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OpenTrials
Completed

NCT Number: NCT00839007

Study to Assess the Safety and Efficacy of 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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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

Treatment and study plan

CD-NP

Drug

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

Primary outcomes

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

    Time frame: Up to 72 hours

Sponsors and collaborators

Lead sponsor

Nile Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 9, 2009
Registry last updated
Sep 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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