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Heart Failure, CongestivePhase 2NCT00283361

ZP120 Add-on to Furosemide in Treatment of Acute or Sub-Acute Decompensated Heart Failure

A Phase 2 study testing ZP120, I.v. catherization and 6-minutes walk performance in people with Heart Failure, Congestive, run by Zealand Pharma at 22 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Congestive
What is being tested?
ZP120, I.v. catherization and 6-minutes walk performance
How many people
130 participants
Where
22 sitesUnited States
Study dates
Jan 2006to Dec 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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)
  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

United States22 sites

  • Community Hospital Anderson/Community Clinical Research Center

    Anderson, Indiana, 46011

  • Emory University Hospital/The Emory Clinic

    Atlanta, Georgia, 30322

  • Northside Hospital

    Atlanta, Georgia, 30342

  • University of Maryland

    Baltimore, Maryland, 21201

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • University of CO Health Sciences Center

    Denver, Colorado, 123456

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • University of Iowa Heart Failure Treatment Program

    Iowa City, Iowa, 52242

  • Lancaster Heart Foundation

    Lancaster, Pennsylvania, 17603

  • Bryan LGH Heart Institute

    Lincoln, Nebraska, 68510

  • LAC-USC Medical Center-Division of Cardiology

    Los Angeles, California, 90073

  • VA Medical Center -WLA

    Los Angeles, California, 90073

  • Health First Clinical Research Institute

    Melbourne, Florida, 32901

  • Univ. of Miami Miller School of Medicine, Jackson Memorial Medical Center

    Miami, Florida, 33136

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • The International Heart Institute

    Missoula, Montana, 59802

  • Albert Einstein Medical Center

    Philadelphia, Pennsylvania, 19141

  • University of Rochester Medical Center

    Rochester, New York, 14618

  • Alamo Clinical Research Associates

    San Antonio, Texas, 78212

  • UCSD Medical Center

    San Diego, California, 92103-8411

  • San Francisco VA Medical Center

    San Francisco, California, 94121

Other trials in United States

About this study

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

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.

Being tested
ZP120, I.v. catherization, 6-minutes walk performance, Dyspnea severity assessment, Blood sampling for laboratory tests
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZP120Drug

  • I.v. catherizationProcedure or surgery

  • 6-minutes walk performanceProcedure or surgery

  • Dyspnea severity assessmentBehavioural

  • Blood sampling for laboratory testsProcedure or surgery

  • ECGProcedure or surgery

  • Physical examinationProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in dyspnea severity

Secondary outcomes (1)

  1. Change in 6-minute walk test performance

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2006 (estimated)
  2. Study startJan 2006
  3. Study completionDec 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
130 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00283361
Sponsor's protocol ID
05-025
Status last verified
Feb 2007
First submitted
25 Jan 2006
Last updated
28 Feb 2007
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ZP120, I.v. catherization and 6-minutes walk performance in people with Heart Failure, Congestive, run by Zealand Pharma at 22 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in dyspnea severity. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00283361.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2007.

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