NCT03020303CompletedPhase 3
Aldosterone bloCkade for Health Improvement EValuation in End-stage Renal Disease
Source: ClinicalTrials.gov · Last updated 13 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 2538 (actual)
- First submitted
- 11 Jan 2017
- Start date
- 7 Jul 2017
- Primary completion date
- 14 Mar 2025
- Lead sponsor
- Hamilton Health Sciences Corporation
- Diseases
- Chronic kidney disease
- NCT number
- NCT03020303
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 2538
- From 7 Jul 2017 to the primary completion date, 14 Mar 2025
- 141 sites in 12 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently taking and unable to withdraw a mineralocorticoid receptor antagonist (i.e. spironolactone or eplerenone).
- Scheduled living related donor renal transplant
- Enrolled in another interventional trial testing a mineralocorticoid receptor antagonist or drug that has a known or likely interaction with spironolactone.
Other illness
- Known sensitivity or allergy to spironolactone
Lab values
- 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
Other
- Current or planned pregnancy or breastfeeding
- Life expectancy \< 6 months in the opinion of a treating nephrologist.
- Treating physician believes either spironolactone is either absolutely indicated or absolutely contra-indicated
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (141)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sunshine Coast University Hospital Coordinator of this site? Confirm its status | Birtinya | Australia | Unknown status |
| Monash Health Coordinator of this site? Confirm its status | Clayton | Australia | Unknown status |
| Concord Repatriation General Hospital Coordinator of this site? Confirm its status | Concord | Australia | Unknown status |
| Northern Beaches Hospital Coordinator of this site? Confirm its status | Frenchs Forest | Australia | Unknown status |
| Canberra Hospital Coordinator of this site? Confirm its status | Garran | Australia | Unknown status |
| Royal Brisbane Women's Hospital Coordinator of this site? Confirm its status | Herston | Australia | Unknown status |
| Western Health - Sunshine Hospital Coordinator of this site? Confirm its status | Saint Albans | Australia | Unknown status |
| Royal North Shore Hospital Coordinator of this site? Confirm its status | Wahroonga | Australia | Unknown status |
| Sydney Adventist Hospital Coordinator of this site? Confirm its status | Wahroonga | Australia | Unknown status |
| Princess Alexandra Hospital Coordinator of this site? Confirm its status | Woolloongabba | Australia | Unknown status |
| Irmandade da Santa Casa de Misericordia de Porto Alegre -ISCMPA Coordinator of this site? Confirm its status | Bairro Santa Teresa | Brazil | Unknown status |
| Hospital Alemao Oswaldo Cruz Coordinator of this site? Confirm its status | Bela Vista | Brazil | Unknown status |
| Felicio Rocho Foundation - Hospital Felicio Rocho Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Unknown status |
| Fundação Hospitalar São Francisco de Assis Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Unknown status |
| PROCARDIO Clinica Cardiologica Coordinator of this site? Confirm its status | Blumenau | Brazil | Unknown status |
| Fundacao Pro-Rim Coordinator of this site? Confirm its status | Boa Vista | Brazil | Unknown status |
| Hospital Arquidiocesano Consul Carlos Reneaux Coordinator of this site? Confirm its status | Brusque | Brazil | Unknown status |
| Sociedade Hospitalar Angelina Caron Coordinator of this site? Confirm its status | Campina Grande do Sul | Brazil | Unknown status |
| Instituto Pro Renal Brazil Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Santa Casa de Misericórdia de Ponta Grossa Coordinator of this site? Confirm its status | Ponta Grossa | Brazil | Unknown status |
| Hospital de Clinicas de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Medical School of Botucatu of the Paulista State University - UNESP Coordinator of this site? Confirm its status | Rubião Júnior | Brazil | Unknown status |
| Santa Casa de Misericordia de Belo Horizonte Coordinator of this site? Confirm its status | Santa Efigênia | Brazil | Unknown status |
| Praxis Pesquisa Medica S/S Coordinator of this site? Confirm its status | Santo André | Brazil | Unknown status |
| Serviço Ubaense de Nefrologia Ltda Coordinator of this site? Confirm its status | Ubá | Brazil | Unknown status |
| Santa Casa de Misericórdia de Votuporanga Coordinator of this site? Confirm its status | Votuporanga | Brazil | Unknown status |
| Foothills Hospital Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| University of Alberta Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Health Sciences North Research Institute Coordinator of this site? Confirm its status | Greater Sudbury | Canada | Unknown status |
| Queen Elizabeth II Health Science Centre Coordinator of this site? Confirm its status | Halifax | Canada | Unknown status |
| St. Joseph's Healthcare Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| Royal Inland Hospital Coordinator of this site? Confirm its status | Kamloops | Canada | Unknown status |
| Kelowna General Hospital Coordinator of this site? Confirm its status | Kelowna | Canada | Unknown status |
| Queens University at Kingston General Hospital, Division of Nephrology Coordinator of this site? Confirm its status | Kingston | Canada | Unknown status |
| Victoria Hospital Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| The Sir Mortimer B. Davis Jewish General Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Centre Hospitalier de l'Universite de Montreal (CHUM) Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| CIUSSS Hopital Maisonneuve- Rosemont Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Hopital Du Sacre Coeur de Montreal Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Ottawa Hospital Research Institute Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Penticton Regional Hospital Coordinator of this site? Confirm its status | Penticton | Canada | Unknown status |
| CHU de Quebec - L'Hôtel-Dieu de Québec Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Cape Breton Regional Hospital Coordinator of this site? Confirm its status | Sydney | Canada | Unknown status |
| Humber River Health Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| St. Josephs, Toronto Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| St. Michael's Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| St Pauls Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| The First Affiliated Hospital of Baotou Medical College Coordinator of this site? Confirm its status | Baotou | China | Unknown status |
| Beijing Tongren Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Emergency General Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Miyun District Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University Peoples Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Faw General Hospital of Jilin Province Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture Coordinator of this site? Confirm its status | Enshi | China | Unknown status |
| Huai'an First Peoples Hospital Coordinator of this site? Confirm its status | Huai'an | China | Unknown status |
| The First Hospital of Kunming Coordinator of this site? Confirm its status | Kunming | China | Unknown status |
| Gansu Baoshihua Hospital Coordinator of this site? Confirm its status | Lanzhou | China | Unknown status |
| Yichuan County Traditional Chinese Medicine Hospital Coordinator of this site? Confirm its status | Luoyang | China | Unknown status |
| Shanghai Tongji Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanxi Provincial Peoples Hospital Coordinator of this site? Confirm its status | Shanxi | China | Unknown status |
| Shuyang County Hospital of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Suqian | China | Unknown status |
| Sihong County Fenjinting Hospital Coordinator of this site? Confirm its status | Suqian | China | Unknown status |
| Tianjin Third Central Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Tianjin Fifth Central Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Tongiao City Hospital Coordinator of this site? Confirm its status | Tongliao | China | Unknown status |
| Xinxiang First Peoples Hospital Coordinator of this site? Confirm its status | Xinxiang | China | Unknown status |
| General Hospital of Xuzhou Mining Group Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
| General Hospital of Ningxia Medical University Coordinator of this site? Confirm its status | Yinchuan | China | Unknown status |
| Peoples Hospital of Yuxi City Coordinator of this site? Confirm its status | Yuxi | China | Unknown status |
| Peoples Hospital of Zhongwei Coordinator of this site? Confirm its status | Zhongwei | China | Unknown status |
| Clinefnorte CIA Ltda Coordinator of this site? Confirm its status | Quito | Ecuador | Unknown status |
| Nefromedic SA Coordinator of this site? Confirm its status | Quito | Ecuador | Unknown status |
| Aberdeen Royal Infirmary Coordinator of this site? Confirm its status | Aberdeen | United Kingdom | Unknown status |
| Belfast City Hospital Coordinator of this site? Confirm its status | Belfast | United Kingdom | Unknown status |
| Birmingham Hospitals Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Southmead Hospital Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| East Kent Canterbury Hospital Coordinator of this site? Confirm its status | Canterbury | United Kingdom | Unknown status |
| University Hospital of Whales Health Park Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Unknown status |
| Epsom St. Helier Coordinator of this site? Confirm its status | Carshalton | United Kingdom | Unknown status |
| Royal Derby Hospital Coordinator of this site? Confirm its status | Derby | United Kingdom | Unknown status |
| Ninewells Hospital Coordinator of this site? Confirm its status | Dundee | United Kingdom | Unknown status |
| Ulster Hospital Coordinator of this site? Confirm its status | Dundonald | United Kingdom | Unknown status |
| Queen Elizabeth University Hospital Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Churchill Hospital Coordinator of this site? Confirm its status | Headington | United Kingdom | Unknown status |
| Leicester General Hospital Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
| Liverpool University Hospitals Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
| Kings College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| The Royal London Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| South Tees James Cook Hospital Coordinator of this site? Confirm its status | Middlesbrough | United Kingdom | Unknown status |
| Daisy Hill Hospital Coordinator of this site? Confirm its status | Newry | United Kingdom | Unknown status |
