Actively Recruiting
Keeping RAASi Treatment With Optimal Potassium Control
Led by Fundación para la Investigación del Hospital Clínico de Valencia · Updated on 2024-08-29
78
Participants Needed
5
Research Sites
199 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase III, multicenter, randomized, open-label, parallel-group, non-inferiority, phase III clinical trial comparing CSZ (Lokelma) vs. iSRAA discontinuation/reduction and/or ARM (standard treatment).
CONDITIONS
Official Title
Keeping RAASi Treatment With Optimal Potassium Control
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have serum potassium levels of 5.5-6.5 mEq/L at patient selection visit
- Patients must have serum potassium levels of 5.0-6.5 mEq/L at randomization visit
- Patients or their legal representatives must provide informed consent before any study procedures
- Patients must be receiving standard care for heart failure including stable RAASi and/or MRA treatment for at least 4 weeks at maximum tolerated doses
- Patients must have chronic kidney disease stages 2-5 not on dialysis, with specific kidney function measures
- Patients must be 18 years or older at the time of signing consent
- Female patients of childbearing potential must have a negative pregnancy test and use effective contraception during the study and for 3 months after treatment
You will not qualify if you...
- Involvement in study planning or conduct by staff or investigators
- Previous participation in this study
- Heart failure due to specific conditions like restrictive cardiomyopathy or active myocarditis
- Recent acute heart failure, heart attack, unstable angina, stroke, or transient ischemic attack within 12 weeks
- Recent coronary or heart valve surgery within 12 weeks or planned after randomization
- Recent implantation of CRT or ICD devices or planned atrial fibrillation ablation
- Previous heart transplant or ventricular assist device implantation
- Difficulty swallowing normally
- Pregnancy, breastfeeding, or lack of effective contraception in women of childbearing potential
- Amputated limbs or pacemaker excluding some assessments
- Participation in another investigational study within the last 6 months
- Known allergy to sodium zirconium cyclosilicate or its ingredients
- Recent treatment with certain potassium-binding resins within 7 days
- Unlikely to comply with study procedures
- Family history of long QT syndrome or certain heart rhythm problems requiring immediate treatment
- History of QT prolongation from other medications
- Symptomatic or uncontrolled atrial fibrillation or sustained ventricular tachycardia (unless controlled by medication)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Hospital General Universitario Dr. Balmis
Alicante, Spain, 03010
Actively Recruiting
2
Hospital Universitario Vall d'Hebrón
Barcelona, Spain, 08035
Actively Recruiting
3
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
4
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
5
Hospital Universitario Doctor Peset
Valencia, Spain, 46017
Actively Recruiting
Research Team
J
Jose Luis Górriz
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here