Clinical Trials Logo
  1. Home
  2. Endstage Renal Disease
  3. NCT03020303

Aldosterone bloCkade for Health Improvement EValuation in End-stage Renal Disease — ACHIEVE  

Endstage Renal Disease Clinical Trial

Official title:
Aldosterone bloCkade for Health Improvement EValuation in End-stage Renal Disease

Clinical Trial Summary

Individuals receiving dialysis are at risk of heart failure and heart related death. There is an urgent need for treatments that reduce the risk of these problems in patients that require dialysis. Spironolactone is a pill used to prevent heart failure and related deaths in patients that do not require dialysis. It works by blocking a hormone (aldosterone) in your body that causes high blood pressure and can damage the heart. Although spironolactone is very effective in patients that do not require dialysis, we do not know if spironolactone is effective in dialysis patients. Our research will help determine if spironolactone reduces heart failure and heart related deaths in dialysis patients. The purpose of this study is to determine if spironolactone reduces death or hospitalization for heart failure and is well tolerated in patients that require dialysis.

Clinical Trial Description

Globally, over 2 million people receive dialysis for end-stage renal disease (ESRD) and 650,000 new patients start dialysis each year. Furthermore, the number of patients receiving dialysis is increasing as access to dialysis in the developing world improves and the prevalence of diabetes and vascular disease rises. Despite technical advances in dialysis, the outcomes for patients with ESRD are poor. Patients have frequent hospitalizations, poor health related quality of life and strikingly, high mortality rates. The most common cause of death in patients receiving dialysis is cardiovascular disease, accounting for >40% of all deaths. Observational studies suggest a causal pathway to cardiovascular death that includes progressive ventricular hypertrophy and dilatation as well as accelerated atherosclerosis. These changes result in myocardial ischemia and cardiac fibrosis that, in turn, lead to heart failure, arrhythmias and cardiac arrest. Strongly implicated in this pathophysiology is aldosterone. Mineralocorticoid receptor antagonists (MRAs) in non-ESRD patients, prevent cardiovascular deaths and small randomized controlled trials of MRAs in ESRD suggests they may reduce death and may be safe. Spironolactone is the most commonly used MRA worldwide. We will conduct a multicentre randomized controlled trial (RCT) to determine if spironolactone reduces cardiac mortality and hospitalizations for heart failure in patients treated with dialysis. This trial is called the Aldosterone bloCkade for Health Improvement EValuation in End-stage renal disease (ACHIEVE). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03020303
Study type Interventional
Source Population Health Research Institute
Contact Jessica Tyrwhitt, B.A.
Phone 9055274322
Email jessica.tyrwhitt@phri.ca
Status Recruiting
Phase Phase 3
Start date July 7, 2017
Completion date January 2025
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03023748 - Intravenous Paricalcitol in Chronic Hemodialysis Patients Phase 4
Completed NCT00745914 - Peroxisome Proliferator-Activated Receptor-gamma (PPAR-gamma) Agonist in Diabetic End-Stage Renal Disease Patients N/A
Terminated NCT00776191 - Randomized Multicenter Cross-over Study to Compare the Effect of Physioneal 35 to 40 on the Protein Metabolism Phase 4
Completed NCT02981706 - Comparison of AVF Versus AVG in Elderly Patients Starting Dialysis N/A
Completed NCT02946229 - Data Collection for Next Generation Ultrasound Technology Development N/A
Completed NCT02966028 - Effect of SNF472 on Progression of Cardiovascular Calcification in End-Stage-Renal-Disease (ESRD) Patients on Hemodialysis (HD) Phase 2
Completed NCT02976246 - Effect of Vitamin K2 (MK7) on Cardiovascular and Bone Disease in Dialysis Patients Phase 4
Recruiting NCT02957877 - LMWH Infusion as Anticoagulation for Home HD Phase 4
Completed NCT00745719 - Parathyroidectomy in Endstage Renal Disease N/A
Completed NCT03010072 - The Effect of Phosphate Lowering Using Sucroferric Oxyhydroxide (PA21) on Calcification Propensity of Serum Phase 2
Completed NCT00745589 - Sevelamer Hydrochloride in Peritoneal Dialysis Patients N/A
Not yet recruiting NCT02976688 - Effects of Short-chain Fatty Acids on Inflammatory and Metabolic Parameters in Maintenance Hemodialysis Phase 2/Phase 3
Completed NCT02970201 - Improving Adherence in Renal Dialysis Patients Through Electronic Interventions N/A
Withdrawn NCT00502268 - Vitamin D and Carboxy PTH Fragments in Coronary Calcification Phase 4
Completed NCT02207153 - Risk Assessment by Cardiovascular Biomarkers in Chronic Dialysis Patients
Completed NCT02977117 - The Effect of Increasing Dialysate Magnesium on Calcification Propensity in Subjects on Haemodialysis Phase 2
Completed NCT02866214 - Effect of Febuxostat on Endothelial Dysfunction in Hemodialysis Patients. Phase 2/Phase 3
Not yet recruiting NCT03054454 - A Podiatry Led MDT Intervention to Reduce the Burden of Foot Disease in Patients With End Stage Kidney Failure N/A