Aldosterone bloCkade for Health Improvement EValuation in End-stage Renal Disease
NCT ID: NCT03020303
Last Updated: 2025-03-20
Study Results
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Basic Information
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COMPLETED
PHASE3
2538 participants
INTERVENTIONAL
2017-07-07
2025-03-14
Brief Summary
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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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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Placebo Oral Tablet
A tablet with no active medication that will be an exact match of the active spironolactone in taste and appearance
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.
Spironolactone 25 MG Tablet
25 mg of active spironolactone in tablet form
Spironolactone 25Mg Tablet
Randomized participants will receive a study supply of spironolactone 25 mg tablets. They will be instructed to take 1 tablet daily.
Interventions
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Spironolactone 25Mg Tablet
Randomized participants will receive a study supply of spironolactone 25 mg tablets. They will be instructed to take 1 tablet daily.
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.
Eligibility Criteria
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Inclusion Criteria
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. 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
18 Years
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Population Health Research Institute
OTHER
Responsible Party
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Principal Investigators
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Michael Walsh, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
McMaster University
PJ Devereaux, MD, PhD
Role: STUDY_CHAIR
McMaster University
Locations
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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
Royal North Shore Hospital
Wahroonga, New South Wales, Australia
Sydney Adventist Hospital
Wahroonga, New South Wales, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Royal Brisbane Women's Hospital
Herston, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Monash Health
Clayton, Victoria, Australia
Western Health - Sunshine Hospital
Saint Albans, Victoria, Australia
Santa Casa de Misericordia de Belo Horizonte
Santa Efigênia, Belo Horizonte, Brazil
Medical School of Botucatu of the Paulista State University - UNESP
Rubião Júnior, Botucatu, Brazil
Fundacao Pro-Rim
Boa Vista, Joinville, Brazil
Felicio Rocho Foundation - Hospital Felicio Rocho
Belo Horizonte, Minas Gerais, Brazil
Fundacao Hospitalar Sao Francisco de Assis
Belo Horizonte, Minas Gerais, Brazil
Servico Ubaense de Nefrologia Ltda
Ubá, Minas Gerais, Brazil
Sociedade Hospitalar Angelina Caron
Campina Grande do Sul, Paraná, Brazil
Instituto Pro Renal Brazil
Curitiba, Paraná, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre -ISCMPA
Bairro Santa Teresa, Porto Alegre, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Arquidiocesano Consul Carlos Reneaux
Brusque, Santa Catarina, Brazil
PROCARDIO Clinica Cardiologica
Blumenau, South Carolina, Brazil
Praxis Pesquisa Medica S/S
Santo André, São Paulo, Brazil
Santa Casa de Misericordia de Votuporanga
Votuporanga, São Paulo, Brazil
Hospital Alemao Oswaldo Cruz
Bela Vista, , Brazil
Santa Casa de Misericordia de Ponta Grossa
Ponta Grossa, , Brazil
Foothills Hospital
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Royal Inland Hospital
Kamloops, British Colombia, Canada
Kelowna General Hospital
Kelowna, British Colombia, Canada
St. Pauls Hospital
Vancouver, British Colombia, Canada
Penticton Regional Hospital
Penticton, British Columbia, Canada
Queen Elizabeth II Health Science Centre
Halifax, Nova Scotia, Canada
Cape Breton Regional Hospital
Sydney, Nova Scotia, Canada
Health Sciences North Research Institute
Greater Sudbury, Ontario, Canada
St. Joseph's Healthcare
Hamilton, Ontario, Canada
Queens University at Kingston General Hospital, Division of Nephrology
Kingston, Ontario, Canada
Victoria Hospital
London, Ontario, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
St. Josephs, Toronto
Toronto, Ontario, Canada
Humber River Health
Toronto, Ontario, Canada
CIUSSS Hopital Maisonneuve- Rosemont
Montreal, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
The Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, Canada
CHU de Quebec L'Hotel-Dieu de Quebec
Québec, Quebec, Canada
Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University Peoples Hospital
Beijing, Beijing Municipality, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
The First Affiliated Hospital of Baotou Medical College
Baotou, , China
Beijing Miyun District Hospital
Beijing, , China
Beijing Tongren Hospital, Capital Medical University
Beijing, , China
Emergency General Hospital
Beijing, , China
Faw General Hospital of Jilin Province
Changchun, , China
The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture
Enshi, , China
