Pulmonary hypertension (PH) is a condition characterized by elevated blood pressure in the pulmonary arteries. This leads to symptoms such as shortness of breath and a significantly reduced exercise capacity, resulting in a very poor quality of life. Currently, treatment options for PH are limited. More than 60% of patients with PH develop iron deficiency. Studies have shown that this deficiency is associated with more severe symptoms, reduced exercise capacity, and even lower quality of life. Oral iron supplements are often ineffective in these patients due to impaired absorption in the intestines, caused by chronic low-grade inflammation-a common feature in PH. Intravenous iron administration can rapidly correct the deficiency, but it remains unclear whether this also leads to clinical improvements such as enhanced exercise capacity, reduced shortness of breath, and improved quality of life. Moreover, the cost-effectiveness of this treatment is still unknown. The IRON-PH study aims to answer these questions. As part of the IRON-PH study, 306 patients with pulmonary hypertension will be enrolled. Each patient will be randomized to receive either intravenous iron (ferric carboxymaltose) or intravenous placebo (NaCl 0.9%).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
306
Ferric Carboxymaltose (FCM), dosing and administration according to SmPC guidelines
Placebo, dosing and administration according to SmPC guidelines
AZORG
Aalst, Belgium
NOT_YET_RECRUITINGHôpital Erasme
Brussels, Belgium
NOT_YET_RECRUITINGZiekenhuis Oost-Limburg
Genk, Belgium
RECRUITINGAZ Groeninge
Kortrijk, Belgium
NOT_YET_RECRUITINGUZ Leuven
Leuven, Belgium
NOT_YET_RECRUITINGCHU Charleroi-Chimay
Lodelinsart, Belgium
NOT_YET_RECRUITINGCHU UCL Namur
Yvoir, Belgium
NOT_YET_RECRUITINGChange in 6MWD
Change in 6-minute walking distance (6MWD) from baseline to 24 week follow-up
Time frame: From baseline to 24 week follow-up
Change in MLHFQ
Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) score from baseline to 24 week follow-up. Total Score: Sum of all 21 items (0-105) Higher Score = Worse QoL: A higher number indicates a greater negative impact from heart failure Lower Score = Better QoL: A lower score suggests less limitation
Time frame: Baseline to 24 week follow-up
Change in EQ5D5L
Change in EuroQol 5 dimensions - 5 levels questionnaire score from baseline to 24 week follow-up EQ-5D-5L combiines responses from five health dimensions, each with five severity levels to create a 5-digit health state code, then applying country-specific "value sets" (valuation matrices) to convert this code into a single Index Score (Utility Score), ranging from \<0 (worst) to 1 (best health), plus a separate EQ-VAS score (0-100) for overall self-rated health. Dimensions: Mobility, self-care, usual activities, pain/discomfort, anxiey/depression Levels: 1 no problem, 2 slight problems, 3 moderate problems, 4 severe problems, 5 unable to/extreme problems Example of 5-digit state code: 12345 indicates no problems with mobility, slight problems with self-care, moderate problems with usual activities, severe pain/discomfort and extreme anxiety/depression
Time frame: Baseline to 24 week follow-up
Change in FSS
Change in Fatigue Severity Scale (FSS) score from baseline to 24 weeks Total score: sum of all scores (ranging between 9 - 63) Higher Scores = More Fatigue Lower Scores = Less Fatigue
Time frame: Baseline to 24 week follow-up
Developing composite clinical worsening event
The hazard ratio between treatment arms in developing the composite clinical worsening event in the overall trial population
Time frame: From first patient Day 1 (Baseline) to study completion, an average of 2 years
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