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| ID | Type | Description | Link |
|---|---|---|---|
| 1-10-72-253-17 | Other Identifier | The Scientific Ethical Committees for Central Denmark Region |
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A reduction of dietary sodium intake reduces blood pressure and risk of cardiovascular disease.
A reduction of dietary sodium intake reduces blood pressure and risk of cardiovascular disease. Patients with hypertension resistant of antihypertensive treatment have a high frequency of non-dipping and obstructive sleep apnoea (OSA). The aim of this project is to analyse the effect of dietary sodium restriction on nocturnal blood pressure and nocturnal pauses in breathing in this patients population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary sodium restriction | Experimental | DIetary sodium restriction |
|
| Usual diet | No Intervention | Usual diet |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary sodium restriction | Behavioral | Selfemployed dietary sodium restriction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in nocturnal systolic blood pressure | Comparison of blood pressure measured by 24 hour blood pressure measurements at baseline conditions (after two weeks of usual diet) and intervention (after two weeks of dietary sodium restriction) | from day 14 to day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in day (systolic and diastolic) and 24h blood pressure (systolic and diastolic) | Comparison of blood pressure measured by 24h blood pressure measurements at baseline conditions (after two weeks of usual diet) and intervention (after two weeks of dietary sodium restriction) | from day 14 to day 28 |
| Changes in number of nocturnal pauses in breathing (apnoea hypopnoea index, AHI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bodil Hornstrup | M.D., Ph.D. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University clinic in Nephrology and hypertension, Regional Hospital Godstrup | Gødstrup | Herning | 7400 | Denmark | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37726656 | Derived | Hornstrup BG, Hoffmann-Petersen N, Lauridsen TG, Bech JN. Dietary sodium restriction reduces blood pressure in patients with treatment resistant hypertension. BMC Nephrol. 2023 Sep 19;24(1):274. doi: 10.1186/s12882-023-03333-9. |
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Not blinded cross over trial. First arm is usual diet for two weeks, second arm is sodium dietary restriction.
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Binding not possible as patients needs to carry out dietary sodium restriction themselves.
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Comparison of apnoea hypopnoea index measured by cardio respiratory monitoring at baseline conditions (after two weeks of usual diet) and intervention (after two weeks of dietary sodium restriction) |
| from day 14 to day 28 |
| Changes in day:night sodium urinary sodium excretion | Comparison of baseline conditions (after two weeks of usual diet) and intervention (after two weeks of dietary sodium restriction) | from day 14 to day 28 |
| Changes in urinary excretion of aquaporin-2 (U-AQP2) og epithelial sodium channel (u-ENaCÉ£) | Comparison of baseline conditions (after two weeks of usual diet) and intervention (after two weeks of dietary sodium restriction) | from day 14 to day 28 |
| Changes in endothelial function (nitric oxide (NO), erythrocyte sodium sensitivity) | Comparison of biomarkers from blood samples drawn at baseline conditions (after two weeks of usual diet) and intervention (after two weeks of dietary sodium restriction) | from day 14 to day 28 |
| Department of Medical Research and Medicine, Holstebro Regional Hospital |
| Holstebro |
| 7500 |
| Denmark |