The Impact of IV Iron on Exercise Capacity and Quality of Life in Pulmonary Hypertension
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorZiekenhuis Oost-Limburg
About this trial
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%).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years of age
WHO functional class II - IV
Iron deficiency defined as TSAT <21% (no more than ≥3 months old at randomization)
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.
Disqualifiers
Screening haemoglobin < 8 g/dl or >15 g/dl
Ferritin > 700 ng/mL
Known hypersensitivity reaction to any component of FCM
Group 1 PH associated with veno-occlusive diseases.
Trial design
Design model
Parallel
Treatments tested in this trial
Ferric Carboxymaltose (FCM)
DrugFerric Carboxymaltose (FCM), dosing and administration according to SmPC guidelines
Sodium Chloride (NaCl) 0.9 %
DrugPlacebo, dosing and administration according to SmPC guidelines
Treatment groups
306 Participants
are divided into 2 treatment groupsGroup A: Ferric carboxymaltoseExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in 6MWD
Change in 6-minute walking distance (6MWD) from baseline to 24 week follow-up
Time frame
From baseline to 24 week follow-upSecondary outcomes
1
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-up2
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-up3
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-up4
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ziekenhuis Oost-Limburg
Lead sponsor
Federal Knowledge Centre (KCE)
Collaborator
Source ClinicalTrials.gov