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OPtimizing Aldosterone Receptor Antagonist Therapy by Sodium Zirconium Cyclosilicate in Heart Failure (OPRA-HF)
EU CTIS ID: 2024-511502-24-02
What this study is testing
To demonstrate the efficacy and safety of Sodium Zirconium Cyclosilicate (SZC) in optimizing mineralocorticoid receptor antagonists (MRA) in symptomatic patients with heart failure with reduced ejection fraction (HFrEF)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Obtain signed informed consent prior to any study specific procedures.
- >18 yrs, irrespective of sex.
- LVEF ≤ 40%, with echocardiography within last 2 years including those with recovered EF later on
- NYHA II-IV.
- 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.
- On optimal treatment including ACE/ARB/ARNI, beta blockers, SGLT2 inhibitor as per physician´s judgement.
You likely can't join if
- Symptomatic hypotension (< 90/60 mmHg)
- Symptomatic and uncontrolled atrial fibrillation despite treatment, or asymp-tomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted
- QTc(f) > 550 msec
- Currently pregnant (confirmed with positive pregnancy test) or planned pregnancy or breast-feeding
- Can not sign informed consent
- eGFR < 30 ml/min/1,73 m2 (modified MDRD formula)
See the full eligibility criteria
- Obtain signed informed consent prior to any study specific procedures.
- >18 yrs, irrespective of sex.
- LVEF ≤ 40%, with echocardiography within last 2 years including those with recovered EF later on
- NYHA II-IV.
- 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.
- On optimal treatment including ACE/ARB/ARNI, beta blockers, SGLT2 inhibitor as per physician´s judgement.
- Suboptimal treatment with MRA (defined as: no use or ≤ 25 mg daily).
- AND one of followings: a. Prior hyperkalemia (S-K> 5.0 mmol/L or P-K> 4.8 mmol/L) during MRA treatment within last 24 months, and current S-K ≤ 5.0 or P-K ≤ 4.8 mmol/L b. Current S-K 4.5-5.0 mmol/L or P-K 4.3-4.8 mmol/L and potential risk of hyperkalemia as indicated by eGFR 30-45 ml/min/1,73 m2 (modi-fied MDRD formula) c. Current S-K 5.1-5.9 mmol/L or P-K 4.9-5.7 mmol/L
- Symptomatic hypotension (< 90/60 mmHg)
- Symptomatic and uncontrolled atrial fibrillation despite treatment, or asymp-tomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted
- QTc(f) > 550 msec
- Currently pregnant (confirmed with positive pregnancy test) or planned pregnancy or breast-feeding
- Can not sign informed consent
- eGFR < 30 ml/min/1,73 m2 (modified MDRD formula)
- HF due to restrictive cardiomyopathy, hypertrophic (obstructive) cardiomy-opathy or primary valvular disease
- 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 ventricular assistance device)
- Ongoing or planned dialysis
- Prior history of hypersensitivity (other than hyperkalemia) to MRA or SZC
- Advanced malignancy requiring treatment
- History of QT prolongation associated with other medication which required discontinuation of that medication
- Congenital long QT syndrome
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.