Oral Iron Supplementation in Pulmonary Hypertension

August 11, 2014 updated by: Samar Farha, MD, The Cleveland Clinic
The purpose of this study is to investigate the effects of iron supplementation in patients with pulmonary arterial hypertension and iron deficiency.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • ferrous sulfate tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Zinc protoporphyrin from baseline
Time Frame: 3 months
3 months
Change in serum ferritin from baseline
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum erythropoietin from baseline
Time Frame: 3 months
3 months
Change in transferrin saturation from baseline
Time Frame: 3 months
3 months
Change in %CD34+/133+ cells from baseline
Time Frame: 3 months
3 months
Change in pulmonary arterial pressure from baseline
Time Frame: 3 months
estimated using echocardiogram
3 months
Change in six minute walk distance from baseline
Time Frame: 3 months
3 months
NYHA/WHO classification
Time Frame: 3 months
3 months
Side effects of iron supplementation
Time Frame: 3 months
3 months
Deaths and hospitalizations greater than 24 hours
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Samar Farha, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

October 3, 2011

First Submitted That Met QC Criteria

October 4, 2011

First Posted (ESTIMATE)

October 5, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 12, 2014

Last Update Submitted That Met QC Criteria

August 11, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RPC-2011-1026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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