Carbon Monoxide Therapy for Severe Pulmonary Arterial Hypertension

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Hypertension, Pulmonary

In brief

The purpose of this study is to examine the potential of carbon monoxide (CO) to decrease elevated blood pressure in the pulmonary artery. This symptom is seen in patients with pulmonary arterial hypertension, a rare disease that causes fatigue, dizziness, and shortness of breath because the blood vessels that supply the lungs narrow, forcing the heart to work harder to push blood through. Previous studies in the laboratory have shown that carbon monoxide has promise in treating these symptoms. Subjects in this study are being asked to undergo a new type of treatment to improve pulmonary arterial hypertension by breathing CO gas. CO is a colorless, tasteless, odorless gas usually found in car exhaust or cigarette smoke. It is administered with a continuous flow of air. Subjects will undergo a screening process during which it will be determined if they are eligible for the study. After the screening process, if subjects meet eligibility criteria for the study, they will begin carbon monoxide treatment through a cushioned mask that is placed over the nose and mouth. This treatment will last for sixteen weeks.

Key facts

Study ID: NCT01523548
Run by: University of Illinois at Chicago
People needed: 0
Starts: 2012-07-01
Expected to finish: 2018-12-01
Last updated by the study team: 2017-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

male and female ≥ 18 years old , with Pulmonary Arterial Hypertension
Right heart catheterization diagnosis of PAH:
Mean Pulmonary Artery Pressure (mPAP)> 25 mmHg at rest
Pulmonary Capillary Occlusion Pressure (PCOP) or Left Ventricular End Diastolic Pressure (LVEDP) < 15 mmHg
Pulmonary Vascular Resistance (PVR) > 3 mmHg/L/min
Must be Class 1.1, 1.2, or 1.3 PAH (see Appendix A)
Echocardiographic evidence of Right Ventricular Dysfunction
On standard and stable PAH therapy (no dose changes in the 4 weeks prior to starting the study medication) including:
A Prostacyclin (IV epoprostenol, IV or subcutaneous remodulin, inhaled iloprost or remodulin) unless willing or unable to tolerate therapy AND
Phosphodiesterase type 5 inhibitor OR
Endothelin Receptor Antagonist OR
Any combination of a-c
NYHA class III or IV despite 3 months of stable therapy as outlined above
6 minute walk distance ≤ 380m
Negative serum pregnancy test
Female of childbearing age either surgically sterilized or using acceptable method of contraception. Acceptable methods of contraception include oral contraceptives, IUD, or other barrier methods of contraception.

You may not qualify if…

History of malignancy in 2 years prior to enrollment
Baseline cytopenia's:
White blood cell count ≤ 3,000 i. Absolute Neutrophil Count (ANC) less than 1500 cells/mm3
Hemoglobin ≤ 7
Platelet ≤ 100,000
Baseline Liver Disease:
ALT/AST, ALk phos > 2.5x ULN, INR > 1.5
Bilirubin > 1.5 x ULN
Coronary artery disease
Any cause of pulmonary hypertension other than class 1.1, 1.2, or 1.3 PAH.
Baseline Renal Disease: Cr ≥ 2
Active Smoker
Hypoxemia with SaO2 < 95% on oxygen 2 L/min
Baseline COHb > 2%
Pregnancy or lactation
Inability to attend scheduled clinic visits
Previous lung transplant
Naive to available standard PAH therapy
Pulmonary Capillary Occlusion Pressure (PCOP) or LEft Ventricular End Diastolic Pressure (LVEDP)< 15 mmHg
Concomitant enrollment in another investigational treatment protocol for PAH or taking any off label drug therapy for PAH
Recent enrollment in or plans to enroll in Pulmonary Rehabilitation during the study period
Any condition that in the opinion of the investigator would prevent completion of study procedures

Where it is running

University of Illinois at Chicago Medical Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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