Pulmonary HypertensionPhase 4NCT00205426
Natrecor for Pulmonary Hypertension in Lung Transplants
A Phase 4 study testing Natrecor in people with Pulmonary Hypertension, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study seeks to demonstrate that Natrecor® (nesiritide) is safe and effective and has a favorable hemodynamic profile in lung transplant recipients that will allow for the avoidance of inhaled nitric oxide (iNO) use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Natrecor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to May 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Single or double lung transplant or heart/lung transplant recipient
- Planned use of Natrecor
- Pulmonary artery (PA) systolic pressures > 35
Who cannot join
- Previous lung transplant
- Use of Prolastin after pneumonectomy
- Mean arterial pressure of < 55
- Known allergy or sensitivity to nesiritide
- Females of childbearing potential with a positive pregnancy test or women who are breast feeding
- Use of nesiritide, for any reason, within 30 days prior to transplant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
About this study
Official title: Natrecor® (Nesiritide) as a Nitric Oxide Sparing Agent in Patients Undergoing Lung Transplantation
This study seeks to demonstrate that Natrecor® (nesiritide) is safe and effective and has a favorable hemodynamic profile in lung transplant recipients that will allow for the avoidance of inhaled nitric oxide (iNO) use. It is estimated that the use of nesiritide will decrease the otherwise historically mandated use of iNO by 50%, as compared to the necessity of iNO use by matched historical controls.
Read the detailed description
A condition called ischemic reperfusion injury (IRI) occurs in all lung transplants. The amount of reperfusion injury varies from person to person. IRI occurs when the blood supply to tissue (in this case, transplanted lung(s)) is decreased and then is restored. IRI can cause a decrease in function in a newly transplanted lung. When this occurs, or when people have pulmonary hypertension (high blood pressure in your lungs), doctors use Nitric Oxide to improve the pressure and blood supply to the transplanted lung. Nitric Oxide (NO) is given by inhalation while patients are on a ventilator (breathing machine). Because NO must be given by a ventilator and because patients on ventilators must be in an intensive care unit, the cost of treating people with NO is very high. NO can also cause rebound pulmonary hypertension (high blood pressure in the lungs that reoccurs) when it is stopped. Because of these reasons, doctors are looking for other treatments for IRI and pulmonary hypertension. A drug called Natrecor has been shown to reduce pulmonary pressures in heart transplant patients. Doctors believe it may be helpful to lung transplant patients as well.
- Conditions
- Pulmonary Hypertension
- Being tested
- Natrecor
- Keywords
- Pulmonary hypertension in lung transplant recipients
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NatrecorDrug
Also called nesiritide
Natrecor will be initiated as a bolus dose of 2 mcg/kg followed by a continuous infusion via infusion pump after induction of anesthesia but prior to incision. Natrecor infusion will be started at the recommended rate of 0.01mcg/kg/min. This dose may be adjusted by the investigator(s) only based on hemodynamic monitoring and pulmonary parameters. Study drug will be infused for a minimum of 24 hours and a maximum of 96 hours.
| Study group | Role | What they receive |
|---|---|---|
| Natrecor infusion | Experimental | Nesiritide Receives: Drug: Natrecor |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and efficacy of Natrecor® in reducing nitric oxide used perioperatively in patients undergoing single or double lung transplantation who have or are at risk for developing pulmonary hypertension
Secondary outcomes (10)
To compare total cost-effective evaluation between patients receiving Natrecor and those who received iNO
To compare length of stay in the Intensive Care Unit (ICU)
To compare renal function as defined by peak serum creatinine and calculated creatinine clearance during the first 72 hours post-transplant
To compare necessity of CPB between Natrecor® versus nitric oxide
To compare hemodynamic parameters
To compare length of stay (total)
To compare time to dry weight
To compare duration of mechanical ventilation
To compare pulmonary parameters
To compare IRI via chest x-ray and PAO2/FIO2 ratio
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Love, MD, Principal investigator, University of Wisconsin Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00205426
- Sponsor's protocol ID
- H-2005-0185
- Status last verified
- Oct 2015
- First submitted
- 13 Sep 2005
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natrecor® (Nesiritide) as a Nitric Oxide Sparing Agent in Patients Undergoing Lung Transplantation
- ClinicalTrials.gov ID
- NCT00205426
- Acronym / sponsor ID
- H-2005-0185
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary hypertension in lung transplant recipients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to demonstrate that Natrecor® (nesiritide) is safe and effective and has a favorable hemodynamic profile in lung transplant recipients that will allow for the avoidance of inhaled nitric oxide (iNO) use. It is estimated that the use of nesiritide will decrease the otherwise historically mandated use of iNO by 50%, as compared to the necessity of iNO use by matched historical controls.
