Suplementación Con Zumo de REmolacha Para Prevenir la Nefropatía Asociada a Contraste Durante la hospitalización Por Síndrome Coronario Agudo Sin elevación Del ST
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Number of Participants with Contrast-induced nephropathy
Study Overview
Brief Summary
The goal of this study is to compare the possible beneficial effect of beetroot juice supplementation versus the usual management during hospitalization to prevent contrast-induced nephropathy after cardiac catheterizations.
The study includes patients diagnosed with non-ST elevation acute coronary syndrome with a possible indication for catheterism and high risk of kidney injury related to iodinated contrast.
The intervention group will drink 500 mL (2 glasses daily, at breakfast and dinner) of beetroot juice added to the usual diet for 7 days or until hospital discharge and will receive the recommendation to maintain a diet rich in inorganic nitrates. The control group will receive the usual diet and recommendations. In both cases, other therapies will be prescribed to prevent contrast-induced nephropathy (hydration and statins) if there is no contraindication.
Our hypothesis is that a compound present in beetroot juice, inorganic nitrates, can prevent the deterioration of kidney function related to contrast due to its vasodilatory effect, in addition to improving the subsequent prognosis of coronary heart disease due to its anti-inflammatory and antiproliferative effects, protector of the endothelium and inhibitor of platelet aggregation. Beetroot juice could also be beneficial in this context due to the antioxidant effect of the betalains it contains.
Detailed Description
Contrast-induced nephropathy (CIN) is a common complication in patients admitted for acute coronary syndrome (ACS) who undergo percutaneous coronary intervention (PCI).
Although the deterioration of renal function is generally reversible, avoiding CIN is of great importance as it is associated with worse prognosis, including greater need for renal replacement therapies and greater mortality.
Inorganic nitrates (NO3-) are the most promising therapy to prevent CIN, due to their ability to be metabolized to nitric oxide (NO), whose vasodilator effect protects renal perfusion. In addition, NO has other potential benefits in ACS due to its anti-inflammatory, antiproliferative, endothelium protective, and platelet aggregation inhibitor effects.
The recent NITRATE-CIN study has shown that the administration of 12 mmol/24 h of KNO3 for 5 days to patients admitted for non-ST elevation (NSTE) ACS undergoing PCI not only significantly reduced the risk of CIN, but also prevented the deterioration of kidney function and significantly reduced major cardiovascular complications (MACE) during follow-up.
However, there is currently no comercially available presentation for KNO3 and its administration could be associated with hyperkalemia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of Acute Coronary Syndrome without persistent ST segment elevation, with recommendation for invasive management according to the actual Clinical practice guidelines
- •At least moderate or high risk of nephropathy associated with iodinated contrast (Mehran score (without including contrast volume) ≥ 6).
Exclusion Criteria
- •<18 years old or without capacity to give consent.
- •Refusal to participate in the study.
- •Known hypersensitivity to beetroot or any of its allergens.
- •Pregnant.
- •Inability to take food orally
- •Serious illnesses (not related to ACS or kidney failure), which limits their life expectancy to a period predictably less than 1 year.
- •On dialysis or predialysis at the time of inclusion.
- •ACS with persistent ST segment elevation before inclusion.
- •Shock or inotrope dependence at the time of inclusion
- •PCI already performed before inclusion.
- •Patients receiving intravenous nitroglycerin for > 1 hour before inclusion
Arms & Interventions
Beetroot juice supplementation
Supplementation with 500 mL of beetroot juice daily in 2 doses of 250 mL, for 7 days, or until hospital discharge, and a recommendation to maintain a diet rich in vegetables with high nitrate content after discharge.
(In addition to usual treatment with hydration and statins to prevent contrast induced nephropathy)
Intervention: Beetroot juice (Dietary Supplement)
Usual care
Usual treatment with hydration and statins to prevent contrast induced nephropathy
Outcomes
Primary Outcomes
Number of Participants with Contrast-induced nephropathy
Time Frame: 7 days
Defined as an increase in serum creatinine ≥0.3 mg/dL in the first 48 hours or ≥1.5 times the baseline value during the week after the first PCI performed on admission
Secondary Outcomes
- Number of Participants with In-hospital MACE (Major adverse cardiovascular events)(Up to 30 days)
- Number of Participants with In-hospital hyperkalemia(Up to 30 days)
- Rate of Drop-out from beetroot juice during hospitalization(7 days)
- Relative and absolute changes from baseline of serum creatinine and estimated glomerular filtration rate during follow-up(1 year)
- Number of Participants with Need for renal replacement therapy(1 year)
- Number of Participants with MACE during follow-up(1 year)
Investigators
Jose Manuel Andreu Cayuelas
Principal Investigator
Hospital General Universitario Santa Lucia