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Management of Patients with Congestive Heart Failure After Hospitalization Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Management of Patients with Congestive Heart Failure After Hospitalization conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Management of Patients with Congestive Heart Failure After Hospitalization Clinical research trials and Management of Patients with Congestive Heart Failure After Hospitalization health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Management of Patients with Congestive Heart Failure After Hospitalization. Management of Patients with Congestive Heart Failure After Hospitalization Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Management of Patients with Congestive Heart Failure After Hospitalization clinical trial. Participants oftentimes recieve the most expert healthcare available for their Management of Patients with Congestive Heart Failure After Hospitalization condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "M" Clinical Trials Conditions > Management of Patients with Congestive Heart Failure After Hospitalization  Management of Patients with Congestive Heart Failure After Hospitalization
Management of Patients with Congestive Heart Failure After Hospitalization
For Condition: Heart Failure, Congestive
Status: No longer recruiting
Sponsor(s): Scios ,
Synopsis: The objective of this study is to assess the safety and tolerability of different doses of Natrecor® when administered serially to patients with decompensated CHF who are concomitantly receiving their usual cardiac medications and are at high risk for hospitalization.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for participation in the study - Age _ 18 years. - At least two hospital admissions or equivalent treatment (e.g., Emergency Department/observation unit admissions or unscheduled clinic visits) with IV vasoactive agents (such as IV inotropes, Natrecor®, or nitroglycerin for acutely decompensated CHF) within the last 12 months, with at least one of these admissions in the past 30 days. (Note: Infusions of diuretics in an outpatient setting should not be counted as a treatment to satisfy this inclusion criteria. The major reason for a hospital admission should be for the treatment of acutely decompensated CHF). - Able to be enrolled and initiate treatment with study drug within 5–30 days of last hospital discharge or equivalent treatment of acutely decompensated CHF. - Baseline NYHA Functional Classification III/IV for at least 2 months prior to randomization (see Appendix 4). - Receiving optimal treatment with long term oral medications (e.g., diuretics, ACE inhibitors, and beta blockers, unless beta blockers or ACE inhibitors are documented to be contraindicated or not tolerated). - Ambulatory and able to participate in the 6-minute walk test. - Result of 6-minute walk test is < 400 meters. - Have available transportation and are able to attend clinic visits at least once weekly for 12 weeks. - Agree to come in to the clinic at least one time each week for 13 weeks and to be available for follow up for three additional weeks. - Agree to receive infusions of Natrecor®, or possibly other medications, at least as frequently as once per week for 12 weeks. - Females of childbearing potential must be willing to use two forms of contraception. - Understood, and signed a written Informed Consent Form before initiation of protocol specified procedures. Exclusion Criteria: Patients meeting any of the following exclusion criteria are not eligible for participation in the study - Systolic blood pressure consistently less than 90 mm Hg. - Have had or during the course of the study are anticipated to have any organ transplantation (heart, liver, lung, and kidney). - Unable or unwilling to discontinue intermittent or continuous infusions of inotropes if randomized to a Natrecor® treatment group. - Have had a bi-ventricular pacemaker placed within past 60 days or an automatic implantable cardiac defibrillator (AICD) placed within the past 30 days. - Have left ventricular assist device in place (LVAD). - Cardiogenic shock, volume depletion, or any other clinical condition that would contraindicate the administration of Natrecor®. - Currently receiving chronic dialysis or the expectation that dialysis will be required during the course of the study. - Possible allergic reaction or sensitivity to Natrecor®. - Females of child bearing potential with a positive pregnancy test, pregnant or nursing mothers, or suspected pregnancy. - Medical condition so severe that survival for the treatment and follow-up periods is not likely. - Medical condition immediately prior to randomization is such that hospitalization is needed or probably imminent. - Concurrent therapy with another investigational drug or device without prior approval from Scios. - Unwillingness or inability to comply with study requirements including informed consent, weekly clinic visits, and the follow-up period. - Evidence of acute myocardial infarction within the past 30 days.
