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

Condition Intervention
Pulmonary Arterial Hypertension
 Dietary Supplement: iron supplement

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oral Iron Supplementation in Pulmonary Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]
Enrollment: 6
Study Start Date: January 2012
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility
Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01446848

Locations
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Samar Farha, MD The Cleveland Clinic
  More Information

Responsible Party: Samar Farha, MD, Staff Pulmonologist, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01446848     History of Changes
Other Study ID Numbers: RPC-2011-1026 
Study First Received: October 3, 2011
Last Updated: August 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
iron deficiency
pulmonary hypertension
iron supplements
ferrous sulfate

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
 Respiratory Tract Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 29, 2016