Study of the Effects of Iron on Lung Blood Pressure at High Altitude
|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: NCT00960921|
Recruitment Status : Withdrawn (Study never started.)
First Posted : August 18, 2009
Last Update Posted : May 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hypertension, Pulmonary||Drug: Iron sucrose Drug: Normal saline||Phase 2|
Pulmonary hypertensive disorders frequently complicate hypoxic lung disease and worsen patient survival.
Hypoxia-induced pulmonary hypertension is also a major cause of morbidity at high altitude. Hypoxia causes pulmonary hypertension through hypoxic pulmonary vasoconstriction and vascular remodelling. These processes are thought to be regulated at least in part by the hypoxia-inducible factor (HIF) family of transcription factors, which coordinate intracellular responses to hypoxia throughout the body.
HIF is regulated through a cellular degradation process that requires iron as an obligate cofactor. In cultured cells HIF degradation is inhibited by reduced iron availability (by chelation with desferrioxamine) and potentiated by iron supplementation. In humans, laboratory experiments lasting eight hours have shown that acute iron supplementation blunts the pulmonary vascular response to hypoxia, while acute iron chelation with desferrioxamine enhances the response.
These findings suggest that iron may also affect the pulmonary vascular response to hypoxia over longer time periods. The purpose of this study, which will take place at high altitude in Kyrgyzstan, is to investigate whether iron supplementation can reduce pulmonary artery pressure in patients with established high altitude pulmonary hypertension.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Study of the Effects of Iron Supplementation on High Altitude Pulmonary Hypertension.|
Experimental: Iron group
Patients with high altitude pulmonary hypertension receive six intravenous infusions of iron sucrose, administered on days 0, 4, 8, 12, 16 and 20 of the study. The total study period is 28 days. Pulmonary artery systolic pressure is measured before each infusion, and again on day 28.
Drug: Iron sucrose
An intravenous infusion of 100 mg of iron is administered on days 0, 4, 8, 12, 16 and 20 of the study, giving a total of six iron infusions for each participant in the iron group over the course of the 28-day study period.
Other Name: Venofer (iron sucrose)
Placebo Comparator: Saline group
Patients with high altitude pulmonary hypertension receive six intravenous infusions of normal saline, administered on days 0, 4, 8, 12, 16 and 20 of the study. The total study period is 28 days. Pulmonary artery systolic pressure is measured before each infusion, and again on day 28.
Drug: Normal saline
An intravenous infusion of 100 ml of normal (0.9 %) saline is administered on days 0, 4, 8, 12, 16 and 20 of the study, giving a total of six saline (placebo) infusions for each participant in the saline group over the course of the 28-day study period.
- Change in pulmonary artery systolic pressure [ Time Frame: 28 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00960921
|Institute of Molecular Biology and Medicine|
|Bishkek, Kyrgyzstan, 720040|
|Principal Investigator:||Peter A Robbins, DPhil BM BCh||University of Oxford|