Acute Decompensated Heart FailurePhase 4ABC-HFTNCT00842023
Assessment of Biomarkers and Cardiorenal Syndrome in Acute Decompensated Heart Failure With Vasodilator Therapy
A Phase 4 study testing Nesiritide and Nitroglycerin in people with Acute Decompensated Heart Failure, run by Western University of Health Sciences at 1 site in United States.
Trial summary
The purpose of this study is to determine whether Nesiritide is more effective than nitroglycerin in modifying inflammatory and neurohormonal biomarkers without renal toxicity when proper infusion duration is administered. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure
- What is being tested?
- Nesiritide and Nitroglycerin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Feb 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- At least 18 years of age.
- Subject must be able to understand the potential risks and benefits associated with the study.
- Baseline systolic blood pressure ≥ 90 mm Hg at the time of enrollment.
- Clinical symptoms of dyspnea and laboratory admission BNP levels > 500 pg/mL.
- Neither pregnant or breastfeeding at the time of enrollment.
- Authorization of patient's enrollment by patient's medical provider.
Who cannot join
- <18 years of age
- Denies written informed consent
- Pregnant or lactating.
- Baseline systolic BP < 90 mmHg or cardiogenic shock
- No symptoms of congestion or admission BNP < 500 pg/mL
- Known allergy to E.coli-derived products, or any history of anaphylactic reactions to nesiritide.
- Receiving dialysis at the time of enrollment.
- Serum creatinine > 2.5 mg/dL at the time of enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Centinela Hospital Medical Center
Inglewood, California, 90301
About this study
Official title: A Randomized Controlled Trial to Evaluate Renal Function, Inflammatory Mediators, and Neurohormonal Markers in Acutely Decompensated Heart Failure Patients Receiving Nesiritide Compared to Nitroglycerin.
The purpose of this study is to determine whether Nesiritide is more effective than nitroglycerin in modifying inflammatory and neurohormonal biomarkers without renal toxicity when proper infusion duration is administered.
Read the detailed description
No additional details provided
- Conditions
- Acute Decompensated Heart Failure
- Being tested
- Nesiritide, Nitroglycerin
- Keywords
- Natriuretic peptides, BNP, Heart Failure, Nitoglycerin, Biomarkers
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NesiritideDrug
Bolus 2 mcg/kg followed by 0.01 mcg/kg/min
NitroglycerinDrug
5-10 mcg/min titrating per protocol based on blood pressure
| Study group | Role | What they receive |
|---|---|---|
| Nesiritide Infusion | Experimental | Nesiritide: 2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours. Receives: Drug: Nesiritide |
| Nitroglycerin Infusion | Active comparator | Nitroglycerin was initiated at 10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment. Receives: Drug: Nitroglycerin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal Function by Serum Creatinine
Serum creatinine values and changes in serum creatinine
Measured: Baseline, 24 hours, 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
- Study startJul 2006
- Primary completionJul 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Decompensated Heart FailureStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Clinical Pharmacy
- Responsible party
- Principal investigator, Sheryl Chow, Western University of Health Sciences
- Investigators
- Sheryl L. Chow, PharmD, FCCP, BCPS, Principal investigator, Western University of Heatlh Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842023
- Sponsor's protocol ID
- ACCP-26060
- Acronym
- ABC-HFT
- Status last verified
- Aug 2013
- First submitted
- 10 Feb 2009
- Last updated
- 30 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Chow SL, O'Barr SA, Peng J, Chew E, Pak F, Quist R, Patel P, Patterson JH, Heywood JT. Renal function and neurohormonal changes following intravenous infusions of nitroglycerin versus nesiritide in patients with acute decompensated heart failure. J Card Fail. 2011 Mar;17(3):181-7. doi: 10.1016/j.cardfail.2010.10.005. Epub 2010 Dec 3.
