Back to resultsOral Iron Supplementation in Pulmonary Hypertension
Primary Purpose
Pulmonary Arterial Hypertension
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iron supplement
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring iron deficiency, pulmonary hypertension, iron supplements, ferrous sulfate
Eligibility 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
Sites / Locations
- Cleveland Clinic Foundation
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
iron supplement
Arm Description
open-label iron supplement intervention group
Outcomes
Primary Outcome Measures
Change in Zinc protoporphyrin from baseline
Change in serum ferritin from baseline
Secondary Outcome Measures
Change in serum erythropoietin from baseline
Change in transferrin saturation from baseline
Change in %CD34+/133+ cells from baseline
Change in pulmonary arterial pressure from baseline
estimated using echocardiogram
Change in six minute walk distance from baseline
NYHA/WHO classification
Side effects of iron supplementation
Deaths and hospitalizations greater than 24 hours
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01446848
Brief Title
Oral Iron Supplementation in Pulmonary Hypertension
Official Title
Oral Iron Supplementation in Pulmonary Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
iron deficiency, pulmonary hypertension, iron supplements, ferrous sulfate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
iron supplement
Arm Type
Experimental
Arm Description
open-label iron supplement intervention group
Intervention Type
Dietary Supplement
Intervention Name(s)
iron supplement
Other Intervention Name(s)
ferrous sulfate tablets
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Zinc protoporphyrin from baseline
Time Frame
3 months
Title
Change in serum ferritin from baseline
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in serum erythropoietin from baseline
Time Frame
3 months
Title
Change in transferrin saturation from baseline
Time Frame
3 months
Title
Change in %CD34+/133+ cells from baseline
Time Frame
3 months
Title
Change in pulmonary arterial pressure from baseline
Description
estimated using echocardiogram
Time Frame
3 months
Title
Change in six minute walk distance from baseline
Time Frame
3 months
Title
NYHA/WHO classification
Time Frame
3 months
Title
Side effects of iron supplementation
Time Frame
3 months
Title
Deaths and hospitalizations greater than 24 hours
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samar Farha, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
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Oral Iron Supplementation in Pulmonary Hypertension
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