Huai'an First Peoples Hospital
Huai'an, , China
The First Hospital of Kunming
Kunming, , China
Gansu Baoshihua Hospital
Lanzhou, , China
Yichuan County Traditional Chinese Medicine Hospital
Luoyang, , China
Shanghai Tongji Hospital
Shanghai, , China
Shanxi Provincial Peoples Hospital
Shanxi, , China
Shuyang County Hospital of Traditional Chinese Medicine
Suqian, , China
Sihong County Fenjinting Hospital
Suqian, , China
Tianjin Fifth Central Hospital
Tianjin, , China
Tianjin Third Central Hospital
Tianjin, , China
Tongiao City Hospital
Tongliao, , China
Xinxiang First Peoples Hospital
Xinxiang, , China
General Hospital of Xuzhou Mining Group
Xuzhou, , China
Peoples Hospital of Yuxi City
Yuxi, , China
Peoples Hospital of Zhongwei
Zhongwei, , China
Clinefnorte CIA Ltda
Quito, Pichincha, Ecuador
Nefromedic SA
Quito, Pichincha, Ecuador
Madras Medical College Chennai
Park Town, Chennai, India
Narayana Hrudayalaya Limited
Bangalore, Karnataka, India
Fortis Hospitals
Bengaluru, Karnataka, India
K S Hegde Medical Academy
Mangaluru, Karnataka, India
Nanjappa Hospitals Shimoga
Shimoga, Karnataka, India
AsterMedCity
Kochi, Kerala, India
Caritas Hospital
Kottayam, Kerala, India
AIMS Hospital Mumbai
Dombivali, Maharashtra, India
National Health and Education Society
Mumbai, Maharashtra, India
Ashirwad Hospital Mumbai
Mumbai, Maharashtra, India
Dhadiwal Hospital
Nashik, Maharashtra, India
ACE Hospital Une
Pune, Maharashtra, India
Aditya Birla Hospital
Pune, Maharashtra, India
Vijaya Hospital
Chennai, Tamil Nadu, India
Apollo Hospitals
Chennai, Tamil Nadu, India
Nizams Institute of Medical Sciences
Hyderabad, Telangana, India
Osmania General Hospital
Hyderabad, Telegana, India
Government Rajaji Hospital, Madurai
Madurai, , India
Father Muller Medical College
Mangalore, , India
Seven Star Hospital
Nagpur, , India
Hospital Sultanah Aminah, Johor Bahru
Johor Bahru, Johor, Malaysia
Hospital Pakar Sultanah Fatimah
Muar town, Johor, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, Malaysia
University Malaya Medical Centre (UMMC)
Kuala Lumpur, Kuala Lumpur, Malaysia
Hospital Sultanah Nur Zahirah Kuala Terengganu
Kuala Terengganu, Kuala Terengganu, Malaysia
Hospital Taiping
Taiping, Perak, Malaysia
Hospital Pulau Pinang
George Town, Pulau Pinang, Malaysia
Hospital Kajang
Kajang, Selangor, Malaysia
Hospital Tengku Ampuan Rahimah Klang
Klang, Selangor, Malaysia
Hospital Tengku Ampuan Afzan, Kuantan
Kuantan, , Malaysia
Hospital Tuanku Jaafar, Seremban
Seremban, , Malaysia
Hospital Ampang
Setapak, , Malaysia
North Shore Hospital
Takapuna, Auckland, New Zealand
Waikato Hospital
Hamilton, Waikato Region, New Zealand
Dunedin Hospital
Dunedin, , New Zealand
Hawkes Bay Hospital
Hastings, , New Zealand
Palmerston North Hospital
Palmerston North, , New Zealand
Whangarei Hospital
Whangarei, , New Zealand
Philippines General Hospital
Ermita, Manila, Philippines
National Kidney and Transplant Institute
Quezon City, Manila, Philippines
Hacettepe University Hospitals Hemodialysis Center
Ankara, , Turkey (Türkiye)
Osmangazi University
Eskişehir, , Turkey (Türkiye)
Memorial Service Hospital
Istanbul, , Turkey (Türkiye)
Ulster Hospital
Dundonald, Belfast, United Kingdom
Southmead Hospital
Bristol, Bristol, United Kingdom
University Hospital of Whales Health Park
Cardiff, Cardiff, United Kingdom
Daisy Hill Hospital
Newry, Down, United Kingdom
Queen Elizabeth University Hospital
Glasgow, Glasgow, United Kingdom
East Kent Canterbury Hospital
Canterbury, Kent, United Kingdom
The Royal London Hospital
London, London, United Kingdom
Kings College Hospital
London, London, United Kingdom
City Hospital
Nottingham, Nottingham, United Kingdom
Churchill Hospital
Headington, Oxford, United Kingdom
Salford Royal Hospital
Salford, Salford, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, , United Kingdom
Belfast City Hospital
Belfast, , United Kingdom
Birmingham Hospitals
Birmingham, , United Kingdom
Epsom St. Helier
Carshalton, , United Kingdom
Royal Derby Hospital
Derby, , United Kingdom
Ninewells Hospital
Dundee, , United Kingdom
Leicester General Hospital
Leicester, , United Kingdom
Liverpool University Hospitals
Liverpool, , United Kingdom
South Tees James Cook Hospital
Middlesbrough, , United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, , United Kingdom
Canimel Center
Melo, Departamento de Cerro Largo, Uruguay
SEDIC Center
Montevideo, Montevideo Department, Uruguay
Cedina Center
Montevideo, , Uruguay
Centro de Asistencia del Sindicato Medico del Uruguay-Institucion de Asistencia medica Privada (CASMU-IAMPP)
Montevideo, , Uruguay
Countries
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References
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Quach K, Lvtvyn L, Baigent C, Bueti J, Garg AX, Hawley C, Haynes R, Manns B, Perkovic V, Rabbat CG, Wald R, Walsh M. The Safety and Efficacy of Mineralocorticoid Receptor Antagonists in Patients Who Require Dialysis: A Systematic Review and Meta-analysis. Am J Kidney Dis. 2016 Oct;68(4):591-598. doi: 10.1053/j.ajkd.2016.04.011. Epub 2016 Jun 3.
