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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
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Population Health Research Institute

Brief 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.


Condition or disease Intervention/treatment Phase
Endstage Renal Disease Drug: Spironolactone 25Mg Tablet Drug: Placebo Oral Tablet Phase 3

Detailed 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. CV Death or Hospitalization for Heart Failure [ Time Frame: up to 5 years ]

Secondary Outcome Measures :
  1. Cause specific death [ Time Frame: up to 5 years ]
  2. Hospitalization for Heart Failure [ Time Frame: up to 5 years ]
  3. All-cause death [ Time Frame: up to 5 years ]
  4. All-cause Hospitalization [ Time Frame: up to 5 years ]
  5. Hospitalization for hyperkalemia [ Time Frame: up to 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age

    1. ≥45 years or
    2. ≥18 with a history of diabetes
  2. On dialysis ≥ 90 days
  3. On either

    1. Hemodialysis prescribed at least 2 treatments per week or
    2. Peritoneal dialysis prescribed with at least 1 exchange daily
  4. Provides informed consent

Exclusion Criteria:

  1. Hyperkalemia

    1. Serum potassium >5.8 mmol/L in the 6 weeks prior to enrollment or
    2. Serum potassium >6.0 mmol/L during active run-in
  2. Currently taking and unable to withdraw a mineralocorticoid receptor antagonist (i.e. spironolactone or eplerenone).
  3. Known sensitivity or allergy to spironolactone
  4. Current or planned pregnancy or breastfeeding
  5. Scheduled living related donor renal transplant
  6. Life expectancy < 6 months in the opinion of a treating nephrologist.
  7. Enrolled in another interventional trial testing a mineralocorticoid receptor antagonist or drug that has a known or likely interaction with spironolactone.
  8. Treating physician believes either spironolactone is either absolutely indicated or absolutely contra-indicated

Information from the National Library of Medicine

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


Contacts
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Contact: Joanne Wilkinson, B.A. 9055274322 ext 40357 joanne.wilkinson@phri.ca
Contact: Kayla Pohl, B.A. 9055274322 ext 40694 kayla.pohl@phri.ca

Locations
Show Show 85 study locations
Sponsors and Collaborators
Population Health Research Institute
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Michael Walsh, MD, PhD McMaster University
Study Chair: PJ Devereaux, MD, PhD McMaster University
Publications:
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Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT03020303    
Other Study ID Numbers: ACHIEVE
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: N/A - no plan to make IPD available to other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents