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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
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The study is a single center randomised, double-blind, placebo-controlled crossover study to assess the effects of beetroot juice in patients with pulmonary arterial hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitrate rich beetroot juice | Active Comparator | Eligible subjects will be randomised, in a double-blind crossover design, to receive treatment with either nitrate rich beetroot juice (70 ml containing approximately 8 mmol nitrate - active comparator) or nitrate depleted beetroot juice (70 ml - placebo) twice daily for 7 days (treatment period 1) followed by a 7 day washout period followed by treatment twice daily with the active comparator or placebo depending on initial treatment for another 7 days (treatment period 2) . |
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| Nitrate depleted beetroot juice | Placebo Comparator | Eligible subjects will be randomised, in a double-blind crossover design, to receive treatment with either nitrate rich beetroot juice (70 ml containing approximately 8 mmol nitrate - active comparator) or nitrate depleted beetroot juice (70 ml - placebo)twice daily for 7 days (treatment period 1) followed by a 7 day washout period followed by treatment twice daily with the active comparator or placebo depending on initial treatment for another 7 days (treatment period 2) . |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beetroot juice | Dietary Supplement |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in VO2 submax and or VO2 max | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 6MWT | 7 days | |
| Change in WHO functional class | 7 days | |
| Change in echocardiographic parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerhard Wikström, MD, PhD | Uppsala University and Uppsala University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uppsala University Hospital | Uppsala | Sweden |
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| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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Change in; pulmonary artery systolic pressure (PASP), ventricular diastolic function, systolic right and left ventricular function, right and left atrial/ventricular dimensions will be calculated |
| 7 days |
| Change in exhaled NO | 7 days |
| Change in systemic bloodpressure | 7 days |
| Change in metabolic pathways involved in nitric oxide production and regulation | Change in the following biochemical variables will be calculated; ADMA, SDMA, Arginine, Citrulline, Ornithine, uric acid, nitrate, nitrite | 7 days |
| Change in NT-pro-BNP | 7 days |