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COMPLETED
NCT03020303
PHASE3

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

Sponsor: Hamilton Health Sciences Corporation

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2538

Start Date

2017-07-07

Completion Date

2025-03-14

Last Updated

2026-08-13

Healthy Volunteers

No

Interventions

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.

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.

Locations (141)

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

And 41 more locations on ClinicalTrials.gov