Oral Iron Supplementation in Pulmonary Hypertension

Not Applicable

Completed

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Dietary Supplement: iron supplement

• Registration Number: NCT01446848
• Lead Sponsor: The Cleveland Clinic

Brief Summary

The purpose of this study is to investigate the effects of iron supplementation in patients with pulmonary arterial hypertension and iron deficiency.

Detailed Description

Pulmonary arterial hypertension (PAH) is a chronic disease associated with upregulation of hypoxia inducible-factor-1alpha (HIF-1alpha) and functional iron deficiency. The investigators are proposing a prospective, single-arm, open-label intervention to determine whether oral iron supplementation in patients with pulmonary arterial hypertension reduces markers of HIF activation and improve clinical parameters of disease. After the baseline visit, patients will be given ferrous sulfate tablets to take orally for 3 months. Outcome data will be collected at the baseline visit and at the end of the 3-month study period.

Study Timeline

• Study First Submitted: 2011-10-03
• Study First Submitted QC: 2011-10-04
• Study First Posted: 2011-10-05
• Study Start: 2012-01
• Status Verified: 2014-08
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Last Update Submitted: 2014-08-11
• Last Update Posted: 2014-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• age 21 and older
• diagnosis of idiopathic pulmonary arterial hypertension
• iron deficiency (transferrin saturation <20% and serum ferritin < 100 ug/l)

Exclusion Criteria

• active infection, malignancy, or bleeding
• hemochromatosis
• chronic inflammatory or autoimmune disease
• currently taking experimental/study medications, erythropoietin, iron supplementation, or immunosuppressants
• allergy to iron

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
iron supplement	iron supplement	open-label iron supplement intervention group

Primary Outcome Measures

Name	Time	Method
Change in Zinc protoporphyrin from baseline	3 months
Change in serum ferritin from baseline	3 months

Secondary Outcome Measures

Name	Time	Method
Side effects of iron supplementation	3 months
Change in serum erythropoietin from baseline	3 months
Change in transferrin saturation from baseline	3 months
Change in %CD34+/133+ cells from baseline	3 months
Deaths and hospitalizations greater than 24 hours	3 months
Change in pulmonary arterial pressure from baseline	3 months	estimated using echocardiogram
Change in six minute walk distance from baseline	3 months
NYHA/WHO classification	3 months

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States