Acute Decompensated Heart FailurePhase 2PreCONDITIONNCT00699712
Study to Assess Hemodynamic Effects, Safety and Tolerability of Chimeric Natriuretic Peptide (CD-NP) in Patients With Stabilized Acute Heart Failure (AHF)
A Phase 2 study testing CD-NP (Chimeric natriuretic peptide) in people with Acute Decompensated Heart Failure, run by Nile Therapeutics at 1 site in Russia.
Trial summary
To access the efficacy of intravenous (IV) administration of CD-NP on changes in cardiac output and wedge pressure in patients with stabilized acute heart failure 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?
- CD-NP (Chimeric natriuretic peptide)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteRussia
- Study dates
- Jun 2008to Dec 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalization for AHF
- In need of hemodynamic monitoring
Who cannot join
- Administration of intravenous radiographic contrast agent within 7 days prior to screening or planned IV contrast media administration in the 4 days after screening or acute contrast-induced nephropathy at the time of screening
- Current or planned treatment with any IV therapies, including diuretics, vasodilators (including nesiritide), vasopressin antagonists, positive inotropic agents and vasopressors, or mechanical support
- Current or planned ultrafiltration, hemofiltration, or dialysis within 7 days of screening
- Significant pulmonary disease
- Known valvular heart disease
- Any organ transplant recipient or patient currently listed for transplant or admitted for any transplantation.
Show all 15Show fewer
- Major surgery within 30 days of screening
- Other major disability or disease with expected survival less than 6 months.
- Major neurologic event, including cerebrovascular events, in the 60 days prior to screening
- Clinical diagnosis of acute coronary syndrome within 45 days of screening
- Troponin T ≥ 3 times the upper limit of normal at screening
- Significant arrhythmias
- Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy
- Liver function abnormality
- Administration of an investigational drug or implantation of investigational device, or participation in another trial, within 30 days prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-Center, Open Label, Dose Escalating, Sequential Group Study to Assess the Hemodynamic Effects, Safety and Tolerability of CD-NP in Patients With Stabilized Acute Heart Failure (AHF)
To access the efficacy of intravenous (IV) administration of CD-NP on changes in cardiac output and wedge pressure in patients with stabilized acute heart failure
- Conditions
- Acute Decompensated Heart Failure
- Being tested
- CD-NP (Chimeric natriuretic peptide)
- Keywords
- ADHF, AHF, HF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD-NP (Chimeric natriuretic peptide)Drug
Infusion of CDNP at two of four doses
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Open-label regimen of doses 1 and 2 of CDNP Receives: Drug: CD-NP (Chimeric natriuretic peptide) |
| B | Experimental | Open-label regimen of doses 2 and 3 of CDNP Receives: Drug: CD-NP (Chimeric natriuretic peptide) |
| C | Experimental | Open-label regimen of doses 3 and 4 of CDNP Receives: Drug: CD-NP (Chimeric natriuretic peptide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cardiac output and wedge pressure
Measured: 8 hours
Secondary outcomes (3)
Changes in additional hemodynamic measures
Measured: 8 hours
Diuresis and natriuresis during and after administration of study drug
Measured: 36 hour
Safety of CD-NP
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2008
- Study completionDec 2008
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nile Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Momentum Research, Inc.
- Investigators
- Hsiao Lieu, MD, Study director, Nile Therapeutics Inc.Gad Cotter, MD, Study director, Momentum Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699712
- Sponsor's protocol ID
- NIL-CDNP-CT003
- Acronym
- PreCONDITION
- Status last verified
- Mar 2009
- First submitted
- 10 Jun 2008
- Last updated
- 25 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center, Open Label, Dose Escalating, Sequential Group Study to Assess the Hemodynamic Effects, Safety and Tolerability of CD-NP in Patients With Stabilized Acute Heart Failure (AHF)
- ClinicalTrials.gov ID
- NCT00699712
- Acronym / sponsor ID
- PreCONDITION / NIL-CDNP-CT003
- Conditions
- Acute Decompensated Heart Failure
- Keywords
- ADHF, AHF, HF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nile TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Momentum Research, Inc.
- Study start
- Jun 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 18 Jun 2008 (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.
To access the efficacy of intravenous (IV) administration of CD-NP on changes in cardiac output and wedge pressure in patients with stabilized acute heart failure
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: CD-NP (Chimeric natriuretic peptide)Open-label regimen of doses 1 and 2 of CDNP |
| B | Experimental | Drug: CD-NP (Chimeric natriuretic peptide)Open-label regimen of doses 2 and 3 of CDNP |
| C | Experimental | Drug: CD-NP (Chimeric natriuretic peptide)Open-label regimen of doses 3 and 4 of CDNP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hospitalization for AHF
- In need of hemodynamic monitoring
Key exclusion criteria (15 listed)
- Administration of intravenous radiographic contrast agent within 7 days prior to screening or planned IV contrast media administration in the 4 days after screening or acute contrast-induced nephropathy at the time of screening
- Current or planned treatment with any IV therapies, including diuretics, vasodilators (including nesiritide), vasopressin antagonists, positive inotropic agents and vasopressors, or mechanical support
- Current or planned ultrafiltration, hemofiltration, or dialysis within 7 days of screening
- Significant pulmonary disease
- Known valvular heart disease
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-NP (Chimeric natriuretic peptide)Infusion of CDNP at two of four doses | Drug | A, B, C |
Primary outcome
Changes in cardiac output and wedge pressure
Time frame: 8 hours
3 secondary outcomes
Changes in additional hemodynamic measures
Time frame: 8 hours
Diuresis and natriuresis during and after administration of study drug
Time frame: 36 hour
Safety of CD-NP
Time frame: 30 Days
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 25 Mar 2009.
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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 Inc.
Gad Cotter, MD study director
Momentum Research, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CD-NP (Chimeric natriuretic peptide) in people with Acute Decompensated Heart Failure, run by Nile Therapeutics at 1 site in Russia.
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 2 inclusion and 15 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 25 Mar 2009. 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 Russia. 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 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?
Changes in cardiac output and wedge pressure (time frame: 8 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 25 Mar 2009.