Carbon Monoxide Therapy for Severe Pulmonary Arterial Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01523548
• Date of registration: 27/01/2012
• Prospective Registration: Yes
• Primary sponsor: University of Illinois at Chicago
• Public title: Carbon Monoxide Therapy for Severe Pulmonary Arterial Hypertension CO in PAH
• Scientific title: Carbon Monoxide Therapy for Severe Pulmonary Arterial Hypertension
• Date of first enrolment: July 2012
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT01523548
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Roberto F Machado, MD
• Affiliation: University of Illinois at Chicago

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hypertension, Pulmonary

Intervention(s)

Drug: Carbon Monoxide

Primary Outcome(s)

Evidence of a 20% decrease in pulmonary vascular resistance post-therapy when compared to pre-therapy value [Time Frame: At baseline and after 16 weeks]

Secondary Outcome(s)

Effect of 16-weeks CO inhalation on acute pulmonary vasoreactivity [Time Frame: 16 weeks]

Effect of 16-weeks CO inhalation on right ventricular echocardiographic parameters [Time Frame: 16 weeks]

Effect of 16-weeks CO inhalation on Brain Natriuretic Peptide levels [Time Frame: 16 weeks]

Effect of 16-weeks CO inhalation on functional capacity assessed by six-minute walk test [Time Frame: 16 weeks]

Effect of 16-weeks CO inhalation on other pulmonary and systemic hemodynamic parameters [Time Frame: 16 weeks]

Secondary ID(s)

2010-06425

K23HL098454

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Heart, Lung, and Blood Institute (NHLBI)

National Institutes of Health (NIH)