OPtimizing Aldosterone Receptor Antagonist Therapy by Sodium Zirconium Cyclosili-cate in Heart Failure -Extension (OPRA-HF Extension) (OPRA-HF Extens)
A multicenter, randomized, controlled study in Sweden (n=110). This study consists of 2 phases: 1) open-label run-in within approximately 2 months, and 2) randomized, double-blinded and placebo-controlled treatment for 6 months.
The open-label phase, in turn, consists of three periods: up-titration (normally 1 - 2 weeks, and longer in some cases), correction (maximum 72 hours) and maintenance (4 - 7 weeks).
調査の概要
詳細な説明
A multicenter, randomized, controlled study in Sweden (n=110). This study consists of 2 phases: 1) open-label run-in within approximately 2 months, and 2) randomized, double-blinded and placebo-controlled treatment for 6 months.
The open-label phase, in turn, consists of three periods: up-titration (normally 1 - 2 weeks, and longer in some cases), correction (maximum 72 hours) and maintenance (4 - 7 weeks).
Eligible study population:
- >70 yrs.
- Regardless of LVEF but EF measured within past 2 years. For HFpEF echo criteria defined by ≥2 of: LV wall thickness ≥ 12 mm; LV mass index (BSA indexed LVH): male >115 g/m2, female >95 g/m2; relative wall thickness ≥0.42; E/e' ≥15 in sinus rhythm (or > 11 in the setting of atrial fibrillation); tricuspid regurgitation velocity >2.8 m/s; Left atrial volume index >34 ml/m2.
- GFR ≥ 20 mL/min/1,73 m².
- NYHA II-IV.
- On optimal treatment as per physician´s judgement including ACE/ARB/ARNI, beta blockers, SGLT2 inhibitor för HFrEF/HFmrEF, and SGLT2 inhibitors in HFpEF
- Suboptimal treatment with MRA (defined as: no use or ≤ 25 mg daily
- And one of following:
1) 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 2) 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 3) Current S-K 5.1-5.9 mmol/L or P-K 4.9-5.7 mmol/L
- Corresponding plasma K (P-K) level is 0.2 mmol lower than serum K(S-K). Hyperkalemia is defined as P-K > 4,8 mmol/L or S-K >5,0 mmol/L.
Detailed inclusion and exclusions are described in Clinical Trial Org (NCT 047809239)
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Michael Liangxiong Fu
- 電話番号：0739228176
- メール：michael.fu@gu.se
参加基準
適格基準
就学可能な年齢
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
1. >70 yrs. 2. Regardless of LVEF but EF measured within past 2 years. For HFpEF echo criteria defined by ≥2 of: LV wall thickness ≥ 12 mm; LV mass index (BSA indexed LVH): male >115 g/m2, female >95 g/m2; relative wall thickness ≥0.42; E/e' ≥15 in sinus rhythm (or > 11 in the setting of atrial fibrillation); tricuspid regurgitation velocity >2.8 m/s; Left atrial volume index >34 ml/m2.
3. GFR ≥ 20 mL/min/1,73 m². 4. NYHA II-IV. 5. On optimal treatment as per physician´s judgement including ACE/ARB/ARNI, beta blockers, SGLT2 inhibitor för HFrEF/HFmrEF, and SGLT2 inhibitors in HFpEF 6. Suboptimal treatment with MRA (defined as: no use or ≤ 25 mg daily 7. And one of following:
- 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
- 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
Current S-K 5.1-5.9 mmol/L or P-K 4.9-5.7 mmol/L
- Corresponding plasma K (P-K) level is 0.2 mmol lower than serum K(S-K). Hyperkalemia is defined as P-K > 4,8 mmol/L or S-K >5,0 mmol/L.
Exclusion Criteria:
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Sodium Zirconium Cyclosilicate treated
Sodium Zirconium Cyclosilicate
|
Sodium Zirconium Cyclosilicate
|
|
介入なし：Control
Usual care as per judgement of treating physician
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
% of optimizing MRA between Sodium Zirconium Cyclosilicate treated vs control
時間枠：From enrollment to the end of treatment at 6 months
|
The efficacy will be assessed by difference in the proportion of patients who may or may not maintain MRA at a dose ≥ 25 mg da
|
From enrollment to the end of treatment at 6 months
|
|
To demonstrate the efficacy of Sodium Zirconium Cyclosilicate (SZC) on optimizing MRA in HF, SZC vs control.
時間枠：6 mopnths
|
The efficacy will be assessed by difference in the proportion of patients who may or may not maintain MRA at a dose ≥ 25 mg da
|
6 mopnths
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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