We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Oral Iron Supplementation in Pulmonary Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01446848
Recruitment Status : Completed
First Posted : October 5, 2011
Last Update Posted : August 12, 2014
Sponsor:
Information provided by (Responsible Party):
Samar Farha, MD, The Cleveland Clinic

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to investigate the effects of iron supplementation in patients with pulmonary arterial hypertension and iron deficiency.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Dietary Supplement: iron supplement Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oral Iron Supplementation in Pulmonary Hypertension
Study Start Date : January 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: ferrous sulfate tablets


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in Zinc protoporphyrin from baseline [ Time Frame: 3 months ]
  2. Change in serum ferritin from baseline [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Change in serum erythropoietin from baseline [ Time Frame: 3 months ]
  2. Change in transferrin saturation from baseline [ Time Frame: 3 months ]
  3. Change in %CD34+/133+ cells from baseline [ Time Frame: 3 months ]
  4. Change in pulmonary arterial pressure from baseline [ Time Frame: 3 months ]
    estimated using echocardiogram

  5. Change in six minute walk distance from baseline [ Time Frame: 3 months ]
  6. NYHA/WHO classification [ Time Frame: 3 months ]
  7. Side effects of iron supplementation [ Time Frame: 3 months ]
  8. Deaths and hospitalizations greater than 24 hours [ Time Frame: 3 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01446848


Locations
Layout table for location information
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Layout table for investigator information
Principal Investigator: Samar Farha, MD The Cleveland Clinic
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Samar Farha, MD, Staff Pulmonologist, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01446848    
Other Study ID Numbers: RPC-2011-1026
First Posted: October 5, 2011    Key Record Dates
Last Update Posted: August 12, 2014
Last Verified: August 2014
Keywords provided by Samar Farha, MD, The Cleveland Clinic:
iron deficiency
pulmonary hypertension
iron supplements
ferrous sulfate
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension, Pulmonary
Pulmonary Arterial Hypertension
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases