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

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.

Study Overview

• Status: Completed
• Conditions: Acute Decompensated Heart Failure
• Intervention / Treatment: Drug: CD-NP

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
  • Berlin, Germany, 12351
  • 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
• United States
  • California
    • Los Angeles, California, United States, 90033
    • Torrance, California, United States, 90509
  • Florida
    • Jacksonville, Florida, United States, 32216
    • Miami Beach, Florida, United States, 33149
  • Illinois
    • Chicago, Illinois, United States, 60611
  • Iowa
    • Iowa City, Iowa, United States, 52246
  • Michigan
    • Detroit, Michigan, United States, 48201
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
  • New York
    • Bronx, New York, United States, 10467
  • Texas
    • Houston, Texas, United States, 77030

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The occurence of hypotensive events, clinical symptoms, and renal function change with CD-NP infusion.	Up to 72 hours

Collaborators and Investigators

• Sponsor: Nile Therapeutics
• Investigators: Study Director: Hsiao Lieu, MD, Nile Therapeutics

Publications and helpful links

Helpful Links

• Sponsor website

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: February 6, 2009
• First Submitted That Met QC Criteria: February 6, 2009
• First Posted (Estimate): February 9, 2009

Study Record Updates

• Last Update Posted (Estimate): September 17, 2010
• Last Update Submitted That Met QC Criteria: September 15, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: HF; ADHF; AHF
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: NIL-CDNP-CT005