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

NCT00960921 | Withdrawn Phase 2

• 1 other identifier: Oxford-Kyrgyzstan-2009
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension, Pulmonary

Keywords

Pulmonary artery pressure; Hypoxia; Iron; Hypoxia-inducible factor; High altitude

Outcome Measures

Primary Outcomes (1)

• Change in pulmonary artery systolic pressure

  28 days

Study Arms (2)

Iron group

EXPERIMENTAL

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

Saline group

PLACEBO COMPARATOR

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

Interventions

Iron sucrose DRUG

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.

Also known as: Venofer (iron sucrose)

Iron group

Normal saline DRUG

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.

Saline group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Oxford: lead
• National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov: collaborator

Study Sites (1)

Institute of Molecular Biology and Medicine

Bishkek, 720040, Kyrgyzstan

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Hypoxia; Altitude Sickness

Interventions

Ferric Oxide, Saccharated; Saline Solution

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Peter A Robbins, DPhil BM BCh

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2009
• First Posted: August 18, 2009
• Last Updated: May 15, 2017

Record last verified: 2017-05

Locations

KY (1)