Oral Iron Supplementation in Pulmonary Hypertension

NCT ID: NCT01446848

Last Updated: 2014-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pulmonary Arterial Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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iron supplement

open-label iron supplement intervention group

Group Type EXPERIMENTAL

iron supplement

Intervention Type DIETARY_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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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ferrous sulfate tablets

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Samar Farha, MD

Staff Pulmonologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Samar Farha, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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RPC-2011-1026

Identifier Type: -

Identifier Source: org_study_id

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