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Potassium Reduction Initiative to Optimize RAAS Inhibition Therapy With Sodium Zirconium Cyclosilicate in Heart Failure

NCT03532009 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2021-06-15

Study results available
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Summary

This is an international, multicentre, parallel-group, randomised, double-blind, placebo controlled, phase II study to evaluate the benefits and risks of using sodium zirconium cyclosilicate (ZS) to initiate and intensify renin angiotensin aldosterone system inhibitor (RAASi) therapy in heart failure patients.

Conditions

Interventions

DRUG

Sodium Zirconium Cyclosilicate

Oral use for approximately 3 months

DRUG

Placebo

Oral use for approximately 3 months

Sponsors & Collaborators

Principal Investigators

  • Jean-Claude Tardif · Montreal Heart Institute 5000 Belanger Street, Montreal, PQ Canada H1T1C8

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
150 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-26
Primary Completion
2020-05-22
Completion
2020-05-22
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Bulgaria
  • Canada
  • Hungary
  • Poland
  • Romania
  • Russia
  • Slovakia

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03532009 on ClinicalTrials.gov