Walsh M, Manns B, Garg AX, Bueti J, Rabbat C, Smyth A, Tyrwhitt J, Bosch J, Gao P, Devereaux PJ, Wald R. The Safety of Eplerenone in Hemodialysis Patients: A Noninferiority Randomized Controlled Trial. Clin J Am Soc Nephrol. 2015 Sep 4;10(9):1602-8. doi: 10.2215/CJN.12371214. Epub 2015 Jul 2.
Walsh M, Collister D, Gallagher M, Mark PB, de Zoysa JR, Tyrwhitt J, Tennankore K, Reis G, Xavier D, Liu WJ, Zuo L, Wang AY, Felix C, Sola L, Arici M, Villanueva R, Jha V, Precoma D, Rabbat CG, Alavudeen SS, Faruqui AR, Lopez-Flecher M, Pyne L, Wald R, Yuan F, Balasubramanian K, Lee SF, Kuptsova A, Christou C, Devereaux PJ; ACHIEVE Investigators. Spironolactone versus placebo in patients undergoing maintenance dialysis (ACHIEVE): an international, parallel-group, randomised controlled trial. Lancet. 2025 Aug 16;406(10504):695-704. doi: 10.1016/S0140-6736(25)01198-5.
Walsh M, Collister D, Gallagher M, Mark PB, de Zoysa JR, Tyrwhitt J, Tennankore K, Sola L, Reis G, Xavier D, Villanueva R, Liu WJ, Felix C, Zuo L, Arici M, Jha V, Wald R, Wang AY, Faruqui AR, Yuan F, Lee SF, Kuptsova A, Christou C, Devereaux PJ; ACHIEVE Investigators. The Aldosterone Blockade for Health Improvement Evaluation in End-Stage Renal Disease (ACHIEVE) Trial: Rationale and Clinical Research Protocol. Can J Kidney Health Dis. 2025 Jun 3;12:20543581251348187. doi: 10.1177/20543581251348187. eCollection 2025.
Huang B, McDowell G, Rao A, Lip GYH. Mineralocorticoid receptor antagonist for chronic kidney disease, risk or benefit? J Hypertens. 2024 Mar 1;42(3):396-398. doi: 10.1097/HJH.0000000000003643. Epub 2024 Feb 1. No abstract available.
Soomro QH, Charytan DM. Mineralocorticoid Receptor Antagonists and Cardiovascular Health with Kidney Failure. Clin J Am Soc Nephrol. 2021 Jun;16(6):843-845. doi: 10.2215/CJN.04460421. No abstract available.
Collister D, Mbuagbaw L, Guyatt G, Devereaux PJ, Tennankore KK, Reis G, Sola L, Xavier D, Jha V, Gallagher M, Dans AL, Liu W, de Zoysa J, Felix C, Mark PB, Li Z, Tyrwhitt J, Wilkinson J, Sheridan P, Yuan F, Walsh M; ACHIEVE investigators. Three week compared to seven week run-in period length and the assessment of pre-randomization adherence: A study within a trial. Contemp Clin Trials. 2021 Aug;107:106466. doi: 10.1016/j.cct.2021.106466. Epub 2021 Jun 5.
Hasegawa T, Nishiwaki H, Ota E, Levack WM, Noma H. Aldosterone antagonists for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2021 Feb 15;2(2):CD013109. doi: 10.1002/14651858.CD013109.pub2.
Other Identifiers
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ACHIEVE Trial
Identifier Type: -
Identifier Source: org_study_id
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