NCT00839007

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_2

Geographic Reach
3 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 9, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

September 17, 2010

Status Verified

September 1, 2010

Enrollment Period

1 year

First QC Date

February 6, 2009

Last Update Submit

September 15, 2010

Conditions

Acute Decompensated Heart Failure

Keywords

ADHFAHFHF

Outcome Measures

Primary Outcomes (1)

  • The occurence of hypotensive events, clinical symptoms, and renal function change with CD-NP infusion.

    Up to 72 hours

Study Arms (7)

A

EXPERIMENTAL

Dose 1 of CD-NP

Drug: CD-NP

B

EXPERIMENTAL

Dose 2 of CD-NP

Drug: CD-NP

C

EXPERIMENTAL

Dose 3 of CD-NP

Drug: CD-NP

D

EXPERIMENTAL

Dose 4 of CD-NP

Drug: CD-NP

E

EXPERIMENTAL

Dose 5 of CD-NP

Drug: CD-NP

F

EXPERIMENTAL

Dose 6 of CD-NP

Drug: CD-NP

G

PLACEBO COMPARATOR

Placebo

Drug: CD-NP

Interventions

CD-NPDRUG

Infusion of CD-NP at one of up to 6 doses or placebo

ABCDEFG

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Unknown Facility

Los Angeles, California, 90033, United States

Location

Unknown Facility

Torrance, California, 90509, United States

Location

Unknown Facility

Jacksonville, Florida, 32216, United States

Location

Unknown Facility

Miami Beach, Florida, 33149, United States

Location

Unknown Facility

Chicago, Illinois, 60611, United States

Location

Unknown Facility

Iowa City, Iowa, 52246, United States

Location

Unknown Facility

Detroit, Michigan, 48201, United States

Location

Unknown Facility

Minneapolis, Minnesota, 55415, United States

Location

Unknown Facility

The Bronx, New York, 10467, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

Berlin, 12351, Germany

Location

Unknown Facility

Berlin, 13353, Germany

Location

Unknown Facility

Dortmund, 44137, Germany

Location

Unknown Facility

Neuss, 41464, Germany

Location

Unknown Facility

Würzberg, 97080, Germany

Location

Unknown Facility

Ashkelon, 78278, Israel

Location

Unknown Facility

Haifa, 31096, Israel

Location

Unknown Facility

Nazareth, 16100, Israel

Location

Unknown Facility

Petah Tikva, 49100, Israel

Location

Unknown Facility

Safed, 13100, Israel

Location

Unknown Facility

Tel Aviv, 64239, Israel

Location

Study Officials

  • Hsiao Lieu, MD

    Nile Therapeutics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 6, 2009

First Posted

February 9, 2009

Study Start

June 1, 2009

Primary Completion

June 1, 2010

Study Completion

July 1, 2010

Last Updated

September 17, 2010

Record last verified: 2010-09

Locations

DE(5)IL(6)US(10)