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Aldosterone BloCkade for Health Improvement EValuation in End-stage Renal Disease

PHASE3RECRUITING

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.

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Study details:

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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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Age: ≥45 years or ≥18 with a history of diabetes

On dialysis ≥ 90 days

On either: Hemodialysis prescribed at least 2 treatments per week or Peritoneal dialysis prescribed with at least 1 exchange daily

Provides informed consent

Exclusion criteria

Hyperkalemia: Serum potassium >5.8 mmol/L in the 6 weeks prior to enrollment or Serum potassium >6.0 mmol/L during active run-in

Currently taking and unable to withdraw a mineralocorticoid receptor antagonist (i.e. spironolactone or eplerenone)

Known sensitivity or allergy to spironolactone

Current or planned pregnancy or breastfeeding

Scheduled living related donor renal transplant

Life expectancy < 6 months in the opinion of a treating nephrologist

Enrolled in another interventional trial testing a mineralocorticoid receptor antagonist or drug that has a known or likely interaction with spironolactone

Treating physician believes either spironolactone is either absolutely indicated or absolutely contra-indicated

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2017-07-07

Primary completion: 2025-07-01

Study completion finish: 2026-04-01

Study type

PREVENTION

Phase

PHASE3

Trial ID

NCT03020303

Intervention or treatment

DRUG: Spironolactone 25Mg Tablet

DRUG: Placebo Oral Tablet

Conditions

• Endstage Renal Disease

Condition: Endstage Renal Disease
DRUG: Spironolactone 25Mg Tablet and other drugs
Garran, Australian Capital Territory, Australia and more
Sponsor: Population Health Research Institute

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Canberra Hospital

Research sites nearby

Select from list below to view details:

Canberra Hospital
Garran, Australian Capital Territory, Australia
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Northern Beaches Hospital
Frenchs Forest, New South Wales, Australia
Sydney Adventist Hospital
Wahroonga, New South Wales, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/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.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
CV Death or Hospitalization for Heart Failure	Not Specified	up to 5 years

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Cause specific death	Not Specified	up to 5 years
Hospitalization for Heart Failure	Not Specified	up to 5 years
All-cause death	Not Specified	up to 5 years
All-cause Hospitalization	Not Specified	up to 5 years
Hospitalization for hyperkalemia	Not Specified	up to 5 years

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: Aldosterone BloCkade for Health Improvement EValuation in End-stage Renal Disease