Status:
COMPLETED
Nitric Oxide, GeNO Nitrosyl Delivery System
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary aim of the study is to evaluate the safety, tolerability and device performance of the GeNO nitrosyl delivery system during RHC. Secondary considerations are to confirm that inhaled NO gen...
Detailed Description
Investigational product will be administered by qualified study staff in accordance with the procedures described in the protocol and in accordance with the detailed set of instructions supplied with ...
Eligibility Criteria
Inclusion
- An Institutional Review board (IRB) approved informed consent is signed, dated and timed prior to any study-related activities.
- Male or female \> 18 years of age.
- Being evaluated for OHT or LVAD implantation and scheduled to undergo right heart catheterization to assess pulmonary vasoreactivity.
- Have a confirmed diagnosis of heart failure, (NYHA Class III or IV)
- Participant has the ability to understand the requirements of the study and a willingness to comply with all study procedures.
- Females of childbearing potential with a negative urine pregnancy test, or a documented surgical sterilization, or is post-menopausal prior to administration of investigational product. Females of childbearing potential must be practicing adequate birth control to be eligible. It is the Investigator's responsibility to determine whether the Participant has adequate birth control for study participation.
- Confirmed pulmonary arterial hypertension at time of RHC:
- PAPm \> 25mmHg at rest and PVR \> 3 Wood units
Exclusion
- Be receiving an investigational drug, have in place an investigational device, or have participated in an investigational drug study within the past 30 days.
- Have had an atrial septostomy.
- Have anemia (hemoglobin \<10 g/dL), active infection or any other ongoing condition that would interfere with the interpretation of study assessments.
- Have any serious or life-threatening disease other than conditions (e.g. malignancy requiring aggressive chemotherapy, etc.).
- Have unstable psychiatric status or be mentally incapable of understanding the objectives, nature or consequences of the trial, or any condition, which in the investigator's opinion would constitute an unacceptable risk to the participant's safety.
- Participant is pregnant or lactating
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01165047
Start Date
September 1 2010
End Date
September 1 2011
Last Update
October 3 2024
Active Locations (1)
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1
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215