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Oral Iron Supplementation in Pulmonary Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Samar Farha, MD, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01446848
First received: October 3, 2011
Last updated: August 11, 2014
Last verified: August 2014

October 3, 2011
August 11, 2014
January 2012
August 2014   (final data collection date for primary outcome measure)
  • Change in Zinc protoporphyrin from baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Change in serum ferritin from baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01446848 on ClinicalTrials.gov Archive Site
  • Change in serum erythropoietin from baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Change in transferrin saturation from baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Change in %CD34+/133+ cells from baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Change in pulmonary arterial pressure from baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    estimated using echocardiogram
  • Change in six minute walk distance from baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • NYHA/WHO classification [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Side effects of iron supplementation [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Deaths and hospitalizations greater than 24 hours [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Oral Iron Supplementation in Pulmonary Hypertension
Oral Iron Supplementation in Pulmonary Hypertension

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

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pulmonary Arterial Hypertension
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
Experimental: iron supplement
open-label iron supplement intervention group
Intervention: Dietary Supplement: iron supplement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
August 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01446848
RPC-2011-1026
No
Samar Farha, MD, The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Samar Farha, MD The Cleveland Clinic
The Cleveland Clinic
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP