What is the effect of intravenous iron supplementation on cardiopulmonary haemodynamics, exercise capacity and quality of life in patients with IPAH and iron deficiency?

Phase 1

• Conditions: Idiopathic or familial pulmonary arterial hypertension; MedDRA version: 19.0Level: PTClassification code 10037400Term: Pulmonary hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2010-024585-22-DE
• Lead Sponsor: Imperial College Academic Healthsciences Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-17
• Last Update Posted: 26 March 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

The following entry criteria have to be chosen carefully to clearly define our study group and reduce the potential for variation.
1. Males or females aged between 16–75 years old
2. PAH which is idiopathic, heritable or associated with anorexigens.
3. Iron deficiency as defined by any one of the following criteria:
sTfR levels > 28.1 nmol/l (where sTfR analysis is available) or one of the following: Ferritin < 37 ug/l; transferrin saturations < 16.4%; iron < 10.3 umol/l.
4. Documented diagnosis of PAH by right heart catheterisation performed at any time prior to Screening showing: resting mean pulmonary artery pressure >25mmHg, pulmonary capillary wedge pressure =/< 15 mm Hg and normal or reduced cardiac output;
5. 6 minute walking distance greater than 50m at entry;
6. Stable on an unchanged PAH therapeutic regime (any combination of endothelin receptor antagonist, phosphodiesterase inhibitor or prostacyclin analogue) for at least 1 month.
7. Able to provide written informed consent prior to any study-mandated procedures
8. Female subjects of child-bearing potential are eligible to participate if they agree to use one of the following contraception methods:
• Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
o oral
o intravaginal
o transdermal
• Progestogen-only hormonal contraception associated with inhibition of ovulation:
o oral
o injectable
o implantable
• Intrauterine device (IUD)
• Intrauterine hormone-releasing system (IUS)
• Bilateral tubal occlusion
• Vasectomised partner
• Sexual abstinence

Are the trial subjects under 18? yes
Number of subjects for this age range: 5
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1. Unable to provide informed consent.
2. Clinically-significant renal disease (Creatinine clearance < 30 ml/min per 1.73 m2 calculated from CKD-Epi
http://www.qxmed.com/renal/Calculate-CKD-EPI-GFR.php) or liver disease (including serum transaminases > 3 times upper limit of normal).
3. Haemoglobin concentration <10 g/dl.
4. Patients will be excluded if any single parameter (iron, ferritin or transferritin saturation) exceeds 1x upper limit of normal (ULN) in the local lab reference range
5. Patients with moderate to severe hypophosphatemia as defined as <0.65mmol/L
6. Known to have haemoglobinopathy e.g. sickle cell disease, thalassaemia.
7. Admission to hospital related to PAH or change in PAH therapy within 1 month prior to Screening.
8. Evidence of left ventricular disease or significant lung disease on high-resolution CT scanning or lung function as judged by the investigator
9. Acute or chronic infection or inflammation.
10. Significant uncontrolled asthma as judged by the investigator, eczema or atopic allergies.
11. Females who are lactating or pregnant.
12. Individuals known to have HIV, Hepatitis B or C or Creutzfeld-Jakob disease.
13. Known hypersensitivity to FerinjectP®P or any of its excipients and any other iron supplement preparation.
14. Evidence of disturbances in utilisation of iron.
15. Significant blood loss (e.g. GI bleed) within the last 3 months or history of menorrhagia.
16. Unable to perform a Cardiopulmonary Exercise Test i.e. due to syncope or musculoskeletal factors.
17. Patients who have received an investigational medicinal product within 30 days of entering the baseline visit

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified