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

Nile Therapeutics0 sites77 target enrollmentJune 2009

ConditionsAcute Decompensated Heart Failure

InterventionsCD-NP

DrugsCD-NP

Overview

Phase: Phase 2
Intervention: CD-NP
Conditions: Acute Decompensated Heart Failure
Sponsor: Nile Therapeutics
Enrollment: 77
Primary Endpoint: The occurence of hypotensive events, clinical symptoms, and renal function change with CD-NP infusion.
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2009

End Date

July 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Nile Therapeutics

Eligibility Criteria

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.

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.