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Can a simple pill shield dialysis Patients' hearts?

NCT ID NCT03020303

Disease control Sponsor: Hamilton Health Sciences Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This trial tests whether spironolactone, a pill already used to protect the heart in other patients, can reduce heart failure and heart-related deaths in people on dialysis. Participants take either spironolactone or a placebo daily. The study aims to see if this treatment is both safe and effective for this high-risk group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
spironolactone 25 mg tablet taken once daily
What this could lead to
If effective, spironolactone could become a standard, low-cost treatment to reduce heart failure and heart-related deaths in people on dialysis.
What could go wrong
The trial is large but still experimental for this population; spironolactone may raise potassium levels, which can be dangerous, and it may not prove beneficial in dialysis patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

2,538 people

The number who actually took part.

Started

Jul 2017

Finished

Mar 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

end stage renal failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Endstage renal disease

Contacts and locations

Locations

  • ACE Hospital Une

    Pune, Maharashtra, 411004, India

  • AIMS Hospital Mumbai

    Dombivali, Maharashtra, 421203, India

  • Aberdeen Royal Infirmary

    Aberdeen, AB23 2ZN, United Kingdom

  • Aditya Birla Hospital

    Pune, Maharashtra, 411033, India

  • Apollo Hospitals

    Chennai, Tamil Nadu, 600081, India

  • Ashirwad Hospital Mumbai

    Mumbai, Maharashtra, 421004, India

  • AsterMedCity

    Kochi, Kerala, 682027, India

  • Beijing Miyun District Hospital

    Beijing, China

  • Beijing Tongren Hospital, Capital Medical University

    Beijing, China

  • Belfast City Hospital

    Belfast, BT9 7AB, United Kingdom

  • Birmingham Hospitals

    Birmingham, United Kingdom

  • CHU de Quebec L'Hotel-Dieu de Quebec

    Québec, Quebec, G1R 2J6, Canada

  • CIUSSS Hopital Maisonneuve- Rosemont

    Montreal, Quebec, H1T 2M4, Canada

  • Canberra Hospital

    Garran, Australian Capital Territory, 2605, Australia

  • Canimel Center

    Melo, Departamento de Cerro Largo, Uruguay

  • Cape Breton Regional Hospital

    Sydney, Nova Scotia, Canada

  • Caritas Hospital

    Kottayam, Kerala, 686630, India

  • Cedina Center

    Montevideo, Uruguay

  • Centre Hospitalier de l&#39;Universite de Montreal (CHUM)

    Montreal, Quebec, H2W 1T8, Canada

  • Centro de Asistencia del Sindicato Medico del Uruguay-Institucion de Asistencia medica Privada (CASMU-IAMPP)

    Montevideo, Uruguay

  • Churchill Hospital

    Headington, Oxford, OX3 7LE, United Kingdom

  • City Hospital

    Nottingham, Nottingham, NG5 1PB, United Kingdom

  • Clinefnorte CIA Ltda

    Quito, Pichincha, 170303, Ecuador

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139, Australia

  • Daisy Hill Hospital

    Newry, Down, BT35 8DR, United Kingdom

  • Dhadiwal Hospital

    Nashik, Maharashtra, 422002, India

  • Dunedin Hospital

    Dunedin, 9016, New Zealand

  • East Kent Canterbury Hospital

    Canterbury, Kent, CT1 3NG, United Kingdom

  • Emergency General Hospital

    Beijing, China

  • Epsom St. Helier

    Carshalton, United Kingdom

  • Father Muller Medical College

    Mangalore, India

  • Faw General Hospital of Jilin Province

    Changchun, China

  • Felicio Rocho Foundation - Hospital Felicio Rocho

    Belo Horizonte, Minas Gerais, 30110934, Brazil

  • Foothills Hospital

    Calgary, Alberta, T2N 2T9, Canada

  • Fortis Hospitals

    Bengaluru, Karnataka, 560076, India

  • Fundacao Hospitalar Sao Francisco de Assis

    Belo Horizonte, Minas Gerais, 31110580, Brazil

  • Fundacao Pro-Rim

    Boa Vista, Joinville, 89227680, Brazil

  • Gansu Baoshihua Hospital

    Lanzhou, China

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, China

  • General Hospital of Xuzhou Mining Group

    Xuzhou, China

  • Government Rajaji Hospital, Madurai

    Madurai, India

  • Hacettepe University Hospitals Hemodialysis Center

    Ankara, Turkey (Türkiye)

