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.
연구 개요
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Porto, 포르투갈, 4200-319
- Unidade Local de Saúde São João
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Oral iron supplementation
either hydroxide polymaltose [Ferrum Haussman®] or ferrous sulfate [Ferro Gradumet®]
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Oral iron supplementation administered at the treating physician's discretion
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Hemoglobin Levels
기간: Baseline, 3-4 months, and 5-6 months
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Change from baseline in hemoglobin levels measured by laboratory blood tests
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Baseline, 3-4 months, and 5-6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Hematocrit
기간: Baseline, 3-4 months, and 5-6 months
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Change from baseline in hematocrit measured by laboratory blood tests
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Baseline, 3-4 months, and 5-6 months
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Change in Transferrin Saturation
기간: Baseline, 3-4 months, and 5-6 months
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Change from baseline in transferrin saturation measured by laboratory blood tests.
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Baseline, 3-4 months, and 5-6 months
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Change in Serum Iron
기간: Baseline, 3-4 months, and 5-6 months
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Change from baseline in serum iron measured by laboratory blood tests.
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Baseline, 3-4 months, and 5-6 months
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Change in Ferritin
기간: Baseline, 3-4 months, and 5-6 months
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Change from baseline in ferritin measured by laboratory blood tests.
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Baseline, 3-4 months, and 5-6 months
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Change in Total Iron-Binding Capacity (TIBC)
기간: Baseline, 3-4 months, and 5-6 months
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Change from baseline in TIBC measured by laboratory blood tests.
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Baseline, 3-4 months, and 5-6 months
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공동 작업자 및 조사자
수사관
- 연구 책임자: João P. Ferreira, PhD. MD., Universidade do Porto
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
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추가 정보
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