| City Hospital Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| Salford Royal Hospital Coordinator of this site? Confirm its status | Salford | United Kingdom | Unknown status |
| Royal Stoke University Hospital Coordinator of this site? Confirm its status | Stoke-on-Trent | United Kingdom | Unknown status |
| Narayana Hrudayalaya Limited Coordinator of this site? Confirm its status | Bangalore | India | Unknown status |
| Fortis Hospitals Coordinator of this site? Confirm its status | Bengaluru | India | Unknown status |
| Vijaya Hospital Coordinator of this site? Confirm its status | Chennai | India | Unknown status |
| Apollo Hospitals Coordinator of this site? Confirm its status | Chennai | India | Unknown status |
| AIMS Hospital Mumbai Coordinator of this site? Confirm its status | Dombivali | India | Unknown status |
| Osmania General Hospital Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
| Nizams Institute of Medical Sciences Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
| AsterMedCity Coordinator of this site? Confirm its status | Kochi | India | Unknown status |
| Caritas Hospital Coordinator of this site? Confirm its status | Kottayam | India | Unknown status |
| Government Rajaji Hospital, Madurai Coordinator of this site? Confirm its status | Madurai | India | Unknown status |
| Father Muller Medical College Coordinator of this site? Confirm its status | Mangalore | India | Unknown status |
| K S Hegde Medical Academy Coordinator of this site? Confirm its status | Mangaluru | India | Unknown status |
| Ashirwad Hospital Mumbai Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| National Health and Education Society Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| Seven Star Hospital Coordinator of this site? Confirm its status | Nagpur | India | Unknown status |
| Dhadiwal Hospital Coordinator of this site? Confirm its status | Nashik | India | Unknown status |
| Madras Medical College Chennai Coordinator of this site? Confirm its status | Park Town | India | Unknown status |
| Aditya Birla Hospital Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| ACE Hospital Une Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| Nanjappa Hospitals Shimoga Coordinator of this site? Confirm its status | Shimoga | India | Unknown status |
| Hospital Pulau Pinang Coordinator of this site? Confirm its status | George Town | Malaysia | Unknown status |
| Hospital Sultanah Aminah Johor Bahru Coordinator of this site? Confirm its status | Johor Bahru | Malaysia | Unknown status |
| Hospital Kajang Coordinator of this site? Confirm its status | Kajang | Malaysia | Unknown status |
| Hospital Tengku Ampuan Rahimah Klang Coordinator of this site? Confirm its status | Klang | Malaysia | Unknown status |
| Hospital Kuala Lumpur Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Unknown status |
| University Malaya Medical Centre (UMMC) Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Unknown status |
| Hospital Sultanah Nur Zahirah Kuala Terengganu Coordinator of this site? Confirm its status | Kuala Terengganu | Malaysia | Unknown status |
| Hospital Tengku Ampuan Afzan, Kuantan Coordinator of this site? Confirm its status | Kuantan | Malaysia | Unknown status |
| Hospital Pakar Sultanah Fatimah Coordinator of this site? Confirm its status | Muar town | Malaysia | Unknown status |
| Hospital Tuanku Jaafar Seremban Coordinator of this site? Confirm its status | Seremban | Malaysia | Unknown status |
| Hospital Ampang Coordinator of this site? Confirm its status | Setapak | Malaysia | Unknown status |
| Hospital Taiping Coordinator of this site? Confirm its status | Taiping | Malaysia | Unknown status |
| Dunedin Hospital Coordinator of this site? Confirm its status | Dunedin | New Zealand | Unknown status |
| Waikato Hospital Coordinator of this site? Confirm its status | Hamilton | New Zealand | Unknown status |
| Hawkes Bay Hospital Coordinator of this site? Confirm its status | Hastings | New Zealand | Unknown status |
| Palmerston North Hospital Coordinator of this site? Confirm its status | Palmerston North | New Zealand | Unknown status |
| North Shore Hospital Coordinator of this site? Confirm its status | Takapuna | New Zealand | Unknown status |
| Whangarei Hospital Coordinator of this site? Confirm its status | Whangarei | New Zealand | Unknown status |
| Philippines General Hospital Coordinator of this site? Confirm its status | Ermita | Philippines | Unknown status |
| National Kidney and Transplant Institute Coordinator of this site? Confirm its status | Quezon City | Philippines | Unknown status |
| Canimel Center Coordinator of this site? Confirm its status | Melo | Uruguay | Unknown status |
| SEDIC Center Coordinator of this site? Confirm its status | Montevideo | Uruguay | Unknown status |
| Cedina Center Coordinator of this site? Confirm its status | Montevideo | Uruguay | Unknown status |
| Centro de Asistencia del Sindicato Medico del Uruguay-Institucion de Asistencia medica Privada (CASMU-IAMPP) Coordinator of this site? Confirm its status | Montevideo | Uruguay | Unknown status |
| Hacettepe University Hospitals Hemodialysis Center Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Osmangazi University Coordinator of this site? Confirm its status | Eskişehir | Turkey (Türkiye) | Unknown status |
| Memorial Service Hospital Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.