Acute Decompensated Heart FailurePhase 2NCT00839007
Study to Assess the Safety and Efficacy of CD-NP in the Treatment of Patients With Acute Decompensated Heart Failure
A Phase 2 study testing CD-NP in people with Acute Decompensated Heart Failure, run by Nile Therapeutics at 21 sites in 3 countries.
Trial summary
The primary objective of the study is to assess the safety and tolerability of IV administration of CD-NP and the dose relationship of CD-NP on improvement of clinical symptoms and renal function in ADHF patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Decompensated Heart Failure
- What is being tested?
- CD-NP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 21 sitesin 3 countries
- Study dates
- Jun 2009to Jul 2010
- Phase
- Phase 2
- 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
- Hospitalized for acute decompensated heart failure.
- Systolic blood pressure ≥ 115 mmHg and ≤ 200 mmHg, and diastolic blood pressure ≥ 60 mmHg and ≤ 110 mmHg at screening
- Renally compromised.
- Female patients must be post-menopausal or surgically sterile.
Who cannot join
- Acute or suspected acute myocardial infarction (AMI) or troponin levels > 3X the upper limit of normal at the institution's local laboratory
- Cardiogenic shock
- Evidence of uncorrected volume or sodium depletion other clinical condition that would predispose the patient to adverse events
- Clinically significant aortic or mitral valve stenosis
- Temperature >38°C (oral or equivalent), sepsis or active infection requiring IV anti-microbial treatment
- ADHF due to significant arrhythmias
Show all 12Show fewer
- Severe renal failure defined as creatinine clearance < 30 mL/min
- Current or planned ultrafiltration, hemofiltration, or dialysis
- Significant pulmonary disease
- Major neurologic event, including cerebrovascular events in the prior 60 days.
- Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (not including restrictive mitral filling patterns)
- Known hypersensitivity or allergy to natriuretic peptide or its components, nesiritide, other natriuretic peptides or related compounds
Trial locations and contacts
21 sites in 3 countries.
21 sites in 3 countries
United States10 sites
Study site
Chicago, Illinois, 60611
Study site
Detroit, Michigan, 48201
Study site
Houston, Texas, 77030
Study site
Iowa City, Iowa, 52246
Study site
Jacksonville, Florida, 32216
Study site
Los Angeles, California, 90033
Study site
Miami Beach, Florida, 33149
Study site
Minneapolis, Minnesota, 55415
Study site
The Bronx, New York, 10467
Study site
Torrance, California, 90509
Israel6 sites
Study site
Ashkelon, 78278
Study site
Haifa, 31096
Study site
Nazareth, 16100
Study site
Petah Tikva, 49100
Study site
Safed, 13100
Study site
Tel Aviv, 64239
Germany5 sites
Study site
Berlin, 12351
Study site
Berlin, 13353
Study site
Dortmund, 44137
Study site
Neuss, 41464
Study site
Würzberg, 97080
About this study
Official title: A Multi-Center, Single-Blind, Placebo-Controlled Phase 2 Study Assessing the Safety and Efficacy of Intravenous CD-NP in the Treatment of Patients With Acute Decompensated Heart Failure
The primary objective of the study is to assess the safety and tolerability of IV administration of CD-NP and the dose relationship of CD-NP on improvement of clinical symptoms and renal function in ADHF patients.
- Conditions
- Acute Decompensated Heart Failure
- Being tested
- CD-NP
- Keywords
- ADHF, AHF, HF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD-NPDrug
Infusion of CD-NP at one of up to 6 doses or placebo
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Dose 1 of CD-NP Receives: Drug: CD-NP |
| B | Experimental | Dose 2 of CD-NP Receives: Drug: CD-NP |
| C | Experimental | Dose 3 of CD-NP Receives: Drug: CD-NP |
| D | Experimental | Dose 4 of CD-NP Receives: Drug: CD-NP |
| E | Experimental | Dose 5 of CD-NP Receives: Drug: CD-NP |
| F | Experimental | Dose 6 of CD-NP Receives: Drug: CD-NP |
| G | Placebo comparator | Placebo Receives: Drug: CD-NP |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurence of hypotensive events, clinical symptoms, and renal function change with CD-NP infusion.
Measured: Up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nile Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hsiao Lieu, MD, Study director, Nile Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00839007
- Sponsor's protocol ID
- NIL-CDNP-CT005
- Status last verified
- Sep 2010
- First submitted
- 6 Feb 2009
- Last updated
- 17 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Single-Blind, Placebo-Controlled Phase 2 Study Assessing the Safety and Efficacy of Intravenous CD-NP in the Treatment of Patients With Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT00839007
- Acronym / sponsor ID
- NIL-CDNP-CT005
- Conditions
- Acute Decompensated Heart Failure
- Keywords
- ADHF, AHF, HF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Nile TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 9 Feb 2009 (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 primary objective of the study is to assess the safety and tolerability of IV administration of CD-NP and the dose relationship of CD-NP on improvement of clinical symptoms and renal function in ADHF patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: CD-NPDose 1 of CD-NP |
| B | Experimental | Drug: CD-NPDose 2 of CD-NP |
| C | Experimental | Drug: CD-NPDose 3 of CD-NP |
| D | Experimental | Drug: CD-NPDose 4 of CD-NP |
| E | Experimental | Drug: CD-NPDose 5 of CD-NP |
| F | Experimental | Drug: CD-NPDose 6 of CD-NP |
| G | Placebo comparator | Drug: CD-NPPlacebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hospitalized for acute decompensated heart failure.
- Systolic blood pressure ≥ 115 mmHg and ≤ 200 mmHg, and diastolic blood pressure ≥ 60 mmHg and ≤ 110 mmHg at screening
- Renally compromised.
- Female patients must be post-menopausal or surgically sterile.
Key exclusion criteria (12 listed)
- Acute or suspected acute myocardial infarction (AMI) or troponin levels > 3X the upper limit of normal at the institution's local laboratory
- Cardiogenic shock
- Evidence of uncorrected volume or sodium depletion other clinical condition that would predispose the patient to adverse events
- Clinically significant aortic or mitral valve stenosis
- Temperature >38°C (oral or equivalent), sepsis or active infection requiring IV anti-microbial treatment
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 |
|---|---|---|
| CD-NPInfusion of CD-NP at one of up to 6 doses or placebo | Drug | A, B, C, D, E, F, G |
Primary outcome
The occurence of hypotensive events, clinical symptoms, and renal function change with CD-NP infusion.
Time frame: Up to 72 hours
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 17 Sep 2010.
- Sponsor websiteLink provided by the sponsor.
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Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure
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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.
Hsiao Lieu, MD study director
Nile Therapeutics
21 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CD-NP in people with Acute Decompensated Heart Failure, run by Nile Therapeutics at 21 sites in 3 countries.
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 12 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 17 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Israel, Germany. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The occurence of hypotensive events, clinical symptoms, and renal function change with CD-NP infusion. (time frame: Up to 72 hours). 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 17 Sep 2010.