Oral Iron Supplementation in Pulmonary Hypertension - Full Text View

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:

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: Dietary Supplements High Blood Pressure Iron Pulmonary Hypertension

Drug Information available for: Ferrous sulfate Ferrous sulfate heptahydrate

Genetic and Rare Diseases Information Center resources: Pulmonary Arterial Hypertension

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
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

No publications provided


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 Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Vascular Diseases	Iron Growth Substances Micronutrients Pharmacologic Actions Physiological Effects of Drugs Trace Elements

ClinicalTrials.gov processed this record on March 03, 2015