Heart FailurePhase 4NCT00083772
Use of Nesiritide in the Management of Acute Diastolic Heart Failure
A Phase 4 study testing Nesiritide in people with Heart Failure and Cardiovascular Disease, run by M.D. Anderson Cancer Center.
Trial summary
Primary objective is to assess the effect of nesiritide in decreasing left ventricular (LV) filling pressure, defined as pulmonary artery capillary wedge pressure (PCWP) in a group of patients admitted with acute diastolic heart failure. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure, Cardiovascular Disease, Acute Heart Failure
- What is being tested?
- Nesiritide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- 17 May 2004to 24 Apr 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
- Age 18 to 85 years old
- Admitted with acute heart failure determined by: symptoms of fatigue; shortness of breath; edema; physical evidence of volume overload; and/or pulmonary edema by CXR
- LVEF > or = 40% on recent (< or = 1 month) echo or MUGA
- NYHA class III or IV on admission
- Baseline systolic blood pressure > 90 mm Hg
- Baseline BNP level > 100 pg/ml
- Able to sign informed consent and return for follow-up assessments
Who cannot join
- Patients with clinically significant hypotension (defined as a systolic blood pressure (SBP) <90 mm Hg)
- Active infection/sepsis as defined by fever > 101.5 F, currently on IV antibiotics
- Creatinine greater than 3.0 mg/dl
- LV ejection fraction < 40% (must be done within the last 30 days prior to signing consent)
- Significant valvular disease or constrictive cardiomyopathy
- Severe Thrombocytopenia (as defined by platelets less than 20,000) or INR > 1.6
Show all 9Show fewer
- Hypersensitivity to nesiritide or any of its components.
- Pulmonary capillary wedge pressure (PCWP) <16 mmHg
- If patient is of child-bearing age, a pregnancy test will be performed, and the patient is excluded if pregnancy test is positive.
About this study
Official title: The Use of Nesiritide in the Management of Acute Diastolic Heart Failure
Primary objective is to assess the effect of nesiritide in decreasing left ventricular (LV) filling pressure, defined as pulmonary artery capillary wedge pressure (PCWP) in a group of patients admitted with acute diastolic heart failure.
Secondary objectives include: improvement in symptoms, exercise tolerance, improvement in Doppler diastolic filling parameters in patients with diastolic heart failure.
Read the detailed description
Patients with diastolic heart failure often have high pressure in their heart and lungs and many symptoms such as shortness of breath, low energy, fluid retention, and fatigue. Decreasing the pressure in the heart and lungs may help these patients feel better. The drug nesiritide was designed to help treat heart failure. It has also been shown to help decrease the pressure in the lungs.
Before treatment starts, you will be asked questions about your medical history and about any medications you are currently taking. You will have a complete physical exam. You will have an electrocardiogram (ECG - a test that measures the electrical activity of the heart) and routine blood tests (about 2 teaspoons). You will have an ultrasound on your heart called an echocardiogram to measure your heart function and the pressures in your lungs. Your ability to breathe will be evaluated. With the aid of the research nurse, you will have a 6-minute walk test. 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 should take no more than 10 minutes to complete.
In order to measure the pressure in your heart and 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 even 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. After the pressures are measured, you will receive treatment with nesiritide during the right heart catheterization procedure.
Nesiritide will be given as a continuous infusion (for 48 hours) by vein. The pressures in your heart and lungs will be measured again at 15, 30, then 60 minutes after you begin to receive nesiritide. The tubes will then be removed from your heart. 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 1 hour. You will have an ultrasound of your heart performed immediately before and after the right heart catheterization.
Within 15 minutes of the end of the procedure the echocardiogram, the 6-minute walk test, and the questionnaire about your symptoms will be repeated and your breathing will be re-evaluated.
