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

February 22, 2023 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

Recruiting

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 (Anticipated)

2750

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 Contact

Study Contact Backup

Study Locations

  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Recruiting
        • Concord Repatriation General Hospital
        • Contact:
      • Frenchs Forest, New South Wales, Australia, 2086
      • Wahroonga, New South Wales, Australia, 2076
      • Wahroonga, New South Wales, Australia, 2076
    • Queensland
      • Birtinya, Queensland, Australia, 4575
      • Herston, Queensland, Australia, 4029
        • Recruiting
        • Royal Brisbane Women's Hospital
        • Contact:
      • Woolloongabba, Queensland, Australia, 4102
        • Completed
        • Princess Alexandra Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
      • Saint Albans, Victoria, Australia, 3021
  • Brazil
    • Bahia
      • Feira De Santana, Bahia, Brazil, 44001-584
        • Withdrawn
        • Clinica Senhor do Bonfim
      • Salvador, Bahia, Brazil, 40415-065
        • Withdrawn
        • Clinica Senhor do Bonfim
    • Belo Horizonte
      • Santa Efigênia, Belo Horizonte, Brazil, 30150221
        • Not yet recruiting
        • Santa Casa de Misericordia de Belo Horizonte
        • Contact:
    • Botucatu
      • Rubiao Junior, Botucatu, Brazil, 18618-687
        • Recruiting
        • Medical School of Botucatu of the Paulista State University - UNESP
        • Contact:
        • Principal Investigator:
          • Luis Cuadrado Martin, MD
    • Joinville
      • Boa Vista, Joinville, Brazil, 89227680
        • Recruiting
        • Fundacao Pro-Rim
        • Contact:
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30110934
        • Recruiting
        • Felicio Rocho Foundation - Hospital Felício Rocho
        • Contact:
      • Belo Horizonte, Minas Gerais, Brazil, 31110580
        • Recruiting
        • Fundação Hospitalar São Francisco de Assis
        • Contact:
      • Uba, Minas Gerais, Brazil, 36500008
    • Natal
      • Petropolis, Natal, Brazil, 59020500
        • Not yet recruiting
        • Eurolatino Natal Pesquisas Medicas Ltda
        • Contact:
          • Maria S Moura de Oliveira Paiva, MD
          • Phone Number: 8499188732
          • Email: msanali@yahoo.com
    • Parana
      • Campina Grande Do Sul, Parana, Brazil, 83430000
        • Recruiting
        • Sociedade Hospitalar Angelina Caron
        • Contact:
      • Curitiba, Parana, Brazil, 80440-020
    • Porto Alegre
      • Bairro Santa Teresa, Porto Alegre, Brazil, 90020090
        • Recruiting
        • Irmandade da Santa Casa de Misericordia de Porto Alegre -ISCMPA
        • Contact:
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
        • Recruiting
        • Hospital de Clínicas de Porto Alegre
        • Contact:
    • SC
      • Blumenau, SC, Brazil, 89010500
    • Santa Catarina
      • Brusque, Santa Catarina, Brazil, 8835404
        • Not yet recruiting
        • Hospital Arquidiocesano Consul Carlos Reneaux
        • Contact:
    • Sao Paulo
      • Campinas, Sao Paulo, Brazil, 13034-685
        • Not yet recruiting
        • Sociedade Campineira de Educacao e Instrucao (SCEI)
        • Contact:
      • Santo André, Sao Paulo, Brazil, 09090 790
        • Recruiting
        • Praxis Pesquisa Medica S/S
        • Contact:
      • Votuporanga, Sao Paulo, Brazil, 15500003
  • Canada
      • Québec, Canada, G1R 2J6
        • Recruiting
        • CHU de Quebec L'Hotel-Dieu de Quebec
        • Contact:
        • Principal Investigator:
          • Sacha DeSerres, MD
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
      • Edmonton, Alberta, Canada, T6G 2G3
        • Recruiting
        • University of Alberta
        • Contact:
    • British Colombia
      • Kamloops, British Colombia, Canada, V2C 2T1
      • Kelowna, British Colombia, Canada, V1Y 1T2
      • Vancouver, British Colombia, Canada, V6Z 1Y6
        • Recruiting
        • St. Paul's Hospital
        • Contact:
        • Principal Investigator:
          • Mercedeh Kiaii, MD
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Recruiting
        • Queen Elizabeth II Health Science Centre
        • Contact:
        • Contact:
          • Steven D Soroka, MD
          • Phone Number: 9024732099
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • Recruiting
        • St. Joseph's Healthcare
        • Contact:
        • Contact:
      • Kingston, Ontario, Canada
        • Recruiting
        • Queen's University at Kingston, Division of Nephrology
        • Contact:
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • Victoria Hospital
        • Contact:
        • Principal Investigator:
          • Matthew Weir, MD
      • Ottawa, Ontario, Canada, K1y 4e9
        • Recruiting
        • Ottawa Hospital Research Institute
        • Contact:
        • Principal Investigator:
          • Debra Zimmerman, MD
      • Sudbury, Ontario, Canada, P3E 5J1
        • Recruiting
        • Health Sciences North Research Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • John P Harmon, MD
      • Toronto, Ontario, Canada, M5B 1W8
        • Recruiting
        • St. Michael's Hospital
        • Contact:
          • Ron Wald, MD
          • Phone Number: 416-864-3703
          • Email: waldr@smh.ca
        • Principal Investigator:
          • Ron Wald, MD
      • Toronto, Ontario, Canada, M6R 1B5
    • Quebec
      • Montreal, Quebec, Canada, H4J 1C5
        • Recruiting
        • Hôpital du Sacré-Coeur de Montreal
        • Contact:
        • Principal Investigator:
          • Francois Madore, MD
      • Montreal, Quebec, Canada, H1T 2M4
      • Montréal, Quebec, Canada, H2W 1T8
        • Recruiting
        • Centre Hospitalier de l'Universite de Montreal (CHUM)
        • Contact:
        • Principal Investigator:
          • Rita Suri, MD
  • Ecuador
    • Pichincha
      • Quito, Pichincha, Ecuador, 170131
        • Withdrawn
        • Nefrology
      • Quito, Pichincha, Ecuador, 170303
        • Recruiting
        • Clinefnorte CIA Ltda
        • Contact:
          • Santiago Carrasco, MD
        • Contact:
      • Quito, Pichincha, Ecuador, 170601
  • India
    • Chennai
      • Park Town, Chennai, India, 600003
        • Not yet recruiting
        • Madras Medical College Chennai
        • Contact:
    • Karnataka
      • Bangalore, Karnataka, India, 560034
        • Not yet recruiting
        • CBCI Society for Medical Education
        • Contact:
      • Bangalore, Karnataka, India, 560099
        • Recruiting
        • Narayana Hrudayalaya Limited
        • Contact:
      • Bengaluru, Karnataka, India, 560076
        • Recruiting
        • Fortis Hospitals
        • Contact:
      • Mangaluru, Karnataka, India, 575018
      • Shimoga, Karnataka, India, 577201
    • Kerala
      • Cochin, Kerala, India, 682027
        • Completed
        • AsterMedCity
      • Kottayam, Kerala, India, 686630
    • Maharashtra
      • Dombivli, Maharashtra, India, 421203
      • Mumbai, Maharashtra, India, 400016
        • Not yet recruiting
        • National Health and Education Society
        • Contact:
      • Mumbai, Maharashtra, India, 421004
        • Recruiting
        • Ashirwad Hospital Mumbai
        • Contact:
      • Nashik, Maharashtra, India, 422002
        • Terminated
        • Dhadiwal Hospital
      • Pune, Maharashtra, India, 411004
      • Pune, Maharashtra, India, 411033
        • Recruiting
        • Aditya Birla Hospital
        • Contact:
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600081
      • Chennai, Tamil Nadu, India, 600026
      • Puducherry, Tamil Nadu, India, 607402
        • Not yet recruiting
        • Mahatma Gandhi Medical College and Reserach Institute
        • Contact:
    • Telangana
      • Hyderabad, Telangana, India, 500082
        • Recruiting
        • Nizam's Institute of Medical Sciences
        • Contact:
      • Susundra, Telangana, India, 500003
        • Not yet recruiting
        • Yashoda Hospital
        • Contact:
    • Telegana
      • Hyderabad, Telegana, India, 500012
  • Malaysia
      • Kuala Lumpur, Malaysia, 42896
      • Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • University Malaya Medical Centre (UMMC)
        • Contact:
      • Kuala Terengganu, Malaysia, 33158
        • Recruiting
        • Hospital Sultanah Nur Zahirah Kuala Terengganu
        • Contact:
      • Kuantan, Malaysia, 29142
        • Recruiting
        • Hospital Tengku Ampuan Afzan, Kuantan
        • Contact:
      • Seremban, Malaysia, 25167
      • Setapak, Malaysia, 53200
    • Johor
      • Johor Bahru, Johor, Malaysia, 80100
        • Recruiting
        • Hospital Sultanah Aminah, Johor Bahru
        • Contact:
      • Muar, Johor, Malaysia
        • Not yet recruiting
        • Hospital Pakar Sultanah Fatimah
        • Contact:
    • Kuala Lumpur
      • Cheras, Kuala Lumpur, Malaysia, 56000
        • Withdrawn
        • Universiti Kebangsaan Malaysia
    • Perak
      • Ipoh, Perak, Malaysia, 30990
        • Withdrawn
        • Hospital Raja Permaisuri Bainun, Ipoh
      • Taiping, Perak, Malaysia, 34000
    • Pulau Pinang
      • George Town, Pulau Pinang, Malaysia, 10990
    • Selangor
      • Batu Caves, Selangor, Malaysia
        • Withdrawn
        • Universiti Teknologi Mara (UiTM)
      • Kajang, Selangor, Malaysia, 43000
      • Klang, Selangor, Malaysia, 41200
        • Recruiting
        • Hospital Tengku Ampuan Rahimah Klang
        • Contact:
  • New Zealand
  • Philippines
    • Manila
      • Ermita, Manila, Philippines, 1000
        • Recruiting
        • Philippines General Hospital
        • Contact:
      • Pasig City, Manila, Philippines, 1605
        • Withdrawn
        • Medical City General Hospital
      • Quezon City, Manila, Philippines, 1101
        • Recruiting
        • National Kidney and Transplant Institute
        • Contact:
  • United Kingdom
  • Uruguay
      • Montevideo, Uruguay, 11600
        • Not yet recruiting
        • Hospital de Clinicas "Dr. Manuel Quintela"
        • Contact:
      • Montevideo, Uruguay, 11800
        • Recruiting
        • SEDIC Center
        • Contact:
      • Montevideo, Uruguay
      • Montevideo, Uruguay
        • Recruiting
        • Centro de Asistencia del Sindicato Medico del Uruguay-Institucion de Asistencia medica Privada (CASMU-IAMPP)
        • Contact:
    • Cerro Largo
      • Melo, Cerro Largo, Uruguay
        • Not yet recruiting
        • Canimel Center
        • Contact:

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

Genders Eligible for Study

All

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 (Anticipated)

December 1, 2024

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

January 11, 2017

First Submitted That Met QC Criteria

January 11, 2017

First Posted (Estimate)

January 13, 2017

Study Record Updates

Last Update Posted (Actual)

February 24, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACHIEVE

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.

Clinical Trials on Endstage Renal Disease

Clinical Trials on Placebo Oral Tablet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe