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A clinical trial to evaluate iron preparation effect for the pulmonary hypertension secondary in chronic respiratory disease patients

A clinical trial to evaluate iron preparation effect for the pulmonary hypertension secondary in chronic respiratory disease patients - Secondary PH-Fe study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000007840
Enrollment
41
Registered
2012-04-26
Start date
2011-12-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic respiratory failure patients with pulmonary arterial hypertension

Interventions

infusion by saccharatedferric oxide

Sponsors

Osaka City General Hospital Department of Respiratory Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Chronic respiratory failure patients 2.Less than Hb 16mg/dl 3.Lower than ferritin level 500ng/ml 4.TR -PG level is more than 32torr in heart ultrasonography findings 5.Age is 60 years old or older 6.Patients receive enough explanation about this study, and patients who provide their written informed consent to participate in this study.

Exclusion criteria

Exclusion criteria: 1.Patient's fever is 38 degrees or more within one week before screening test 2.Patients complicated with active tuberculosis and atypical mycobacterial disease 3.Patients with active respiratory tract infection in chest Xp or clinical examination 4.Patients with active heart failure with the hemostatic findings in chest Xp **But, we make it possible to conduct a screening test after hemostatic findings disappeared in case that recognized hemostatic findings in chest X-rays. 5.Patients with pneumothorax in chest Xp 6.Patients with pleural effusion that drainage needs 7.Patients with history of hypersensitivity with iron preparation formulation 8.Patients who are complicated with apparent hepatic cirrhosis or active hepatitis 9.Patients with history of paroxysmal nocturnal hemoglobinemia 10.Patients with apparent renal failure 11.The patients in acknowledgment of exacerbation with existing illness within one month from screening test 12.A pregnant woman or the patients with the possibility to become pregnant and nursing patients 13.In addition, the patients whom doctor attending judged to be inadequate as a study candidate

Design outcomes

Primary

MeasureTime frame
TR-PG level by the heart ultrasonography

Secondary

MeasureTime frame
PaO2 level, reticulocyte count, NT-pro BNP level, hematocrit, mean concentration hematocrit (MCH), mean corpuscular hemoglobin concentration (MCHC)

Countries

Japan

Contacts

Public ContactMitsuhiro Sumitani

Osaka City Gerenal Hospital Respiratory Medicine

sumytany@nifty.com06-6929-1221

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026