Pulmonary HypertensionPhase 4NCT00075179
Natrecor in Pulmonary Hypertension
A Phase 4 study testing Nesiritide (Natrecor) and Right Heart Catheterization in people with Pulmonary Hypertension and Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if the drug nesiritide (Natrecor) is effective in lowering the pressure in your lungs. The primary objective of this study is to establish that Nesiritide (Natrecor) is effective in reducing pulmonary hypertension (PHTN) acutely as measured by a 20% reduction in the… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pulmonary Hypertension, Cancer, Lung Disease
- What is being tested?
- Nesiritide (Natrecor) and Right Heart Catheterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2003to 28 Mar 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18 to 85 years old.
- Evidence of underlying lung disease by history and physical and/or chest x-ray and/or pulmonary function testing (PFT's).
- PHTN documented by Doppler Echocardiography ( Done with in last 30 days)
- Must be able to give an informed consent.
Who cannot join
- Patients with clinically significant hypotension (defined as a systolic blood pressure (SBP) <90).
- Active infection or sepsis as defined by fever and need for IV antibiotics.
- Creatinine greater than 3.0 mg/dl
- Significant valvular disease as a cause for the PHTN.
- Severe Thrombocytopenia (as defined by platelets less than 20,000 or INR > 1.6.
- Left Ventricle Ejection Fraction (LVEF) <40% (must be done with in the last 30 days prior to signing consent).
- Hypersensitivity to nesiritide or any of it's components.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IV, Open Labeled Study to Test the Effectiveness of Nesiritide in Reversing Pulmonary Hypertension in Patients Who Will be Undergoing CardioThoracic Surgery
The goal of this clinical research study is to learn if the drug nesiritide (Natrecor) is effective in lowering the pressure in your lungs.
The primary objective of this study is to establish that Nesiritide (Natrecor) is effective in reducing pulmonary hypertension (PHTN) acutely as measured by a 20% reduction in the mean pulmonary arterial (PA) pressure. The secondary objectives will include: improvement in pulmonary vascular resistance (PVR), patient symptoms, exercise tolerance, frequency of toxicity, and surgeon's willingness to proceed with operation.
Read the detailed description
Patients with high pressure in their lungs often have many symptoms such as, shortness of breath, low energy, and fatigue. Decreasing the pressure in the lungs may help these patients feel better. The drug nesiritide was designed to help treat heart failure, however, it may also help to decrease the pressure in the lungs.
Before treatment, you will be asked questions about your medical history and about any medications you are currently taking. You will have a focused physical exam. You will have an electrocardiogram (ECG - a test that measures the electrical activity of the heart). You will have an ultrasound on your heart called an echocardiogram to measure the pressures in your lungs and your ability to breathe will be evaluated. With the aid of the research nurse, you will have a 6-minute walk test if you are able. You may stop or sit down at any time during the test. This test is being done to evaluate your energy level. You will also be asked to complete a questionnaire about your symptoms. This questionnaire will take no longer than 10 minutes to complete.
In order to measure the pressure in your lungs, you will have a procedure called a "right heart catheterization". This is a procedure that may have been done as part of your standard of care if you were not enrolled in this study. For this procedure, a small tube will be placed in a vein in your neck. A longer tube will be inserted into the first tube and fed through the vein and into your heart. This tube will be used to measure the pressure in your heart and lungs. If the pressure in your lungs is above a certain level, you will receive treatment with nesiritide during the right heart catheterization procedure. Nesiritide will be given by vein over 30 minutes. After treatment, the pressure in your heart and lungs will be measured again. You will be awake during this procedure and lying flat on your back. An anesthetic will be used to numb the area of your neck where the tube is placed. The entire procedure (including treatment) should take no longer than 2 hours. When complete, the tubes will be removed.
Within 15 minutes of the end of the procedure, the 6-minute walk test (if you are able) and the questionnaire about your symptoms will be repeated and your breathing will be reassessed.
You will also have around 2 teaspoons of blood collected for special lab tests. These tests are being done to check for certain molecules in your blood. The blood that is leftover after these tests may be stored in a freezer.
