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

March 17, 2025 updated by: Population Health Research Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

2538

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • Canberra Hospital
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Concord Repatriation General Hospital
      • Frenchs Forest, New South Wales, Australia, 2086
        • Northern Beaches Hospital
      • Wahroonga, New South Wales, Australia, 2076
        • Sydney Adventist Hospital
      • Wahroonga, New South Wales, Australia, 2076
        • Royal North Shore Hospital
    • Queensland
      • Birtinya, Queensland, Australia, 4575
        • Sunshine Coast University Hospital
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane Women's Hospital
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Health
      • Saint Albans, Victoria, Australia, 3021
        • Western Health - Sunshine Hospital
  • Brazil
      • Bela Vista, Brazil
        • Hospital Alemao Oswaldo Cruz
      • Ponta Grossa, Brazil
        • Santa Casa de Misericórdia de Ponta Grossa
    • Belo Horizonte
      • Santa Efigênia, Belo Horizonte, Brazil, 30150221
        • Santa Casa de Misericordia de Belo Horizonte
    • Botucatu
      • Rubiao Junior, Botucatu, Brazil, 18618-687
        • Medical School of Botucatu of the Paulista State University - UNESP
    • Joinville
      • Boa Vista, Joinville, Brazil, 89227680
        • Fundacao Pro-Rim
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30110934
        • Felicio Rocho Foundation - Hospital Felicio Rocho
      • Belo Horizonte, Minas Gerais, Brazil, 31110580
        • Fundação Hospitalar São Francisco de Assis
      • Uba, Minas Gerais, Brazil, 36500008
        • Servico Ubaense de Nefrologia Ltda
    • Parana
      • Campina Grande Do Sul, Parana, Brazil, 83430000
        • Sociedade Hospitalar Angelina Caron
      • Curitiba, Parana, Brazil, 80440-020
        • Instituto Pro Renal Brazil
    • Porto Alegre
      • Bairro Santa Teresa, Porto Alegre, Brazil, 90020090
        • Irmandade da Santa Casa de Misericordia de Porto Alegre -ISCMPA
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Hospital de Clínicas de Porto Alegre
    • Santa Catarina
      • Brusque, Santa Catarina, Brazil, 8835404
        • Hospital Arquidiocesano Consul Carlos Reneaux
    • Sao Paulo
      • Santo André, Sao Paulo, Brazil, 09090 790
        • Praxis Pesquisa Medica S/S
      • Votuporanga, Sao Paulo, Brazil, 15500003
        • Santa Casa de Misericórdia de Votuporanga
    • South Carolina
      • Blumenau, South Carolina, Brazil, 89010500
        • PROCARDIO Clinica Cardiologica
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Foothills Hospital
      • Edmonton, Alberta, Canada, T6G 2G3
        • University of Alberta
    • British Colombia
      • Kamloops, British Colombia, Canada, V2C 2T1
        • Royal Inland Hospital
      • Kelowna, British Colombia, Canada, V1Y 1T2
        • Kelowna General Hospital
      • Vancouver, British Colombia, Canada, V6Z 1Y6
        • St. Pauls Hospital
    • British Columbia
      • Penticton, British Columbia, Canada
        • Penticton Regional Hospital
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Queen Elizabeth II Health Science Centre
      • Sydney, Nova Scotia, Canada
        • Cape Breton Regional Hospital
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Healthcare
      • Kingston, Ontario, Canada
        • Queens University at Kingston General Hospital, Division of Nephrology
      • London, Ontario, Canada, N6A 5W9
        • Victoria Hospital
      • Ottawa, Ontario, Canada, K1Y 4E9
        • Ottawa Hospital Research Institute
      • Sudbury, Ontario, Canada, P3E 5J1
        • Health Sciences North Research Institute
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
      • Toronto, Ontario, Canada, M6R 1B5
        • St. Josephs, Toronto
      • Toronto, Ontario, Canada
        • Humber River Health
    • Quebec
      • Montreal, Quebec, Canada, H4J 1C5
        • Hopital Du Sacre-Coeur de Montreal
      • Montreal, Quebec, Canada, H1T 2M4
        • CIUSSS Hopital Maisonneuve- Rosemont
      • Montreal, Quebec, Canada
        • The Sir Mortimer B. Davis Jewish General Hospital
      • Montréal, Quebec, Canada, H2W 1T8
        • Centre Hospitalier de l'Universite de Montreal (CHUM)
      • Québec, Quebec, Canada, G1R 2J6
