2025-521570-34-00招募中4 期
A randomised, double-blind, three parallel-group, placebo controlled superiority trial assessing the effect of intravenous versus oral iron supplementation on physical performance, quality of life and cognitive function in iron deficient FRAIL elderly IndiviDuals with cardiovascular disease (FRAIL-ID trial)
Wroclaw Medical University30 个研究点 分布在 1 个国家目标入组 396 人开始时间: 2026年6月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 396
- 试验地点
- 30
- 主要终点
- Difference in SPPB values assessed at month 12 (at the end of the treatment period) and at baseline.
研究概览
简要总结
To evaluate the effect of intravenous iron (ferric carboxymaltose, FCM) compared with oral iron (ferrous sulphate, FS) and placebo on physical performance, measured by the Short Physical Performance Battery (SPPB), in older adults with physical frailty and iron deficiency over a 12-month treatment period.
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥65 years
- •Diagnosis of CVD, i.e. defined as at least one of the following diseases: pharmacologically treated AH, AF, HF, CAD confirmed by either coronary revascularisation or previous myocardial infarction, CBVD confirmed by either cerebral revascularisation or previous stroke, PAD confirmed by either peripheral artery revascularisation or previous acute limb ischaemia;
- •Frailty status confirmed as ≥5/15 points in TFI
- •Poor or moderate physical performance confirmed as ≤9/12 points in SPPB
- •Iron deficiency (ID) defined as TSAT<20%
- •Provided written informed consent
- •Ability to comply with study treatment regimen and complete study assessments and questionnaires himself/herself
排除标准
- •Bed-bound status
- •Vitamin D3 deficiency without effective supplementation
- •Documented liver disease and/or AST or ALT above 3-fold upper laboratory limit or active hepatitis B (HBV) or hepatitis C (HCV) infection, including ongoing antiviral treatment
- •Known hypersensitivity to any of administered preparations or any of their excipients
- •Treatment with erythropoiesis stimulating factors, iv iron ther-apy and/or blood transfusion within 6 months prior to screening
- •Clinical indication that any of these treatments, i.e. erythro-poiesis stimulating factors, i.v./oral iron supplementation and/or blood transfusion, is recommended and should be administered (e.g. severe symptomatic anaemia, chronic kidney disease requir-ing renal replacement therapy)
- •Known active malignancy of any organ system, i.e. clinical evidence of current malignancy or not in stable remission for at least 3 years since completion of last treatment with exception of non-invasive basal cell carcinoma, squamous cell carcinoma of the skin or cervical intra-epithelial neoplasia
- •Participation in a device or drug trial within 3 months prior to screening or 5 half-lives, whichever period is longer, prior to screening
- •Any situation that may prevent the investigations from being performed in accordance with the trial protocol
- •Body weight below 35 kg
- •Diagnosis of dementia requiring the therapy with anti-dementia drugs
- •Diagnosis of depression requiring the therapy with anti-depres-sive drugs
- •Urgent or elective hospitalisation for whatever reasons (includ-ing percutaneous/surgical procedure requiring hospitalisation) within 4 weeks prior to screening
- •Subject temperature >38°C, or any infection requiring antibi-otic therapy within one week prior to screening
- •Haemoglobin <10 g/dL or >15 g/dL
- •Serum ferritin >400 ng/mL
- •Vitamin B12 and/or folic acid deficiency without effective sup-plementation
研究组 & 干预措施
Ferinject 50 mg żelaza/ml dyspersja do wstrzykiwań/infuzji.
Test
干预措施: Ferinject 50 mg żelaza/ml dyspersja do wstrzykiwań/infuzji. (Drug)
0,9% Sodium Chloride–Braun, 9 mg/ml, roztwór do infuzji
Placebo
干预措施: 0,9% Sodium Chloride–Braun, 9 mg/ml, roztwór do infuzji (Drug)
Placebo w postaci tabletek powlekanych
Placebo
干预措施: Placebo w postaci tabletek powlekanych (Drug)
Tardyferon, 80 mg, tabletki powlekane o przedłużonym uwalnianiu
Comparator
干预措施: Tardyferon, 80 mg, tabletki powlekane o przedłużonym uwalnianiu (Drug)
结局指标
主要结局
Difference in SPPB values assessed at month 12 (at the end of the treatment period) and at baseline.
Difference in SPPB values assessed at month 12 (at the end of the treatment period) and at baseline.
次要结局
- Difference in EQ-5D-5L scores assessed at month 12 (at the end of the treatment period) and at baseline
- Total number of falls during the 12-month treatment period
- Total number of days spent in hospital during the 12-month treatment period
研究者
prof. dr hab. Ewa Anita Jankowska
Scientific
Wroclaw Medical University
研究点 (30)
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