Oral Iron Supplementation in Pulmonary Hypertension

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Samar Farha, MD, The Cleveland Clinic

ClinicalTrials.gov Identifier:

NCT01446848

First received: October 3, 2011

Last updated: August 11, 2014

Last verified: August 2014

History of Changes

Tracking Information

First Received Date ^ICMJE

October 3, 2011

Last Updated Date

August 11, 2014

Start Date ^ICMJE

January 2012

Primary Completion Date

August 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in Zinc protoporphyrin from baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Change in serum ferritin from baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01446848 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in serum erythropoietin from baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Change in transferrin saturation from baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Change in %CD34+/133+ cells from baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Change in pulmonary arterial pressure from baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
estimated using echocardiogram
Change in six minute walk distance from baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
NYHA/WHO classification [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Side effects of iron supplementation [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Deaths and hospitalizations greater than 24 hours [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Oral Iron Supplementation in Pulmonary Hypertension

Official Title ^ICMJE

Oral Iron Supplementation in Pulmonary Hypertension

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Pulmonary Arterial Hypertension

Intervention ^ICMJE

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

Study Arm (s)

Experimental: iron supplement

open-label iron supplement intervention group

Intervention: Dietary Supplement: iron supplement

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2014

Primary Completion Date

August 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

21 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01446848

Other Study ID Numbers ^ICMJE

RPC-2011-1026

Has Data Monitoring Committee

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Samar Farha, MD, The Cleveland Clinic

Study Sponsor ^ICMJE

The Cleveland Clinic

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Samar Farha, MD

The Cleveland Clinic

Information Provided By

The Cleveland Clinic

Verification Date

August 2014

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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