        • CHU de Quebec L'Hotel-Dieu de Quebec
  • China
      • Baotou, China
        • The First Affiliated Hospital of Baotou Medical College
      • Beijing, China
        • Beijing Tongren Hospital, Capital Medical University
      • Beijing, China
        • Emergency General Hospital
      • Beijing, China
        • Beijing Miyun District Hospital
      • Changchun, China
        • Faw General Hospital of Jilin Province
      • Enshi, China
        • The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture
      • Huai'an, China
        • Huai'an First Peoples Hospital
      • Kunming, China
        • The First Hospital of Kunming
      • Lanzhou, China
        • Gansu Baoshihua Hospital
      • Luoyang, China
        • Yichuan County Traditional Chinese Medicine Hospital
      • Shanghai, China
        • Shanghai Tongji Hospital
      • Shanxi, China
        • Shanxi Provincial Peoples Hospital
      • Suqian, China
        • Shuyang County Hospital of Traditional Chinese Medicine
      • Suqian, China
        • Sihong County Fenjinting Hospital
      • Tianjin, China
        • Tianjin Third Central Hospital
      • Tianjin, China
        • Tianjin Fifth Central Hospital
      • Tongliao, China
        • Tongiao City Hospital
      • Xinxiang, China
        • Xinxiang First Peoples Hospital
      • Xuzhou, China
        • General Hospital of Xuzhou Mining Group
      • Yuxi, China
        • Peoples Hospital of Yuxi City
      • Zhongwei, China
        • Peoples Hospital of Zhongwei
    • Beijing
      • Beijing, Beijing, China
        • Peking University First Hospital
      • Beijing, Beijing, China
        • Peking University Peoples Hospital
    • Ningxia
      • Yinchuan, Ningxia, China
        • General Hospital of Ningxia Medical University
  • Ecuador
    • Pichincha
      • Quito, Pichincha, Ecuador, 170303
        • Clinefnorte CIA Ltda
      • Quito, Pichincha, Ecuador, 170601
        • Nefromedic SA
  • India
      • Madurai, India
        • Government Rajaji Hospital, Madurai
      • Mangalore, India
        • Father Muller Medical College
      • Nagpur, India
        • Seven Star Hospital
    • Chennai
      • Park Town, Chennai, India, 600003
        • Madras Medical College Chennai
    • Karnataka
      • Bangalore, Karnataka, India, 560099
        • Narayana Hrudayalaya Limited
      • Bengaluru, Karnataka, India, 560076
        • Fortis Hospitals
      • Mangaluru, Karnataka, India, 575018
        • K S Hegde Medical Academy
      • Shimoga, Karnataka, India, 577201
        • Nanjappa Hospitals Shimoga
    • Kerala
      • Cochin, Kerala, India, 682027
        • AsterMedCity
      • Kottayam, Kerala, India, 686630
        • Caritas Hospital
    • Maharashtra
      • Dombivli, Maharashtra, India, 421203
        • AIMS Hospital Mumbai
      • Mumbai, Maharashtra, India, 400016
        • National Health and Education Society
      • Mumbai, Maharashtra, India, 421004
        • Ashirwad Hospital Mumbai
      • Nashik, Maharashtra, India, 422002
        • Dhadiwal Hospital
      • Pune, Maharashtra, India, 411004
        • ACE Hospital Une
      • Pune, Maharashtra, India, 411033
        • Aditya Birla Hospital
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600026
        • Vijaya Hospital
      • Chennai, Tamil Nadu, India, 600081
        • Apollo Hospitals
    • Telangana
      • Hyderabad, Telangana, India, 500082
        • Nizams Institute of Medical Sciences
    • Telegana
      • Hyderabad, Telegana, India, 500012
        • Osmania General Hospital
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre (UMMC)
      • Kuala Lumpur, Malaysia, 42896
        • Hospital Kuala Lumpur
      • Kuala Terengganu, Malaysia, 33158
        • Hospital Sultanah Nur Zahirah Kuala Terengganu
      • Kuantan, Malaysia, 29142
        • Hospital Tengku Ampuan Afzan, Kuantan
      • Seremban, Malaysia, 25167
        • Hospital Tuanku Jaafar, Seremban
      • Setapak, Malaysia, 53200
        • Hospital Ampang
    • Johor
      • Johor Bahru, Johor, Malaysia, 80100
        • Hospital Sultanah Aminah, Johor Bahru
      • Muar, Johor, Malaysia
        • Hospital Pakar Sultanah Fatimah
    • Perak
      • Taiping, Perak, Malaysia, 34000
        • Hospital Taiping
    • Pulau Pinang
      • George Town, Pulau Pinang, Malaysia, 10990
        • Hospital Pulau Pinang
    • Selangor
      • Kajang, Selangor, Malaysia, 43000
        • Hospital Kajang
