ZP120 Add-on to Furosemide in Treatment of Acute or Sub-Acute Decompensated Heart Failure
A Phase II,Randomized, Double-Blind, Flexible Dose Study of ZP120 I.V. Infusion as Add-On Therapy in Patients With Acute or Sub-Acute Decompensated Chronic Heart Failure NYHA Class III-IV Treated With Furosemide
1 other identifier
interventional
130
1 country
22
Brief Summary
The main purpose of this study is to see if the experimental drug ZP120, when given with the approved drug furosemide to patients with acute or sub-acute heart failure, can reduce the amount of fluid in the patients' lungs and make breathing easier.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2006
Shorter than P25 for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 25, 2006
CompletedFirst Posted
Study publicly available on registry
January 27, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedFebruary 28, 2007
February 1, 2007
January 25, 2006
February 27, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
Change in dyspnea severity
Secondary Outcomes (1)
Change in 6-minute walk test performance
Interventions
Eligibility Criteria
You may qualify if:
- Male or female patients, age 18 years or more
- A diagnosis of acute or subacute decompensated chronic heart failure, either ischemic or nonischemic, requiring hospitalization, and currently treated with furosemide, torsemide, or bumetadine, and other evidence based optimal treatment for heart failure. Patients must have the clinical diagnosis of CHF made at least 3 month prior to enrollment
- Ambulatory
- Objective signs of LVD corresponding to a LVEF \< 45%, documented by any accepted method within the previous 12 months. If documentation is not available within the required time frame, LVEF must be assessed prior to enrollment
- a) Worsening heart failure symptoms (current NYHA class III-IV). Patients must experience worsening of at least one of the symptoms described below at the time of entry into the study:
- Dyspnea Symptoms:
- Dyspnea (labored or difficult breathing) at rest
- Worsening dyspnea (labored or difficult breathing) on minimal exertion
- Worsening orthopnea (difficult breathing except in the upright position)
- Increased frequency of nocturnal dyspnea (awaken from sleep due to respiratory distress)
- b) Clinical evidence of volume overload such as weight gain over previous few days, peripheral edema, hepatic congestion with ascites, pulmonary congestion, or pleural effusion
- Females of childbearing potential must have a negative pregnancy test at enrollment. A female is considered to be of childbearing potential unless she is post-menopausal (no menses for at least 12 consecutive months) or without a uterus and/or both ovaries
- Ability to understand and willing to sign Informed Consent Form
You may not qualify if:
- Incapable of taking the 6-minute walk test due to any condition unrelated to heart failure, e.g., muscular or skeletal disability
- Valvular heart disease requiring surgical intervention (during the course of the study. Patients with heart failure due to or associated with uncorrected primary valvular disease, malfunctioning artificial heart valve, or uncorrected congenital heart disease)
- History of or clinically significant evidence of any severe disease other than heart failure that preclude participation and complicate the evaluation of study results from the local laboratory:
- Hepatic disease (AST, ALT, total bilirubin \> 3 times Upper Limit of Normal (ULN), renal disease (S-Creatinine \> 2.5 mg/dL),
- Uncontrolled insulin-dependent diabetes mellitus with a history of frequent hypoglycemic episodes or frequent hospitalizations for hyperglycemia,
- Cancer (excluding treated non-melanoma skin cancer)
- Unstable angina, cardiogenic shock, or acute pulmonary edema requiring any of the following: Nitroprusside, intravenous nitroglycerin, nesiritide, intravenous inotrope, or need for endotracheal intubation and mechanical ventilation
- Acute myocardial infarction and/or myocardial infarction within 30 days (prior to enrollment) as diagnosed by investigator's evaluation of clinical symptoms, ECG, and/or biochemical markers of cardiac injury
- Cardiac arrest (patients with history of cardiac arrest within 12 months unless precipitated by an event such as an acute myocardial infarction, induction by catheter placement, severe transient electrolyte abnormality, by an electrophysiology procedure, or addressed by Automatic Implantable Cardioverter Defibrillator placement. Patients with increased risk of cardiac arrest, QTc \> 450 msec, atrial ventricular block II or III, etc.)
- Sustainable VT/VF within 30 days (\> 15 seconds long; patients with enrollment ECG showing ventricular tachycardia or premature ventricular complexes associated with symptoms, or ventricular tachycardia of 6 beats)
- Uncontrolled atrial fibrillation on enrollment ECG with a ventricular rate \>120 bpm
- Cardiac surgery within the last month or acutely required PCI (patients who have undergone a cardiac revascularization, valvular surgery, or biventricular resynchronization procedure within 30 days. Patients who have had ventricular reduction surgery or cardiac myoplasty and patients with mechanical ventricular assist device)
- Systolic blood pressure \< 90 mmHg and \> 200 mmHg
- Pulmonary embolism or DVT or history of pulmonary embolism or DVT within 6 months prior to enrollment
- Severe obstructive or restrictive pulmonary disease, patients with primary pulmonary hypertension and heart failure secondary to pulmonary disease, and severe pulmonary infection
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zealand Pharmalead
- Syneos Healthcollaborator
Study Sites (22)
LAC-USC Medical Center-Division of Cardiology
Los Angeles, California, 90073, United States
VA Medical Center -WLA
Los Angeles, California, 90073, United States
UCSD Medical Center
San Diego, California, 92103-8411, United States
San Francisco VA Medical Center
San Francisco, California, 94121, United States
University of CO Health Sciences Center
Denver, Colorado, 123456, United States
Health First Clinical Research Institute
Melbourne, Florida, 32901, United States
Univ. of Miami Miller School of Medicine, Jackson Memorial Medical Center
Miami, Florida, 33136, United States
Emory University Hospital/The Emory Clinic
Atlanta, Georgia, 30322, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Community Hospital Anderson/Community Clinical Research Center
Anderson, Indiana, 46011, United States
University of Iowa Heart Failure Treatment Program
Iowa City, Iowa, 52242, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
The International Heart Institute
Missoula, Montana, 59802, United States
Bryan LGH Heart Institute
Lincoln, Nebraska, 68510, United States
University of Rochester Medical Center
Rochester, New York, 14618, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Lancaster Heart Foundation
Lancaster, Pennsylvania, 17603, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141, United States
Alamo Clinical Research Associates
San Antonio, Texas, 78212, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 25, 2006
First Posted
January 27, 2006
Study Start
January 1, 2006
Study Completion
December 1, 2006
Last Updated
February 28, 2007
Record last verified: 2007-02