of the tre measurments is used. | Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period) |
| Renal Blood Flow (RBF) | Change in RBF determined by water based PET/CT scans | Measured on Day 15 of each intervention period |
| GFR | Change in GFR measured by Tc99m-DTPA clearance | Measured on Day 15 of each intervention period |
| Urine concentration of renal tubular transport proteins | Urine excretions of aquaporin 2 (AQP2), thiazide-sensitive sodium-chloride cotransporter (NCC) and distal epithelial sodium channel (ENaC) | Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period) |
| Vasoactive hormones | Change in plasma levels of aldosterone, renin, brain natriuretic peptide (BNP), atrial natriuretic peptide (ANP), copeptin | Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period) |
| Measurements of the NO-system | Blood and urine levels of: Nitrite, nitrate, cyclic guanosine monophosphate (cGMP) | Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period) |
| Plasma and urine levels of sodium, potassium, creatinine, urea, uric acid, albumin and osmolality | Measured in blood and urine (24 h collection). Abbsolute and fractional excretions of sodium and potassium and free water clearence will be calculated. | Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period) |
| Body composition measurments from bioimpedance spectroscopy | Fresenius Body composition monitor is used, which estimates the compartments in the bodycomposition: Extracellular Body Water (L), Total Body Water (L), Intracellular Body Water (L), Overhydration (L) | Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period) |
| Body weight | Patient weight (kg) | Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of the intervention period) |
| Central Blood pressure | Sphygmocor measurments | Measured on 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period) |
| Microvascular function | Laser speckle contrast imaging | Measured on 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period) |
| D014570 |
| Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |