None listed
Conditions
Brief summary
The trial will invite patients at the Alfred Hospital, Melbourne, Victoria presenting with acute decompensated heart failure to participate in a study of a dietary supplement (Beetroot extract - Dietary Nitrate) within 48 hours of their hospital admission. Heart failure is a condition where the heart fails to provide enough blood pumping power for the needs of normal body function. At times the condition may worsen significantly leading to fluid retention, low blood pressure, kidney failure and breathlessness, which usually each requires hospitalization. Currently there are limited treatment options available for these patients and there is a high risk of further hospitalization or death in subsequent months after the patient’s admission to hospital. In this study we propose to study the effects of dietary nitrate in th patients described above. There is a growing body of evidence that dietary nitrate in the form of concentrated beetroot supplementation has beneficial cardiovascular effects including lowering blood pressure and enhances exercise performance during sub-maximal exercise. Forty patients will be invited to participate in the trial. After obtaining informed consent, twenty patients will be randomly assigned to treatment with oral Dietary Nitrate (70ml concentrated beetroot juice, manufactured by James White UK) or nitrate depleted placebo once daily for five days. This is in addition to any other medication prescribed by their treating doctor. At enrolment the patients will be educated and counselled about the trial and the intervention medication. Various parameters will be monitored on a daily basis, including objective and subjective symptom review, observations, blood vessel function, weight, kidney function, and medication requirement. Blood samples will also be taken and stored for analysis. We will contact the patient by telephone after 30 days to ask about their health. The primary objective of the trial is to see whether the administration of dietary nitrate will improve blood vessel function and overall treatment outcomes.
Interventions
The dietary nitrate will be in the form of a commercially available beetroot supplement manufactured from organic beetroot by James White Drinks (UK). It is a 70ml preparation that contains 0.4g of dietary nitrate. The researchers have no financial relationship with James White Drinks.
For this study the investigational product and placebo control will be sourced directly from the manufacturer in the UK.
Study Frequency - 5 days of treatment, once daily for 5 days
Sponsors
Alfred Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Age 18-75 years Acute decompensated HF requiring hospitalization (at the discretion of the treating physician), reflected by clinical signs or symptoms of peripheral or pulmonary congestion NYHAC III or IV And LVEF less than 40% (either previously documented or documented at admission)
Exclusion criteria
Age between 18, and 75 Hypotension (BP less than 90) inotropic therapy anticipated need for LVAD or ECMO within 48 hrs endotracheal intubation/ventilation cardiac or other solid organ transplantation STEMI at presentation suspected sepsis arrhyhthmia as a primary cause for ADHF Allergy to Beetroot Pregnancy
Outcome results
None listed