2025-522936-14-00
尚未招募
4 期
A randomized, double-blind, placebo-controlled, multicentre trial, assessing the impact of ferric carboxymaltose on exercise capacity and functional status in pulmonary hypertension (IRON-PH)
概览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 306
- 试验地点
- 7
- 主要终点
- Change in 6MWD from baseline to 24 weeks follow-up
概览
简要总结
The primary objective is to determine if in patients with pulmonary hypertension that are suffering from iron deficiency treatment with FCM with dosing defined according to the SmPC in comparison to matching placebo leads to a significant improvement in exercise capacity measured as the change in 6 minute walking distance from baseline to 24 weeks of follow-up.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age
- •WHO functional class II – IV
- •Iron deficiency defined as TSAT <21% (no more than ≥3 months old at randomization)
- •PH defined by echocardiography and/or right heart catheterization (RHC) according to the following WHO groups: - Group 1 PH: • Patients with a diagnosis of idiopathic PAH, hereditary PAH, drug induced PAH or PAH and associated with CTD or CHD (historical RHC available) on stable and optimized doses of PAH targeted therapies for at least 4 weeks before randomization. • Echocardiographic evidence of a high or intermediate probability for PH as per 2022 ESC PH guidelines. - Group 2 PH and baseline LVEF > 50% on imaging modality within last 6 months before randomization and on stable doses of loop diuretics and HFpEF therapies for 4 weeks. Group 2 PH can be included based on echocardiography or RHC.: • Echocardiography (<6mo before randomization): - Presence of LVH or LA-enlargement - E/e’ >15 (at rest or exercise) - TRVmax >2.8 m/s (at rest) or mPAP/CO>3 mHg/L/min (exercise) or echocardiographic evidence of high or intermediate probability for PH as per 2022 ESC PH guidelines. • RHC (<6mo before randomization) - mPAP > 20 mmHg - PCWP > 15 mmHg at rest or PCWP/CO-slope > 2mmHg/L/min or exercise PCWP>25mmHg, or PCWP 13-15 mmHg with elevation ≥18mmHg after 500 cc Fluid Challenge - Group 4 PH: • Inoperable CTEPH • persistent/recurrent CTEPH (> 1 year after endarterectomy or > 6 months after balloon pulmonary angioplasty) ineligible for balloon pulmonary angioplasty. • Echocardiographic evidence of a high or intermediate probability for PH as per 2022 ESC PH guidelines.
排除标准
- •Screening haemoglobin < 8 g/dl or >15 g/dl
- •Haemodialysis or peritoneal dialysis (current or planned within the next 24 weeks)
- •Inability to return for follow up visits within the necessary windows
- •Concurrently in a study with another investigational product
- •Uncorrected moderate to severe aortic stenosis (AVA <1.5cm² and mean gradient >20 mmHg) or severe valvular regurgitation (except tricuspid regurgitation)
- •Impression by investigator that patient cannot perform a 6MWT
- •Active infection as judged by the investigator
- •Ferritin > 700 ng/mL
- •Known hypersensitivity reaction to any component of FCM
- •Group 1 PH associated with veno-occlusive diseases
结局指标
主要结局
Change in 6MWD from baseline to 24 weeks follow-up
Change in 6MWD from baseline to 24 weeks follow-up
次要结局
- Change in EQ5D from baseline to 24 weeks follow-up
- Change in MLHFQ from baseline to 24 weeks follow-up
- Change in FSS from baseline to 24 weeks follow-up
- The hazard ratio between treatment arms in developing a composite clinical worsening event in the overall trial population (from first patient visit to last patient visit)
研究者
Katrien Tartaglia
Scientific
Ziekenhuis Oost Limburg
研究点 (7)
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