Pulmonary Arterial Hypertension
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTBeetroot juice
Sponsors
Karolinska Institutet
Uppsala University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* PAH (pulmonary arterial hypertension) * WHO functional class II-III
Exclusion criteria
* WHO functional class I or IV * pregnancy * known intolerance or allergy to beetroot * treatment with Allopurinol * treatment with Iloprost (inhaled) * systolic bloodpressure \< 95 mmHg * diabetes mellitus type 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in VO2 submax and or VO2 max | 7 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in WHO functional class | 7 days | — |
| Change in echocardiographic parameters | 7 days | 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 |
| Change in exhaled NO | 7 days | — |
| Change in 6MWT | 7 days | — |
| Change in metabolic pathways involved in nitric oxide production and regulation | 7 days | Change in the following biochemical variables will be calculated; ADMA, SDMA, Arginine, Citrulline, Ornithine, uric acid, nitrate, nitrite |
| Change in NT-pro-BNP | 7 days | — |
| Change in systemic bloodpressure | 7 days | — |
Countries
Sweden
Outcome results
None listed