Oral Iron for the Management of Iron Deficiency Anemia in SGLT2i-Treated Heart Failure Patients
Oral Iron for the Management of Iron Deficiency Anemia in SGLT2i-Treated Heart Failure Patients: A Prospective Analysis
People with heart failure often have anemia caused by low iron levels. Ongoing inflammation in heart failure can impair iron absorption, making oral iron therapy less effective.
Sodium-glucose co-transporter 2 inhibitors (SGLT2i) are medications used to treat heart failure. In addition to their cardiovascular benefits, these drugs may improve iron metabolism and support red blood cell production.
This study evaluates whether patients with heart failure and iron deficiency anemia who are receiving SGLT2i therapy respond to treatment with oral iron. Participants receive oral iron for three to four months, followed by a short period without treatment. Blood tests are used to assess changes in hemoglobin levels.
The objective of this study is to determine whether treatment with SGLT2i enhances the response to oral iron in patients with heart failure and iron deficiency anemia.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
-
-
-
Porto、ポルトガル、4200-319
- Unidade Local de Saúde São João
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 1) Previous diagnosis of heart failure, irrespective of ejection fraction;
- 2) Iron deficiency anemia defined as hemoglobin <13 g/dL in men or <12 g/dL in women, with transferrin saturation (TSAT) <20%;
- 3) Ongoing treatment with an SGLT2 inhibitor (SGLT2i) for more than 3 months at the time of enrollment.
Exclusion Criteria:
- 1) Concomitant use of intravenous iron, erythropoiesis-stimulating agents (ESAs), red blood cell transfusions, or other blood products within 3 months before enrollment;
- 2) Severe anemia, defined as hemoglobin <7 g/dL or clinical indication for transfusion;
- 3) Relevant intercurrent illnesses associated with inflammatory response (e.g., infection, acute kidney injury, or acute decompensated heart failure) within 3 months before enrollment;
- 4) Confirmed or suspected active bleeding;
- 5) End-stage renal disease or receiving renal replacement therapy;
- 6) History of any type of active cancer;
- 7) History of solid or non-solid organ transplantation.
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：なし
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
|
実験的：Oral iron supplementation
either hydroxide polymaltose [Ferrum Haussman®] or ferrous sulfate [Ferro Gradumet®]
|
Oral iron supplementation administered at the treating physician's discretion
他の名前：
|
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 |
|---|---|---|
|
Change in Hemoglobin Levels
時間枠：Baseline, 3-4 months, and 5-6 months
|
Change from baseline in hemoglobin levels measured by laboratory blood tests
|
Baseline, 3-4 months, and 5-6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Hematocrit
時間枠：Baseline, 3-4 months, and 5-6 months
|
Change from baseline in hematocrit measured by laboratory blood tests
|
Baseline, 3-4 months, and 5-6 months
|
|
Change in Transferrin Saturation
時間枠：Baseline, 3-4 months, and 5-6 months
|
Change from baseline in transferrin saturation measured by laboratory blood tests.
|
Baseline, 3-4 months, and 5-6 months
|
|
Change in Serum Iron
時間枠：Baseline, 3-4 months, and 5-6 months
|
Change from baseline in serum iron measured by laboratory blood tests.
|
Baseline, 3-4 months, and 5-6 months
|
|
Change in Ferritin
時間枠：Baseline, 3-4 months, and 5-6 months
|
Change from baseline in ferritin measured by laboratory blood tests.
|
Baseline, 3-4 months, and 5-6 months
|
|
Change in Total Iron-Binding Capacity (TIBC)
時間枠：Baseline, 3-4 months, and 5-6 months
|
Change from baseline in TIBC measured by laboratory blood tests.
|
Baseline, 3-4 months, and 5-6 months
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：João P. Ferreira, PhD. MD.、Universidade do Porto
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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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