Aldosterone bloCkade for Health Improvement EValuation in End-stage Renal Disease (ACHIEVE)
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|ClinicalTrials.gov Identifier: NCT03020303|
Recruitment Status : Recruiting
First Posted : January 13, 2017
Last Update Posted : October 22, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Endstage Renal Disease||Drug: Spironolactone 25Mg Tablet Drug: Placebo Oral Tablet||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2750 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Aldosterone bloCkade for Health Improvement EValuation in End-stage Renal Disease|
|Actual Study Start Date :||July 7, 2017|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||September 2023|
Placebo Comparator: Placebo Oral Tablet
A tablet with no active medication that will be an exact match of the active spironolactone in taste and appearance
Drug: Placebo Oral Tablet
Randomized participants will receive a study supply of placebo tablets with no active medical ingredients. They will be instructed to take 1 tablet daily.
Active Comparator: Spironolactone 25 MG Tablet
25 mg of active spironolactone in tablet form
Drug: Spironolactone 25Mg Tablet
Randomized participants will receive a study supply of spironolactone 25 mg tablets. They will be instructed to take 1 tablet daily.
- CV Death or Hospitalization for Heart Failure [ Time Frame: up to 5 years ]
- Cause specific death [ Time Frame: up to 5 years ]
- Hospitalization for Heart Failure [ Time Frame: up to 5 years ]
- All-cause death [ Time Frame: up to 5 years ]
- All-cause Hospitalization [ Time Frame: up to 5 years ]
- Hospitalization for hyperkalemia [ Time Frame: up to 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03020303
|Contact: Joanne Wilkinson, B.A.||9055274322 ext firstname.lastname@example.org|
|Contact: Kayla Pohl, B.A.||9055274322 ext email@example.com|
|Principal Investigator:||Michael Walsh, MD, PhD||McMaster University|
|Study Chair:||PJ Devereaux, MD, PhD||McMaster University|