ZP120 Add-on to Furosemide in Treatment of Acute or Sub-Acute Decompensated Heart Failure
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00283361 |
|
Recruitment Status :
Terminated
First Posted : January 27, 2006
Last Update Posted : February 28, 2007
|
Sponsor:
Zealand Pharma
Collaborator:
Syneos Health
Information provided by:
Zealand Pharma
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Heart Failure, Congestive | Drug: ZP120 Procedure: I.v. catherization Procedure: 6-minutes walk performance Behavioral: Dyspnea severity assessment Procedure: Blood sampling for laboratory tests Procedure: ECG Procedure: Physical examination | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 130 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Study Start Date : | January 2006 |
| Study Completion Date : | December 2006 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Heart Failure
Primary Outcome Measures :
- Change in dyspnea severity
Secondary Outcome Measures :
- Change in 6-minute walk test performance
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- I.v. vasoactive treatment, e.g. vasodilators, positive inotropic agents, within 24 hours prior to enrollment (see details in Appendix E)
- Participation in another study evaluating an experimental treatment within the last 30 days which potentially could bias the outcome of this study
- Previous treatment with ZP120
- Patients known to abuse or actively abusing alcohol or illicit drugs. Abuse of alcohol is defined as the usual daily intake of more than 100 grams of ethanol per day, or more than approximately six 12-ounce bottles of beer, one 750 mL bottle of wine, or 250 mL of 80 proof spirits
- Inability or unwillingness to provide informed consent
- BMI outside range of 20-50 kg/m2 (BMI equal to 20 and 50 kg/m2 is accepted)
- Any other condition or therapy, which in the opinion of the Principal Investigator would make the patient unsuitable for this study
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00283361
Locations
Show 22 study locations
Sponsors and Collaborators
Zealand Pharma
Syneos Health
| ClinicalTrials.gov Identifier: | NCT00283361 |
| Other Study ID Numbers: |
05-025 |
| First Posted: | January 27, 2006 Key Record Dates |
| Last Update Posted: | February 28, 2007 |
| Last Verified: | February 2007 |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |