Study to Assess the Safety and Efficacy of CD-NP in the Treatment of Patients With Acute Decompensated Heart Failure

This study has been completed.
Sponsor:
Information provided by:
Nile Therapeutics
ClinicalTrials.gov Identifier:
NCT00839007
First received: February 6, 2009
Last updated: September 15, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Acute Decompensated Heart Failure
Drug: CD-NP
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Nile Therapeutics:

Primary Outcome Measures:
  • The occurence of hypotensive events, clinical symptoms, and renal function change with CD-NP infusion. [ Time Frame: Up to 72 hours ] [ Designated as safety issue: Yes ]

Enrollment: 77
Study Start Date: June 2009
Study Completion Date: July 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Dose 1 of CD-NP
Drug: CD-NP
Infusion of CD-NP at one of up to 6 doses or placebo
Experimental: B
Dose 2 of CD-NP
Drug: CD-NP
Infusion of CD-NP at one of up to 6 doses or placebo
Experimental: C
Dose 3 of CD-NP
Drug: CD-NP
Infusion of CD-NP at one of up to 6 doses or placebo
Experimental: D
Dose 4 of CD-NP
Drug: CD-NP
Infusion of CD-NP at one of up to 6 doses or placebo
Experimental: E
Dose 5 of CD-NP
Drug: CD-NP
Infusion of CD-NP at one of up to 6 doses or placebo
Experimental: F
Dose 6 of CD-NP
Drug: CD-NP
Infusion of CD-NP at one of up to 6 doses or placebo
Placebo Comparator: G
Placebo
Drug: CD-NP
Infusion of CD-NP at one of up to 6 doses or placebo

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Hospitalized for acute decompensated heart failure.
  2. Systolic blood pressure ≥ 115 mmHg and ≤ 200 mmHg, and diastolic blood pressure ≥ 60 mmHg and ≤ 110 mmHg at screening
  3. Renally compromised.
  4. Female patients must be post-menopausal or surgically sterile.

Key Exclusion Criteria:

  1. Acute or suspected acute myocardial infarction (AMI) or troponin levels > 3X the upper limit of normal at the institution's local laboratory
  2. Cardiogenic shock
  3. Evidence of uncorrected volume or sodium depletion other clinical condition that would predispose the patient to adverse events
  4. Clinically significant aortic or mitral valve stenosis
  5. Temperature >38°C (oral or equivalent), sepsis or active infection requiring IV anti-microbial treatment
  6. ADHF due to significant arrhythmias
  7. Severe renal failure defined as creatinine clearance < 30 mL/min
  8. Current or planned ultrafiltration, hemofiltration, or dialysis
  9. Significant pulmonary disease
  10. Major neurologic event, including cerebrovascular events in the prior 60 days.
  11. Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (not including restrictive mitral filling patterns)
  12. Known hypersensitivity or allergy to natriuretic peptide or its components, nesiritide, other natriuretic peptides or related compounds
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00839007

Locations
United States, California
Los Angeles, California, United States, 90033
Torrance, California, United States, 90509
United States, Florida
Jacksonville, Florida, United States, 32216
Miami Beach, Florida, United States, 33149
United States, Illinois
Chicago, Illinois, United States, 60611
United States, Iowa
Iowa City, Iowa, United States, 52246
United States, Michigan
Detroit, Michigan, United States, 48201
United States, Minnesota
Minneapolis, Minnesota, United States, 55415
United States, New York
Bronx, New York, United States, 10467
United States, Texas
Houston, Texas, United States, 77030
Germany
Berlin, Germany, 12351
Berlin, Germany, 13353
Dortmund, Germany, 44137
Neuss, Germany, 41464
Wuerzberg, Germany, 97080
Israel
Ashkelon, Israel, 78278
Haifa, Israel, 31096
Nazareth, Israel, 16100
Petach-Tikva, Israel, 49100
Safed, Israel, 13100
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Nile Therapeutics
Investigators
Study Director: Hsiao Lieu, MD Nile Therapeutics
  More Information

Additional Information:
No publications provided

Responsible Party: Hsiao Lieu, MD, Vice President, Clinical Research, Nile Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00839007     History of Changes
Other Study ID Numbers: NIL-CDNP-CT005
Study First Received: February 6, 2009
Last Updated: September 15, 2010
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Israel: Ministry of Health

Keywords provided by Nile Therapeutics:
ADHF
AHF
HF

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014