The nesiritide infusion will remain going through a vein in your arm for the next 48 hours. During this infusion you will remain in the hospital on telemetry floor so that researchers can monitor your blood pressure and watch for irregular heartbeat. After you have received this drug for 48 hours, the drug will be stopped. Within 24 hours after stopping treatment, an echocardiogram and a 6-minute walk test will be performed. You will also answer questions about your breathing and your quality of life. These should take no more than 15 minutes of your time to complete.
You will be taken off study if your condition gets worse or intolerable side effects occur.
At 2 and 4 weeks after your hospitalization and the right heart procedure, you will have follow-up visits scheduled. At these visits, you will have a complete physical exam, and possibly have blood work done if required by the doctor as part of your routine care. A blood test to check a BNP (B-type natriuretic peptide) level will also be performed . This is a special blood test to give researchers information about your heart and how much extra fluid you may be carrying with you because of your heart disease. Only 1 teaspoon of blood is needed for this test although up to 3 teaspoons of blood may need to be drawn depending of what blood tests your doctor orders at the follow-up visits.
This is an investigational study. Nesiritide is FDA approved and is commercially available for the treatment of heart failure. However, the use of nesiritide for diastolic heart failure is under research. About 20 patients will take part in this study. All will be enrolled at UTMDACC.
- Conditions
- Heart Failure, Cardiovascular Disease, Acute Heart Failure, Diastolic Heart Failure, Congestive Heart Failure, Heart Disease
- Being tested
- Nesiritide
- Keywords
- Heart failure, Diastolic heart failure, Congestive heart failure, Nesiritide, Natrecor, Left ventricular (LV) diastolic function, Fatigue, Shortness of breath, Edema, Heart disease
- Medical subject headings
- Heart Failure, Cardiovascular Diseases, Heart Failure, Diastolic, Heart Diseases, Fatigue, Dyspnea, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NesiritideDrug
Also called Natrecor
Initial dose by vein of 2 mcg/kg then infusion by vein of 0.01 mcg/kg/min continuously for 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Nesiritide Receives: Drug: Nesiritide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of nesiritide in improving symptoms, including pressure in heart and lungs, related to diastolic heart failure (condition where heart muscle is stiff and not able to relax completely, causing the pressures in heart to increase).
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2004 (estimated)
- Study start17 May 2004
- Primary completion24 Apr 2006
- Study completion24 Apr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Bernard Durand, MD, Study chair, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00083772
- Sponsor's protocol ID
- 2003-0782
- Status last verified
- Nov 2018
- First submitted
- 2 Jun 2004
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Krishnaswamy P, Lubien E, Clopton P, Koon J, Kazanegra R, Wanner E, Gardetto N, Garcia A, DeMaria A, Maisel AS. Utility of B-natriuretic peptide levels in identifying patients with left ventricular systolic or diastolic dysfunction. Am J Med. 2001 Sep;111(4):274-9. doi: 10.1016/s0002-9343(01)00841-5.
PubMed 11566457Cheng V, Kazanagra R, Garcia A, Lenert L, Krishnaswamy P, Gardetto N, Clopton P, Maisel A. A rapid bedside test for B-type peptide predicts treatment outcomes in patients admitted for decompensated heart failure: a pilot study. J Am Coll Cardiol. 2001 Feb;37(2):386-91. doi: 10.1016/s0735-1097(00)01157-8.
PubMed 11216951Zile MR, Gaasch WH, Carroll JD, Feldman MD, Aurigemma GP, Schaer GL, Ghali JK, Liebson PR. Heart failure with a normal ejection fraction: is measurement of diastolic function necessary to make the diagnosis of diastolic heart failure? Circulation. 2001 Aug 14;104(7):779-82. doi: 10.1161/hc3201.094226.
PubMed 11502702Mills RM, Hobbs RE, Young JB. "BNP" for heart failure: role of nesiritide in cardiovascular therapeutics. Congest Heart Fail. 2002 Sep-Oct;8(5):270-3. doi: 10.1111/j.1527-5299.2002.01154.x.
PubMed 12368590Publication Committee for the VMAC Investigators (Vasodilatation in the Management of Acute CHF). Intravenous nesiritide vs nitroglycerin for treatment of decompensated congestive heart failure: a randomized controlled trial. JAMA. 2002 Mar 27;287(12):1531-40. doi: 10.1001/jama.287.12.1531.
PubMed 11911755
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
- The Use of Nesiritide in the Management of Acute Diastolic Heart Failure
- ClinicalTrials.gov ID
- NCT00083772
- Acronym / sponsor ID
- 2003-0782
- Conditions
- Heart Failure, Cardiovascular Disease, Acute Heart Failure, Diastolic Heart Failure, Congestive Heart Failure, Heart Disease
- Keywords
- Heart failure, Diastolic heart failure, Congestive heart failure, Nesiritide, Natrecor, Left ventricular (LV) diastolic function, Fatigue, Shortness of breath
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 9 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 17 May 2004 (actual)
- Primary completion
- 24 Apr 2006 (actual)
- Study completion
- 24 Apr 2006 (actual)
- First posted
- 3 Jun 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.
Primary objective is to assess the effect of nesiritide in decreasing left ventricular (LV) filling pressure, defined as pulmonary artery capillary wedge pressure (PCWP) in a group of patients admitted with acute diastolic heart failure.
Secondary objectives include: improvement in symptoms, exercise tolerance, improvement in Doppler diastolic filling parameters in patients with diastolic heart failure.
Detailed description
Patients with diastolic heart failure often have high pressure in their heart and lungs and many symptoms such as shortness of breath, low energy, fluid retention, and fatigue. Decreasing the pressure in the heart and lungs may help these patients feel better. The drug nesiritide was designed to help treat heart failure. It has also been shown to help decrease the pressure in the lungs.
Before treatment starts, you will be asked questions about your medical history and about any medications you are currently taking. You will have a complete physical exam. You will have an electrocardiogram (ECG - a test that measures the electrical activity of the heart) and routine blood tests (about 2 teaspoons). You will have an ultrasound on your heart called an echocardiogram to measure your heart function and the pressures in your lungs. Your ability to breathe will be evaluated. With the aid of the research nurse, you will have a 6-minute walk test. 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 should take no more than 10 minutes to complete.
In order to measure the pressure in your heart and 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 even 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. After the pressures are measured, you will receive treatment with nesiritide during the right heart catheterization procedure.
Nesiritide will be given as a continuous infusion (for 48 hours) by vein. The pressures in your heart and lungs will be measured again at 15, 30, then 60 minutes after you begin to receive nesiritide. The tubes will then be removed from your heart. 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 1 hour. You will have an ultrasound of your heart performed immediately before and after the right heart catheterization.
Within 15 minutes of the end of the procedure the echocardiogram, the 6-minute walk test, and the questionnaire about your symptoms will be repeated and your breathing will be re-evaluated.
The nesiritide infusion will remain going through a vein in your arm for the next 48 hours. During this infusion you will remain in the hospital on telemetry floor so that researchers can monitor your blood pressure and watch for irregular heartbeat. After you have received this drug for 48 hours, the drug will be stopped. Within 24 hours after stopping treatment, an echocardiogram and a 6-minute walk test will be performed. You will also answer questions about your breathing and your quality of life. These should take no more than 15 minutes of your time to complete.
You will be taken off study if your condition gets worse or intolerable side effects occur.
At 2 and 4 weeks after your hospitalization and the right heart procedure, you will have follow-up visits scheduled. At these visits, you will have a complete physical exam, and possibly have blood work done if required by the doctor as part of your routine care. A blood test to check a BNP (B-type natriuretic peptide) level will also be performed . This is a special blood test to give researchers information about your heart and how much extra fluid you may be carrying with you because of your heart disease. Only 1 teaspoon of blood is needed for this test although up to 3 teaspoons of blood may need to be drawn depending of what blood tests your doctor orders at the follow-up visits.
