Oral Iron Supplementation in Pulmonary Hypertension

• ClinicalTrials.gov Identifier: NCT01446848
• Recruitment Status: Completed
• First Posted: October 5, 2011
• Last Update Posted: August 12, 2014
• Sponsor: The Cleveland Clinic
• Information provided by (Responsible Party): Samar Farha, MD, The Cleveland Clinic

Tracking Information

• First Submitted Date: October 3, 2011
• First Posted Date: October 5, 2011
• Last Update Posted Date: August 12, 2014
• Study Start Date: January 2012
• Actual Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Oral Iron Supplementation in Pulmonary Hypertension
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Pulmonary Arterial Hypertension

Intervention

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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 11, 2014): 6
• Original Estimated Enrollment (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

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: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01446848
• Other Study ID Numbers: RPC-2011-1026
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Samar Farha, MD, The Cleveland Clinic
• Original Responsible Party: Erika Lundgrin, The Cleveland Clinic, Principal Investigator
• Current Study Sponsor: The Cleveland Clinic
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: The Cleveland Clinic
• Verification Date: August 2014