Oral Iron Supplementation in Pulmonary Hypertension

Tracking Information
First Submitted Date ICMJE	October 3, 2011
First Posted Date ICMJE	October 5, 2011
Last Update Posted Date	August 12, 2014
Study Start Date ICMJE	January 2012
Actual Primary Completion Date	August 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: October 4, 2011)	Change in Zinc protoporphyrin from baseline [ Time Frame: 3 months ]; Change in serum ferritin from baseline [ Time Frame: 3 months ]
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; (submitted: October 4, 2011)	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 ]
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 Applicable
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (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 Arms	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
Actual Enrollment ICMJE; (submitted: August 11, 2014)	6
Original Estimated Enrollment ICMJE; (submitted: October 4, 2011)	25
Actual Study Completion Date	August 2014
Actual 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
Sex/Gender	Sexes Eligible for Study: All
Ages	21 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
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	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	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
PRS Account	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