Around 30 days after the procedure, you will have a follow-up visit scheduled or contacted by phone. At this visit, you will have a complete physical exam done by the doctor, and possibly have blood work done if required by the doctor as part of your routine care. There will be no additional blood work done for study purposes.
This is an investigational study. Nesiritide is FDA approved and is commercially available only for the treatment of heart failure. However, the use of nesiritide in this study is experimental. Around 20 patients will be enrolled at M. D. Anderson.
- Conditions
- Pulmonary Hypertension, Cancer, Lung Disease, Cardiothoracic Surgery
- Being tested
- Nesiritide (Natrecor), Right Heart Catheterization
- Keywords
- Pulmonary hypertension, cancer, lung cancer, lung disease, cardiothoracic surgery, Nesiritide, Natrecor, CV Surgery, Lung Tumor
- Medical subject headings
- Hypertension, Pulmonary, Neoplasms, Lung Diseases, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nesiritide (Natrecor)Drug
Given initially as a bolus (2 mcg/kg) and than infused for 30 minutes (0.01 mcg/kg/min) during right heart catheterization.
Right Heart CatheterizationProcedure or surgery
Small tubes placed in neck vein to heart as means of measuring pressure in heart and lungs; treatment with nesiritide delivered during procedure.
| Study group | Role | What they receive |
|---|---|---|
| Nesiritide | Experimental | Nesiritide 0.01 mcg/kg/min by vein over 30 minutes during right heart catheterization procedure. Receives: Drug: Nesiritide (Natrecor); Procedure: Right Heart Catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number Patients with 20% reduction in mean pulmonary arterial (PA) pressure to measure pulmonary hypertension (PHTN)
Measured: Baseline and 15 and 30 minutes after end of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2004 (estimated)
- Study start31 Dec 2003
- Primary completion28 Mar 2006
- Study completion28 Mar 2006
Why it stopped: Low accrual.
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 M.D. Anderson Cancer CenterThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel J. Lenihan, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00075179
- Sponsor's protocol ID
- 2003-0562
- Status last verified
- Nov 2018
- First submitted
- 5 Jan 2004
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV, Open Labeled Study to Test the Effectiveness of Nesiritide in Reversing Pulmonary Hypertension in Patients Who Will be Undergoing CardioThoracic Surgery
- ClinicalTrials.gov ID
- NCT00075179
- Acronym / sponsor ID
- 2003-0562
- Conditions
- Pulmonary Hypertension, Cancer, Lung Disease, Cardiothoracic Surgery
- Keywords
- Pulmonary hypertension, cancer, lung cancer, lung disease, cardiothoracic surgery, Nesiritide, Natrecor, CV Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 31 Dec 2003 (actual)
- Primary completion
- 28 Mar 2006 (actual)
- Study completion
- 28 Mar 2006 (actual)
- First posted
- 6 Jan 2004 (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.
The goal of this clinical research study is to learn if the drug nesiritide (Natrecor) is effective in lowering the pressure in your lungs.
The primary objective of this study is to establish that Nesiritide (Natrecor) is effective in reducing pulmonary hypertension (PHTN) acutely as measured by a 20% reduction in the mean pulmonary arterial (PA) pressure. The secondary objectives will include: improvement in pulmonary vascular resistance (PVR), patient symptoms, exercise tolerance, frequency of toxicity, and surgeon's willingness to proceed with operation.
Detailed description
Patients with high pressure in their lungs often have many symptoms such as, shortness of breath, low energy, and fatigue. Decreasing the pressure in the lungs may help these patients feel better. The drug nesiritide was designed to help treat heart failure, however, it may also help to decrease the pressure in the lungs.
Before treatment, you will be asked questions about your medical history and about any medications you are currently taking. You will have a focused physical exam. You will have an electrocardiogram (ECG - a test that measures the electrical activity of the heart). You will have an ultrasound on your heart called an echocardiogram to measure the pressures in your lungs and your ability to breathe will be evaluated. With the aid of the research nurse, you will have a 6-minute walk test if you are able. You may stop or sit down at any time during the test. This test is being done to evaluate your energy level. You will also be asked to complete a questionnaire about your symptoms. This questionnaire will take no longer than 10 minutes to complete.
In order to measure the pressure in your lungs, you will have a procedure called a "right heart catheterization". This is a procedure that may have been done as part of your standard of care if you were not enrolled in this study. For this procedure, a small tube will be placed in a vein in your neck. A longer tube will be inserted into the first tube and fed through the vein and into your heart. This tube will be used to measure the pressure in your heart and lungs. If the pressure in your lungs is above a certain level, you will receive treatment with nesiritide during the right heart catheterization procedure. Nesiritide will be given by vein over 30 minutes. After treatment, the pressure in your heart and lungs will be measured again. You will be awake during this procedure and lying flat on your back. An anesthetic will be used to numb the area of your neck where the tube is placed. The entire procedure (including treatment) should take no longer than 2 hours. When complete, the tubes will be removed.
Within 15 minutes of the end of the procedure, the 6-minute walk test (if you are able) and the questionnaire about your symptoms will be repeated and your breathing will be reassessed.
You will also have around 2 teaspoons of blood collected for special lab tests. These tests are being done to check for certain molecules in your blood. The blood that is leftover after these tests may be stored in a freezer.
Around 30 days after the procedure, you will have a follow-up visit scheduled or contacted by phone. At this visit, you will have a complete physical exam done by the doctor, and possibly have blood work done if required by the doctor as part of your routine care. There will be no additional blood work done for study purposes.
This is an investigational study. Nesiritide is FDA approved and is commercially available only for the treatment of heart failure. However, the use of nesiritide in this study is experimental. Around 20 patients will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nesiritide | Experimental | Drug: Nesiritide (Natrecor), Procedure: Right Heart CatheterizationNesiritide 0.01 mcg/kg/min by vein over 30 minutes during right heart catheterization procedure. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages 18 to 85 years old.
- Evidence of underlying lung disease by history and physical and/or chest x-ray and/or pulmonary function testing (PFT's).
- PHTN documented by Doppler Echocardiography ( Done with in last 30 days)
- Must be able to give an informed consent.
Key exclusion criteria (7 listed)
- Patients with clinically significant hypotension (defined as a systolic blood pressure (SBP) <90).
- Active infection or sepsis as defined by fever and need for IV antibiotics.
- Creatinine greater than 3.0 mg/dl
- Significant valvular disease as a cause for the PHTN.
- Severe Thrombocytopenia (as defined by platelets less than 20,000 or INR > 1.6.
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 |
|---|---|---|
| Nesiritide (Natrecor)Given initially as a bolus (2 mcg/kg) and than infused for 30 minutes (0.01 mcg/kg/min) during right heart catheterization. | Drug | Nesiritide |
| Right Heart CatheterizationSmall tubes placed in neck vein to heart as means of measuring pressure in heart and lungs; treatment with nesiritide delivered during procedure. | Procedure or surgery | Nesiritide |
Primary outcome
Number Patients with 20% reduction in mean pulmonary arterial (PA) pressure to measure pulmonary hypertension (PHTN)
Time frame: Baseline and 15 and 30 minutes after end of procedure
Results and safety
The study was stopped early (reason given: Low accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- MD Anderson Cancer Center, Department of CardiologyLink provided by the sponsor.
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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.
Daniel J. Lenihan, MD study chair
M.D. Anderson Cancer Center
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 Nesiritide (Natrecor) and Right Heart Catheterization in people with Pulmonary Hypertension and Cancer, run by M.D. Anderson Cancer Center 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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 7 Nov 2018. 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 was stopped early (reason given: Low accrual.). Results are not available in the source record.
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?
Number Patients with 20% reduction in mean pulmonary arterial (PA) pressure to measure pulmonary hypertension (PHTN) (time frame: Baseline and 15 and 30 minutes after end of procedure). 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 7 Nov 2018.