Oral Iron Supplementation in Pulmonary Hypertension

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ClinicalTrials.gov Identifier: NCT01446848

Recruitment Status : Completed

First Posted : October 5, 2011

Last Update Posted : August 12, 2014

Sponsor:

Information provided by (Responsible Party):

Samar Farha, MD, The Cleveland Clinic

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Pulmonary Arterial Hypertension	Dietary Supplement: iron supplement	Not Applicable

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 Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	6 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Oral Iron Supplementation in Pulmonary Hypertension
Study Start Date :	January 2012
Actual Primary Completion Date :	August 2014
Actual Study Completion Date :	August 2014

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Pulmonary arterial hypertension

MedlinePlus related topics: Dietary Supplements Iron Pulmonary Hypertension

Drug Information available for: Iron, elemental Ferrous sulfate Ferrous sulfate heptahydrate

Genetic and Rare Diseases Information Center resources: Pulmonary Arterial Hypertension

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: iron supplement open-label iron supplement intervention group	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. Other Name: ferrous sulfate tablets

Outcome Measures

Primary Outcome Measures :

Change in Zinc protoporphyrin from baseline [ Time Frame: 3 months ]
Change in serum ferritin from baseline [ Time Frame: 3 months ]

Secondary Outcome Measures :

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 [ Time Frame: 3 months ]
estimated using echocardiogram
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 ]

Eligibility Criteria

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Ages Eligible for Study:	21 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01446848

Locations


United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

The Cleveland Clinic

Investigators


Principal Investigator:	Samar Farha, MD	The Cleveland Clinic

More Information


Responsible Party:	Samar Farha, MD, Staff Pulmonologist, The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT01446848 History of Changes
Other Study ID Numbers:	RPC-2011-1026
First Posted:	October 5, 2011 Key Record Dates
Last Update Posted:	August 12, 2014
Last Verified:	August 2014

Keywords provided by Samar Farha, MD, The Cleveland Clinic:


iron deficiency pulmonary hypertension iron supplements ferrous sulfate

Additional relevant MeSH terms:


Hypertension Hypertension, Pulmonary Familial Primary Pulmonary Hypertension Vascular Diseases Cardiovascular Diseases Lung Diseases	Respiratory Tract Diseases Iron Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs

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