PubMed 21362524Chow SL, O'Barr SA, Peng J, Chew E, Pak F, Quist R, Patel P, Patterson JH, Heywood JT. Modulation of novel cardiorenal and inflammatory biomarkers by intravenous nitroglycerin and nesiritide in acute decompensated heart failure: an exploratory study. Circ Heart Fail. 2011 Jul;4(4):450-5. doi: 10.1161/CIRCHEARTFAILURE.110.958066. Epub 2011 May 16.
PubMed 21576282
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate Renal Function, Inflammatory Mediators, and Neurohormonal Markers in Acutely Decompensated Heart Failure Patients Receiving Nesiritide Compared to Nitroglycerin.
- ClinicalTrials.gov ID
- NCT00842023
- Acronym / sponsor ID
- ABC-HFT / ACCP-26060
- Conditions
- Acute Decompensated Heart Failure
- Keywords
- Natriuretic peptides, BNP, Heart Failure, Nitoglycerin, Biomarkers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Western University of Health SciencesUniversity, hospital or other
- Collaborators
- American College of Clinical Pharmacy
- Study start
- Jul 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 12 Feb 2009 (estimated)
- Results
- Posted 30 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Nesiritide is more effective than nitroglycerin in modifying inflammatory and neurohormonal biomarkers without renal toxicity when proper infusion duration is administered.
Detailed description
No additional details provided
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nesiritide Infusion | Experimental | Drug: NesiritideNesiritide: 2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours. |
| Nitroglycerin Infusion | Active comparator | Drug: NitroglycerinNitroglycerin was initiated at 10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least 18 years of age.
- Subject must be able to understand the potential risks and benefits associated with the study.
- Baseline systolic blood pressure ≥ 90 mm Hg at the time of enrollment.
- Clinical symptoms of dyspnea and laboratory admission BNP levels > 500 pg/mL.
- Neither pregnant or breastfeeding at the time of enrollment.
Key exclusion criteria (8 listed)
- <18 years of age
- Denies written informed consent
- Pregnant or lactating.
- Baseline systolic BP < 90 mmHg or cardiogenic shock
- No symptoms of congestion or admission BNP < 500 pg/mL
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 |
|---|---|---|
| NesiritideBolus 2 mcg/kg followed by 0.01 mcg/kg/min | Drug | Nesiritide Infusion |
| Nitroglycerin5-10 mcg/min titrating per protocol based on blood pressure | Drug | Nitroglycerin Infusion |
Primary outcome
Renal Function by Serum Creatinine
Time frame: Baseline, 24 hours, 48 hours
Serum creatinine values and changes in serum creatinine
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21362524Chow SL, O'Barr SA, Peng J, Chew E, Pak F, Quist R, Patel P, Patterson JH, Heywood JT. Renal function and neurohormonal changes following intravenous infusions of nitroglycerin versus nesiritide in patients with acute decompensated heart failure. J Card Fail. 2011 Mar;17(3):181-7. doi: 10.1016/j.cardfail.2010.10.005. Epub 2010 Dec 3.
- Results publication: PubMed 21576282Chow SL, O'Barr SA, Peng J, Chew E, Pak F, Quist R, Patel P, Patterson JH, Heywood JT. Modulation of novel cardiorenal and inflammatory biomarkers by intravenous nitroglycerin and nesiritide in acute decompensated heart failure: an exploratory study. Circ Heart Fail. 2011 Jul;4(4):450-5. doi: 10.1161/CIRCHEARTFAILURE.110.958066. Epub 2011 May 16.
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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.
Sheryl L. Chow, PharmD, FCCP, BCPS principal investigator
Western University of Heatlh Sciences
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 and Nitroglycerin in people with Acute Decompensated Heart Failure, run by Western University of Health Sciences 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 6 inclusion and 8 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 30 Aug 2013. 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?
Yes. Results are posted in the registry (first posted 30 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Renal Function by Serum Creatinine (time frame: Baseline, 24 hours, 48 hours). 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 NCT00842023, which also lists 2 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 30 Aug 2013.