|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 October 2017 |
|
Main ID: |
NCT01165047 |
|
Date of registration:
|
16/07/2010 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Nitric Oxide, GeNO Nitrosyl Delivery System
|
|
Scientific title:
|
An Open Label, Non-Randomized Pilot Study to Evaluate the Safety and Performance of the GeNO Nitrosyl Delivery System in Subjects Being Evaluated for Orthotopic Heart Transplantation (OHT), or Left Ventricular Assist Device (LVAD) Implantation |
|
Date of first enrolment:
|
September 2010 |
|
Target sample size:
|
10 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01165047 |
|
Study type:
|
Interventional |
|
Study design:
|
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Andrew Boyle, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Aurora Health Care |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- 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 Criteria:
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Pulmonary Arterial Hypertension
|
|
Intervention(s)
|
|
Drug: Nitric Oxide
|
|
Primary Outcome(s)
|
|
Number of Participants With Side Effects and/or Adverse Events
[Time Frame: 5 days]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|