Trial record 10 of 15 for:    "Pulmonary edema of mountaineers"

Study of the Effects of Iron on Lung Blood Pressure at High Altitude

This study has suspended participant recruitment.
(Study currently suspended at recruitment stage.)
Sponsor:
Collaborator:
Institute of Molecular Biology and Medicine, Kyrgyzstan
Information provided by:
University of Oxford
ClinicalTrials.gov Identifier:
NCT00960921
First received: August 17, 2009
Last updated: April 1, 2011
Last verified: September 2009
  Purpose

Body iron levels may be important in determining how the blood pressure in the lungs changes in response to low oxygen levels. At high altitude, where oxygen levels are low, some patients develop elevated lung blood pressure. The investigators hypothesize that, in high altitude residents with elevated lung blood pressure, iron supplementation will cause a reduction in lung blood pressure.


Condition Intervention Phase
Hypertension, Pulmonary
Drug: Iron sucrose
Drug: Normal saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Study of the Effects of Iron Supplementation on High Altitude Pulmonary Hypertension.

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Change in pulmonary artery systolic pressure [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 26
Study Start Date: August 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • High altitude natives, currently resident at high altitude
  • Pulmonary hypertension (mean pulmonary artery pressure > 25 mmHg)
  • Pulmonary artery systolic pressure measurable using Doppler echocardiography

Exclusion Criteria:

  • Clinical evidence or history of major co-morbidity
  • Recent changes to relevant medications, or taking iron/vitamin supplements
  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: NCT00960921

Locations
Kyrgyzstan
Institute of Molecular Biology and Medicine
Bishkek, Kyrgyzstan, 720040
Sponsors and Collaborators
University of Oxford
Institute of Molecular Biology and Medicine, Kyrgyzstan
Investigators
Principal Investigator: Peter A Robbins, DPhil BM BCh University of Oxford
  More Information

No publications provided

Responsible Party: Professor Peter Robbins, Professor of Physiology, University of Oxford
ClinicalTrials.gov Identifier: NCT00960921     History of Changes
Other Study ID Numbers: Oxford-Kyrgyzstan-2009
Study First Received: August 17, 2009
Last Updated: April 1, 2011
Health Authority: United Kingdom: Research Ethics Committee
Kyrgyzstan: Ethics Committee

Keywords provided by University of Oxford:
Pulmonary artery pressure
Hypoxia
Iron
Hypoxia-inducible factor
High altitude

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Altitude Sickness
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Ferric oxide, saccharated
Ferric Compounds
Iron
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 31, 2014