Oral Iron Supplementation in Pulmonary Hypertension

Pulmonary Arterial Hypertension Clinical Trial

Official title:

Oral Iron Supplementation in Pulmonary Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01446848
• Other study ID #: RPC-2011-1026
• Status: Completed
• Phase: N/A
• First received: October 3, 2011
• Last updated: August 11, 2014
• Start date: January 2012
• Est. completion date: August 2014

Study information

• Verified date: August 2014
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Arterial Hypertension

Intervention

Dietary Supplement:
• iron 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.

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Zinc protoporphyrin from baseline		3 months	No
Primary	Change in serum ferritin from baseline		3 months	No
Secondary	Change in serum erythropoietin from baseline		3 months	No
Secondary	Change in transferrin saturation from baseline		3 months	No
Secondary	Change in %CD34+/133+ cells from baseline		3 months	No
Secondary	Change in pulmonary arterial pressure from baseline	estimated using echocardiogram	3 months	No
Secondary	Change in six minute walk distance from baseline		3 months	No
Secondary	NYHA/WHO classification		3 months	No
Secondary	Side effects of iron supplementation		3 months	Yes
Secondary	Deaths and hospitalizations greater than 24 hours		3 months	Yes