Detailed description
A condition called ischemic reperfusion injury (IRI) occurs in all lung transplants. The amount of reperfusion injury varies from person to person. IRI occurs when the blood supply to tissue (in this case, transplanted lung(s)) is decreased and then is restored. IRI can cause a decrease in function in a newly transplanted lung. When this occurs, or when people have pulmonary hypertension (high blood pressure in your lungs), doctors use Nitric Oxide to improve the pressure and blood supply to the transplanted lung. Nitric Oxide (NO) is given by inhalation while patients are on a ventilator (breathing machine). Because NO must be given by a ventilator and because patients on ventilators must be in an intensive care unit, the cost of treating people with NO is very high. NO can also cause rebound pulmonary hypertension (high blood pressure in the lungs that reoccurs) when it is stopped. Because of these reasons, doctors are looking for other treatments for IRI and pulmonary hypertension. A drug called Natrecor has been shown to reduce pulmonary pressures in heart transplant patients. Doctors believe it may be helpful to lung transplant patients as well.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Natrecor infusion | Experimental | Drug: NatrecorNesiritide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Single or double lung transplant or heart/lung transplant recipient
- Planned use of Natrecor
- Pulmonary artery (PA) systolic pressures > 35
Key exclusion criteria (6 listed)
- Previous lung transplant
- Use of Prolastin after pneumonectomy
- Mean arterial pressure of < 55
- Known allergy or sensitivity to nesiritide
- Females of childbearing potential with a positive pregnancy test or women who are breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NatrecorAlso: nesiritideNatrecor will be initiated as a bolus dose of 2 mcg/kg followed by a continuous infusion via infusion pump after induction of anesthesia but prior to incision. Natrecor infusion will be started at the recommended rate of 0.01mcg/kg/min. This dose may be adjusted by the investigator(s) only based on hemodynamic monitoring and pulmonary parameters. Study drug will be infused for a minimum of 24 hours and a maximum of 96 hours. | Drug | Natrecor infusion |
Primary outcome
To evaluate the safety and efficacy of Natrecor® in reducing nitric oxide used perioperatively in patients undergoing single or double lung transplantation who have or are at risk for developing pulmonary hypertension
10 secondary outcomes
To compare total cost-effective evaluation between patients receiving Natrecor and those who received iNO
To compare length of stay in the Intensive Care Unit (ICU)
To compare renal function as defined by peak serum creatinine and calculated creatinine clearance during the first 72 hours post-transplant
To compare necessity of CPB between Natrecor® versus nitric oxide
To compare hemodynamic parameters
To compare length of stay (total)
To compare time to dry weight
To compare duration of mechanical ventilation
To compare pulmonary parameters
To compare IRI via chest x-ray and PAO2/FIO2 ratio
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Love, MD principal investigator
University of Wisconsin Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Natrecor in people with Pulmonary Hypertension, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and efficacy of Natrecor® in reducing nitric oxide used perioperatively in patients undergoing single or double lung transplantation who have or are at risk for developing pulmonary hypertension. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015; AzTrials last refreshed its copy on 7 Nov 2026.