Status:
WITHDRAWN
Carbon Monoxide Therapy for Severe Pulmonary Arterial Hypertension
Lead Sponsor:
University of Illinois at Chicago
Collaborating Sponsors:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Hypertension, Pulmonary
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 hype...
Detailed Description
Pulmonary arterial hypertension (PAH) remains an uncommon debilitating and fatal disease, and is clinically marked by a progressive increase in pulmonary vascular resistance leading to right heart fai...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01523548
Start Date
July 1 2012
End Date
December 1 2018
Last Update
June 9 2017
Active Locations (1)
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1
University of Illinois at Chicago Medical Center
Chicago, Illinois, United States, 60612