Oral Iron Supplementation in Pulmonary Hypertension

The Cleveland Clinic6 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pulmonary Arterial Hypertension

Interventions

iron supplementDIETARY_SUPPLEMENT

325 mg tablets by mouth once a day for 1 week, then twice a day for 1 week, then three times daily for the remainder of the 3-month study period.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Change in Zinc protoporphyrin from baseline

Time frame: 3 months

Change in serum ferritin from baseline

Time frame: 3 months

Secondary Outcomes

Change in serum erythropoietin from baseline

Time frame: 3 months

Change in transferrin saturation from baseline

Time frame: 3 months

Change in %CD34+/133+ cells from baseline

Time frame: 3 months

Change in pulmonary arterial pressure from baseline

estimated using echocardiogram

Time frame: 3 months

Change in six minute walk distance from baseline

Time frame: 3 months

NYHA/WHO classification

Time frame: 3 months

Side effects of iron supplementation

Time frame: 3 months

Deaths and hospitalizations greater than 24 hours

Time frame: 3 months

Data from ClinicalTrials.gov

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