The Intravenous Amino Acid Therapy for Vascular Rigidity in End Stage Renal Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorHaukeland University Hospital
About this trial
The goal of this study is to learn if giving amino acids through the dialysis machine can help protect the blood vessels and heart in people with kidney failure. Patients on dialysis often have problems with stiff blood vessels, which increases their risk of heart attacks, strokes, and other cardiovascular diseases. A chemical change called carbamylation is thought to make blood vessels age and stiffen faster. Amino acids may block this process and improve blood vessel health.
The main questions are:
* Does amino acid treatment reduce the risk of death in dialysis patients? * Does it improve the health of the heart and blood vessels? * What side effects or medical problems happen when patients receive amino acids during dialysis?
In this study:
* Participants will be randomly assigned to receive either amino acids (Synthamin 9®) or a placebo (saline). * The infusion (250 ml) will be given twice a week during dialysis sessions for 12 months. * After 12 months of treatment, patients will be followed for another 6 months.
During the study, patients will:
* Have regular blood tests to measure markers of blood vessel health, inflammation, and protein carbamylation. * Undergo heart and vessel tests, including echocardiography, CT scans, and pulse wave velocity measurements. * Complete quality-of-life questionnaires about symptoms and daily living.
By comparing the amino acid group with the placebo group, researchers will see whether amino acid therapy can make dialysis patients live longer and have healthier hearts and blood vessels.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
Diagnosis of end-stage renal disease (ESRD) and undergoing maintenance hemodialysis (HD) or online hemodiafiltration (HDF).
On a stable dialysis regimen for a minimum of 90 consecutive days prior to enrollment.
Serum albumin level ≥30 g/L.
Disqualifiers
Administration of parenteral amino acids or intravenous nutrition within the past 90 days.
Severe hypertension (e.g., SBP >180 mmHg despite antihypertensive therapy).
Advanced liver disease classified as Child-Pugh class C.
Diagnosis of active malignancy or cancer treatment within the last 5 years.
Trial design
Design model
Parallel
Treatments tested in this trial
Amino Acid Supplementation
Dietary supplement* Product: Synthamin 9® (Baxter), a sterile, pyrogen-free solution of amino acids for injection (5.5%). * Dose: 250 ml per administration, providing approximately 13.7 g of free amino acids. * Administration: Intravenously during the first hour of hemodialysis. * Frequency: Twice weekly (preferably on the two longest HD sessions) for 12 months.
Sterile Saline Arm
Other interventionProduct: Isotonic saline solution (0.9% NaCl), 250 ml. • Administration and frequency: Identical to the intervention arm.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Amino Acid SupplementationExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
All-cause mortality over a 12-month period.
This outcome is selected due to the low sample size in each group and the expectation that there may not be many hard cardiovascular events within the 1-year follow-up. The use of all-cause mortality provides a robust endpoint that captures overall patient survival. data will be analyzed with Cox proportional hazard regression, Kaplan -Mayer survival curves and log rank test.
Time frame
12 month from enrollmentSecondary outcomes
1
CVD
Composite endpoints (MACCE), including heart failure-related hospitalizations, stroke, myocardial infarction, PCI/CABG, and peripheral vascular events. These composite endpoints are designed to assess the broader impact of amino acid therapy on major adverse cardiovascular and cerebrovascular events, providing a comprehensive overview of its effects on cardiovascular outcomes.
Time frame
12 months from enrollment2
CVD 2 - PWV
Change in vascular stiffness over a 12-month period, assessed by pulse wave velocity (PWV). The measure of PWV (cartoid to femoral artery) will be measured and compared to reference valus for patients age and sex. These measures will provide a direct assessment of arterial stiffness and vascular compliance, critical indicators of cardiovascular health in ESRD patients
Time frame
12 months from enrollment3
CVD - Alx
Change in vascular stiffness over a 12-month period will be assessed by augmentation index (AIx) to provide a direct assessment of arterial stiffness and vascular compliance, critical indicators of cardiovascular health in ESRD patients. The score will be calculated by dividing the augmentation pressure by pulse pressure multiplied by 100.
Time frame
12 months from enrollment4
CVD 3 - CAC
Coronary artery calcification (CAC) will be evaluated by the Agatston score, assessed via non-contrast heart CT scans at baseline and the end of the 12-month period. The radiologist will identify areas of calcium in the coronary arteries, multiply the area by a density weighting factor based on Hounsfield density measurements. The score will be presented as 0- low risk; 1-99- Mildly increased risk; 100-299 Moderatly increased risk and 300+ and severly increased risk. This will enable us to evaluate the impact of amino acid therapy on the progression of calcification and atherosclerosis, a major risk factor for CV events in CKD patients
Time frame
12 months from enrollmentSponsors and contacts
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Source ClinicalTrials.gov
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