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Oral Iron Supplementation in Pulmonary Hypertension
This study has been completed.
Sponsor:
The Cleveland Clinic
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
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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: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Oral Iron Supplementation in Pulmonary Hypertension |
Resource links provided by NLM:
Further study details as provided by Samar Farha, MD, The Cleveland Clinic:
Primary Outcome Measures:
- Change in Zinc protoporphyrin from baseline [ Time Frame: 3 months ]
- Change in serum ferritin from baseline [ Time Frame: 3 months ]
Secondary Outcome Measures:
- 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 ]
| 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) |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01446848
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 |
Keywords provided by Samar Farha, MD, 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 July 19, 2017