EUCTR2020-005176-35-SE
Active, not recruiting
Phase 1
OPtimizing Aldosterone Receptor Antagonist Therapy by Sodium Zirconium Cyclosili-cate in Heart Failure (OPRA-HF) - OPRA-HF
Sahlgrenska University Hospital0 sites230 target enrollmentNovember 5, 2020
DrugsLokelma
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sahlgrenska University Hospital
- Enrollment
- 230
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •For inclusion in the study subjects should fulfil the following criteria:
- •1\.Obtain signed informed consent prior to any study specific procedures
- •2\.\>18 yrs, irrespective of sex
- •3\.LVEF \= 40%, with echocardiography within last 2 years
- •4\.NYHA II\-IV
- •5\.Stable heart failure as judged by local Investigator. Patients may be enrolled as an outpatient or in\-hospital at, or close to, the time of hospital discharge
- •6\.On optimal treatment with GDMT (Guideline\-Directed Medical Treatment including ACE/ARB/ARNI and beta blockers) as per physician´s judgement
- •7\.AND one of followings:
- •(1\)Prior hyperkalemia due to MRA therapy and current S\-K \= 5\.0 mmol/L;
- •(2\)Risk of hyperkalemia as indicated by eGFR 30\-45 ml/min/1\.73m2 and S\-K 4\.5\-5\.0 mmol/L;
Exclusion Criteria
- •Subjects should not enter the study if any of the following exclusion criteria are ful\-filled:
- •1\.Symptomatic hypotension (\< 90/60 mmHg)
- •2\.eGFR \< 30 ?ml/min/1,73 m2 (modified MDRD formula)
- •3\.HF due to restrictive cardiomyopathy, hypertrophic (obstructive) cardiomy\-opathy or primary valvular disease
- •4\.Current/recent (within 3 months) hospitalization due to myocardial infarc\-tion, unstable angina pectoris, coronary revascularization (percutaneous cor\-onary intervention or coronary artery bypass grafting), or other interventions (valvular repair/replacement, cardiac transplantation or implantation of a ven\-tricular assistance device)
- •5\.Ongoing or planned dialysis
- •6\.Prior history of hypersensitivity (other than hyperkalemia) to a MRA, or SZC
- •7\.Advanced malignancy requiring treatment
- •8\.History of QT prolongation associated with other medications that required discontinuation of that medication.
- •9\.Congenital long QT syndrome.
Outcomes
Primary Outcomes
Not specified
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