  • Hawkes Bay Hospital

    Hastings, 4120, New Zealand

  • Health Sciences North Research Institute

    Greater Sudbury, Ontario, P3E 5J1, Canada

  • Hopital du Sacre-Coeur de Montreal

    Montreal, Quebec, H4J 1C5, Canada

  • Hospital Alemao Oswaldo Cruz

    Bela Vista, Brazil

  • Hospital Ampang

    Setapak, 53200, Malaysia

  • Hospital Arquidiocesano Consul Carlos Reneaux

    Brusque, Santa Catarina, 8835404, Brazil

  • Hospital Kajang

    Kajang, Selangor, 43000, Malaysia

  • Hospital Kuala Lumpur

    Kuala Lumpur, Kuala Lumpur, 42896, Malaysia

  • Hospital Pakar Sultanah Fatimah

    Muar town, Johor, Malaysia

  • Hospital Pulau Pinang

    George Town, Pulau Pinang, 10990, Malaysia

  • Hospital Sultanah Aminah, Johor Bahru

    Johor Bahru, Johor, 80100, Malaysia

  • Hospital Sultanah Nur Zahirah Kuala Terengganu

    Kuala Terengganu, Kuala Terengganu, 33158, Malaysia

  • Hospital Taiping

    Taiping, Perak, 34000, Malaysia

  • Hospital Tengku Ampuan Afzan, Kuantan

    Kuantan, 29142, Malaysia

  • Hospital Tengku Ampuan Rahimah Klang

    Klang, Selangor, 41200, Malaysia

  • Hospital Tuanku Jaafar, Seremban

    Seremban, 25167, Malaysia

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

  • Huai'an First Peoples Hospital

    Huai'an, China

  • Humber River Health

    Toronto, Ontario, Canada

  • Instituto Pro Renal Brazil

    Curitiba, Paraná, 80440-020, Brazil

  • Irmandade da Santa Casa de Misericordia de Porto Alegre -ISCMPA

    Bairro Santa Teresa, Porto Alegre, 90020090, Brazil

  • K S Hegde Medical Academy

    Mangaluru, Karnataka, 575018, India

  • Kelowna General Hospital

    Kelowna, British Colombia, V1Y 1T2, Canada

  • Kings College Hospital

    London, London, SE5 9RS, United Kingdom

  • Leicester General Hospital

    Leicester, United Kingdom

  • Liverpool University Hospitals

    Liverpool, United Kingdom

  • Madras Medical College Chennai

    Park Town, Chennai, 600003, India

  • Medical School of Botucatu of the Paulista State University - UNESP

    Rubião Júnior, Botucatu, 18618-687, Brazil

  • Memorial Service Hospital

    Istanbul, Turkey (Türkiye)

  • Monash Health

    Clayton, Victoria, 3168, Australia

  • Nanjappa Hospitals Shimoga

    Shimoga, Karnataka, 577201, India

  • Narayana Hrudayalaya Limited

    Bangalore, Karnataka, 560099, India

  • National Health and Education Society

    Mumbai, Maharashtra, 400016, India

  • National Kidney and Transplant Institute

    Quezon City, Manila, 1101, Philippines

  • Nefromedic SA

    Quito, Pichincha, 170601, Ecuador

  • Ninewells Hospital

    Dundee, DD1 9SY, United Kingdom

  • Nizams Institute of Medical Sciences

    Hyderabad, Telangana, 500082, India

  • North Shore Hospital

    Takapuna, Auckland, 0620, New Zealand

  • Northern Beaches Hospital

    Frenchs Forest, New South Wales, 2086, Australia

  • Osmangazi University

    Eskişehir, Turkey (Türkiye)

  • Osmania General Hospital

    Hyderabad, Telegana, 500012, India

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1Y 4E9, Canada

  • PROCARDIO Clinica Cardiologica

    Blumenau, South Carolina, 89010500, Brazil

  • Palmerston North Hospital

    Palmerston North, 4442, New Zealand

  • Peking University First Hospital

    Beijing, Beijing Municipality, China

  • Peking University Peoples Hospital

    Beijing, Beijing Municipality, China

  • Penticton Regional Hospital

    Penticton, British Columbia, Canada

  • Peoples Hospital of Yuxi City

    Yuxi, China

  • Peoples Hospital of Zhongwei

    Zhongwei, China

  • Philippines General Hospital

    Ermita, Manila, 1000, Philippines

  • Praxis Pesquisa Medica S/S

    Santo André, São Paulo, 09090 790, Brazil

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102, Australia

  • Queen Elizabeth II Health Science Centre

    Halifax, Nova Scotia, B3H 1V7, Canada

  • Queen Elizabeth University Hospital

    Glasgow, Glasgow, G51 4TF, United Kingdom

  • Queens University at Kingston General Hospital, Division of Nephrology

    Kingston, Ontario, Canada

  • Royal Brisbane Women&#39;s Hospital

    Herston, Queensland, 4029, Australia

  • Royal Derby Hospital

    Derby, DE22 3NE, United Kingdom

  • Royal Inland Hospital

    Kamloops, British Colombia, V2C 2T1, Canada

  • Royal North Shore Hospital

    Wahroonga, New South Wales, 2076, Australia

  • Royal Stoke University Hospital

    Stoke-on-Trent, United Kingdom

  • SEDIC Center

    Montevideo, Montevideo Department, 11800, Uruguay

  • Salford Royal Hospital

    Salford, Salford, M6 8HD, United Kingdom

  • Santa Casa de Misericordia de Belo Horizonte

    Santa Efigênia, Belo Horizonte, 30150221, Brazil

  • Santa Casa de Misericordia de Ponta Grossa

    Ponta Grossa, Brazil

  • Santa Casa de Misericordia de Votuporanga

    Votuporanga, São Paulo, 15500003, Brazil

  • Servico Ubaense de Nefrologia Ltda

    Ubá, Minas Gerais, 36500008, Brazil

  • Seven Star Hospital

    Nagpur, India

  • 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

  • Sociedade Hospitalar Angelina Caron

    Campina Grande do Sul, Paraná, 83430000, Brazil

  • South Tees James Cook Hospital

    Middlesbrough, United Kingdom

  • Southmead Hospital

    Bristol, Bristol, BS10 5NB, United Kingdom

  • St. Joseph's Healthcare

    Hamilton, Ontario, L8N 4A6, Canada

  • St. Josephs, Toronto

    Toronto, Ontario, M6R 1B5, Canada

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8, Canada

  • St. Pauls Hospital

    Vancouver, British Colombia, V6Z 1Y6, Canada

  • Sunshine Coast University Hospital

    Birtinya, Queensland, 4575, Australia

  • Sydney Adventist Hospital

    Wahroonga, New South Wales, 2076, Australia

  • The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture

    Enshi, China

  • The First Affiliated Hospital of Baotou Medical College

    Baotou, China

  • The First Hospital of Kunming

    Kunming, China

  • The Royal London Hospital

    London, London, E1 2ES, United Kingdom

  • The Sir Mortimer B. Davis Jewish General Hospital

    Montreal, Quebec, Canada

  • Tianjin Fifth Central Hospital

    Tianjin, China

  • Tianjin Third Central Hospital

    Tianjin, China

  • Tongiao City Hospital

    Tongliao, China

  • Ulster Hospital

    Dundonald, Belfast, BT16 1RH, United Kingdom

  • University Hospital of Whales Health Park

    Cardiff, Cardiff, CF14 4XW, United Kingdom

  • University Malaya Medical Centre (UMMC)

    Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

  • University of Alberta

    Edmonton, Alberta, T6G 2G3, Canada

  • Victoria Hospital

    London, Ontario, N6A 5W9, Canada

  • Vijaya Hospital

    Chennai, Tamil Nadu, 600026, India

  • Waikato Hospital

    Hamilton, Waikato Region, 3204, New Zealand

  • Western Health - Sunshine Hospital

    Saint Albans, Victoria, 3021, Australia

  • Whangarei Hospital

    Whangarei, 0148, New Zealand

  • Xinxiang First Peoples Hospital

    Xinxiang, China

  • Yichuan County Traditional Chinese Medicine Hospital

    Luoyang, China

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