Congestive Heart FailurePhase 1NCT00557661
Safety Study of CD-NP in Heart Failure
A Phase 1 study testing CD-NP in people with Congestive Heart Failure, run by Nile Therapeutics.
Trial summary
An open-label study designed to determine the safety, tolerability and pharmacodynamics of CD-NP infusions in heart failure patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- CD-NP
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Dec 2008
- Phase
- Phase 1
- 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
- Male or female ≥18 years of age diagnosed with NYHA class III or IV heart failure in the last six months
- Female patients must be post-menopausal or surgically sterile
- Diagnosed heart failure with left ventricular ejection fraction <40% obtained within the prior 6 months with at least one symptoms or signs of volume overload
Who cannot join
- Women who are pregnant, breast-feeding or of child-bearing potential
- Clinically unstable patients
- Major surgical procedures within 30 days of entry
- Febrile temp > 100 degrees F)
- Symptomatic carotid disease, critical carotid stenosis, or stroke within 3 months prior to study entry
- Currently on IV vasoactive support (e.g., heart transplant candidate)
Show all 12Show fewer
- History of unexplained syncope within the past 3 months
- History of organ transplantation
- Comorbidities such as clinically significant cardiac valvular stenosis, aortic valvular disease, restrictive cardiomyopathy, hypertrophic obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension, infiltrative disease, uncorrected congenital heart disease, acute coronary syndrome, restrictive heart failure, or any other condition which, in the opinion of the Investigator, would prevent a patient's participation in the study.
- Participation in a clinical trial of any investigational therapy or device within 30 days prior to randomization.
- Treatment with nesiritide within 14 days prior to dosing.
- Inability to effectively communicate with study personnel.
About this study
Official title: A Multi-Center, Ascending Dose Trial to Assess the Safety, Pharmacokinetics and Pharmacodynamics of CD-NP Infusions in Patients With Congestive Heart Failure
An open-label study designed to determine the safety, tolerability and pharmacodynamics of CD-NP infusions in heart failure patients.
- Conditions
- Congestive Heart Failure
- Being tested
- CD-NP
- Keywords
- Heart failure, CD-NP
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD-NPDrug
24 hr intravenous infusion
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of CD-NP infusions in patients with heart failure
Measured: 28 days
Secondary outcomes (1)
To evaluate the effect of CD-NP infusions on urinary flow rate, urinary sodium and potassium excretion
Measured: 24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2007 (estimated)
- Study startNov 2007
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nile Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Steven Goldsmith, MD, Principal investigator, Hennepin County Medical Center, Minneapolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00557661
- Sponsor's protocol ID
- NIL-CDNP-CT002
- Status last verified
- Mar 2009
- First submitted
- 12 Nov 2007
- Last updated
- 25 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
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
- A Multi-Center, Ascending Dose Trial to Assess the Safety, Pharmacokinetics and Pharmacodynamics of CD-NP Infusions in Patients With Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT00557661
- Acronym / sponsor ID
- NIL-CDNP-CT002
- Conditions
- Congestive Heart Failure
- Keywords
- Heart failure, CD-NP
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nile TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Study completion
- Dec 2008 (actual)
- First posted
- 14 Nov 2007 (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.
An open-label study designed to determine the safety, tolerability and pharmacodynamics of CD-NP infusions in heart failure patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female ≥18 years of age diagnosed with NYHA class III or IV heart failure in the last six months
- Female patients must be post-menopausal or surgically sterile
- Diagnosed heart failure with left ventricular ejection fraction <40% obtained within the prior 6 months with at least one symptoms or signs of volume overload
Key exclusion criteria (12 listed)
- Women who are pregnant, breast-feeding or of child-bearing potential
- Clinically unstable patients
- Major surgical procedures within 30 days of entry
- Febrile temp > 100 degrees F)
- Symptomatic carotid disease, critical carotid stenosis, or stroke within 3 months prior to study entry
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-NP24 hr intravenous infusion | Drug | – |
Primary outcome
To assess the safety and tolerability of CD-NP infusions in patients with heart failure
Time frame: 28 days
1 secondary outcome
To evaluate the effect of CD-NP infusions on urinary flow rate, urinary sodium and potassium excretion
Time frame: 24 hrs
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.
Related trials for Congestive Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
Steven Goldsmith, MD principal investigator
Hennepin County Medical Center, Minneapolis
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CD-NP in people with Congestive Heart Failure, run by Nile Therapeutics.
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 3 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 25 Mar 2009. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To assess the safety and tolerability of CD-NP infusions in patients with heart failure (time frame: 28 days). 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.