This is an investigational study. Nesiritide is FDA approved and is commercially available for the treatment of heart failure. However, the use of nesiritide for diastolic heart failure is under research. About 20 patients will take part in this study. All will be enrolled at UTMDACC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: NesiritideNesiritide |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 85 years old
- Admitted with acute heart failure determined by: symptoms of fatigue; shortness of breath; edema; physical evidence of volume overload; and/or pulmonary edema by CXR
- LVEF > or = 40% on recent (< or = 1 month) echo or MUGA
- NYHA class III or IV on admission
- Baseline systolic blood pressure > 90 mm Hg
Key exclusion criteria (9 listed)
- Patients with clinically significant hypotension (defined as a systolic blood pressure (SBP) <90 mm Hg)
- Active infection/sepsis as defined by fever > 101.5 F, currently on IV antibiotics
- Creatinine greater than 3.0 mg/dl
- LV ejection fraction < 40% (must be done within the last 30 days prior to signing consent)
- Significant valvular disease or constrictive cardiomyopathy
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 |
|---|---|---|
| NesiritideAlso: NatrecorInitial dose by vein of 2 mcg/kg then infusion by vein of 0.01 mcg/kg/min continuously for 48 hours. | Drug | 1 |
Primary outcome
Effectiveness of nesiritide in improving symptoms, including pressure in heart and lungs, related to diastolic heart failure (condition where heart muscle is stiff and not able to relax completely, causing the pressures in heart to increase).
Time frame: 2 Years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- Background: PubMed 11566457Krishnaswamy P, Lubien E, Clopton P, Koon J, Kazanegra R, Wanner E, Gardetto N, Garcia A, DeMaria A, Maisel AS. Utility of B-natriuretic peptide levels in identifying patients with left ventricular systolic or diastolic dysfunction. Am J Med. 2001 Sep;111(4):274-9. doi: 10.1016/s0002-9343(01)00841-5.
- Background: PubMed 11216951Cheng V, Kazanagra R, Garcia A, Lenert L, Krishnaswamy P, Gardetto N, Clopton P, Maisel A. A rapid bedside test for B-type peptide predicts treatment outcomes in patients admitted for decompensated heart failure: a pilot study. J Am Coll Cardiol. 2001 Feb;37(2):386-91. doi: 10.1016/s0735-1097(00)01157-8.
- Background: PubMed 11502702Zile MR, Gaasch WH, Carroll JD, Feldman MD, Aurigemma GP, Schaer GL, Ghali JK, Liebson PR. Heart failure with a normal ejection fraction: is measurement of diastolic function necessary to make the diagnosis of diastolic heart failure? Circulation. 2001 Aug 14;104(7):779-82. doi: 10.1161/hc3201.094226.
- Background: PubMed 12368590Mills RM, Hobbs RE, Young JB. "BNP" for heart failure: role of nesiritide in cardiovascular therapeutics. Congest Heart Fail. 2002 Sep-Oct;8(5):270-3. doi: 10.1111/j.1527-5299.2002.01154.x.
- Background: PubMed 11911755Publication Committee for the VMAC Investigators (Vasodilatation in the Management of Acute CHF). Intravenous nesiritide vs nitroglycerin for treatment of decompensated congestive heart failure: a randomized controlled trial. JAMA. 2002 Mar 27;287(12):1531-40. doi: 10.1001/jama.287.12.1531.
- 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.
Jean-Bernard Durand, MD study chair
UT MD Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nesiritide in people with Heart Failure and Cardiovascular Disease, run by M.D. Anderson Cancer Center.
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 7 inclusion and 9 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.
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. 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?
Effectiveness of nesiritide in improving symptoms, including pressure in heart and lungs, related to diastolic heart failure (condition where heart muscle is stiff and not able to relax completely, causing the pressures in heart to increase). (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00083772, which also lists 5 linked publications.
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.