      • Klang, Selangor, Malaysia, 41200
        • Hospital Tengku Ampuan Rahimah Klang
  • New Zealand
      • Dunedin, New Zealand, 9016
        • Dunedin Hospital
      • Hastings, New Zealand, 4120
        • Hawkes Bay Hospital
      • Palmerston North, New Zealand, 4442
        • Palmerston North Hospital
      • Whangarei, New Zealand, 0148
        • Whangarei Hospital
    • Auckland
      • Takapuna, Auckland, New Zealand, 0620
        • North Shore Hospital
    • Waikato
      • Hamilton, Waikato, New Zealand, 3204
        • Waikato Hospital
  • Philippines
    • Manila
      • Ermita, Manila, Philippines, 1000
        • Philippines General Hospital
      • Quezon City, Manila, Philippines, 1101
        • National Kidney and Transplant Institute
  • Turkey
      • Ankara, Turkey
        • Hacettepe University Hospitals Hemodialysis Center
      • Eskişehir, Turkey
        • Osmangazi University
      • Istanbul, Turkey
        • Memorial Service Hospital
  • United Kingdom
      • Aberdeen, United Kingdom, AB23 2ZN
        • Aberdeen Royal Infirmary
      • Belfast, United Kingdom, BT9 7AB
        • Belfast City Hospital
      • Birmingham, United Kingdom
        • Birmingham Hospitals
      • Bristol, United Kingdom, BS10 5NB
        • Southmead Hospital
      • Cardiff, United Kingdom, CF14 4XW
        • University Hospital of Whales Health Park
      • Carshalton, United Kingdom
        • Epsom St. Helier
      • Derby, United Kingdom, DE22 3NE
        • Royal Derby Hospital
      • Dundee, United Kingdom, DD1 9SY
        • Ninewells Hospital
      • Glasgow, United Kingdom, G51 4TF
        • Queen Elizabeth University Hospital
      • Leicester, United Kingdom
        • Leicester General Hospital
      • Liverpool, United Kingdom
        • Liverpool University Hospitals
      • London, United Kingdom, SE5 9RS
        • Kings College Hospital
      • London, United Kingdom, E1 2ES
        • The Royal London Hospital
      • Middlesbrough, United Kingdom
        • South Tees James Cook Hospital
      • Nottingham, United Kingdom, NG5 1PB
        • City Hospital
      • Salford, United Kingdom, M6 8HD
        • Salford Royal Hospital
      • Stoke-on-Trent, United Kingdom
        • Royal Stoke University Hospital
    • Belfast
      • Dundonald, Belfast, United Kingdom, BT16 1RH
        • Ulster Hospital
    • Down
      • Newry, Down, United Kingdom, BT35 8DR
        • Daisy Hill Hospital
    • Kent
      • Canterbury, Kent, United Kingdom, CT1 3NG
        • East Kent Canterbury Hospital
    • Oxford
      • Headington, Oxford, United Kingdom, OX3 7LE
        • Churchill Hospital
  • Uruguay
      • Montevideo, Uruguay, 11800
        • SEDIC Center
      • Montevideo, Uruguay
        • Cedina Center
      • Montevideo, Uruguay
        • Centro de Asistencia del Sindicato Medico del Uruguay-Institucion de Asistencia medica Privada (CASMU-IAMPP)
    • Cerro Largo
      • Melo, Cerro Largo, Uruguay
        • Canimel Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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 Measures

Outcome Measure
Time Frame
CV Death or Hospitalization for Heart Failure
Time Frame: up to 5 years
up to 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Cause specific death
Time Frame: up to 5 years
up to 5 years
Hospitalization for Heart Failure
Time Frame: up to 5 years
up to 5 years
All-cause death
Time Frame: up to 5 years
up to 5 years
All-cause Hospitalization
Time Frame: up to 5 years
up to 5 years
Hospitalization for hyperkalemia
Time Frame: up to 5 years
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Population Health Research Institute

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Michael Walsh, MD, PhD, McMaster University
  • Study Chair: PJ Devereaux, MD, PhD, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2017

Primary Completion (Actual)

March 14, 2025

Study Completion (Actual)

March 14, 2025

Study Registration Dates

First Submitted

January 11, 2017

First Submitted That Met QC Criteria

January 11, 2017

First Posted (Estimated)

January 13, 2017

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 17, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACHIEVE Trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

N/A - no plan to make IPD available to other researchers

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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