Total Enrollment:
Location and Contact Information:
Spectrum Health - Cook Research
Grand Rapids, Michigan, 49506
United States
St. Paul University Hospital
Dallas, Texas, 75390
United States
Ohio State University
Columbus, Ohio, 43210
United States
Central Cardiovascular Institute of San Antonio
San Antonio, Texas, 78215
United States
St. Vincent's Medical Center
Bridgeport, Connecticut, 06606
United States
Jackson Heart Clinic, PA
Jackson, Mississippi, 39216
United States
The Heart and Vascular Institute of Florida
St. Petersburg, Florida, 33701
United States
St. Lukes Episcopal Hospital
Houston, Texas, 77030
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
Tulane University & Health Science Center
New Orleans, Louisiana, 70112
United States
HeartCare Midwest
Peoria, Illinois, 61603
United States
Mid America Heart Institute
Kansas City, Missouri, 64111
United States
Albany Memorial Hospital
Albany, New York, 12201
United States
Kaiser Permanente Mid-Atlantic States
Rockville, Maryland, 20852
United States
Emory University Hospital Heat Failure Clinic
Atlanta, Georgia, 30322
United States
University of North Carolina Hospitals
Chapel Hill, North Carolina, 27599
United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267-0542
United States
Cardiology Consultants; South Bay Cardiovascular Associates; Long Island Cardiology Associates, PLLC; North Suffolk Associates, PC
Woodbury, New York, 11797
United States
St. Elizabeth Health Center
Youngstown, Ohio, 44501
United States
The University of Alabama at Birmingham
Birmingham, Alabama, 35294-0006
United States
Via Christi Regional Medical Center
Wichita, Kansas, 67214
United States
Cardiology Associates of North Mississippi
Tupelo, Mississippi, 38801
United States
Cardiovascular Institute of the South; Terrebonne General Medical Center
Houma, Louisiana, 70360
United States
Desert Cardiology Consultants Medical Group, Inc.
Rancho Mirage, California, 92270
United States
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
United States
The Lindner Clinical Trial Center
Cincinnati, Ohio, 45219
United States
Alaska Heart Institute
Anchorage, Alaska, 99508
United States
Florida Heart Institute
Orlando, Florida, 32803
United States
Hackensack University Hospital
Hackensack, New Jersey, 07601
United States
University of Miami/Jackson Memorial Medical Center
Miami, Florida, 33136
United States
VA San Diego Health Care System
San Diego, California, 92161
United States
Good Samaritan Hospital
Baltimore, Maryland, 21239
United States
Cardiology Associates of Mobile, Inc.; Providence Hospital
Mobile, Alabama, 36608
United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
United States
Arizona Heart Institute; Arizona Heart Hospital
Phoenix, Arizona, 85006
United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Evanston Northwestern Healthcare
Evanston, Illinois, 60201
United States
DuPage Medical Center
Winfield, Illinois, 60190
United States
Foundation Research
St. Petersburg, Florida, 33705
United States
Carle Heart Center
Urbana, Illinois, 61801
United States
University of Kentucky College of Medicine
Lexington, Kentucky, 40536
United States
Willis-Knighton Health System; Cardiac Centers of Louisiana, LLC
Shreveport, Louisiana, 71103
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
The Queen's Medical Center
Honolulu, Hawaii, 96813
United States
Guthrie Foundation for Education and Research
Sayre, Pennsylvania, 18840
United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
United States
Medical Speciality Clinic
Jackson, Tennessee, 38301
United States
Clearwater Cardiovascular and Interventional Consultants
Clearwater, Florida, 33756
United States
Shadyside Hospital
Pittsburgh, Pennsylvania, 15206
United States
Salem Cardiology Associates
Salem, Oregon, 97302
United States
Geisinger Medical Center
Danville, Pennsylvania, 17822
United States
Midwest Heart Research Foundation
Lombard, Illinois, 60148
United States
Cardiology Associates of West Reading, LTD.; The Reading Hospital and Medical Center
West Reading, Pennsylvania, 19611
United States
Additional Information:
Study ID Numbers: 704.348;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00040612
Other Heart Failure, Congestive Studies:
1. Epidemiology of Cardiotoxicity in Children with Cancer
2. Enoximone Plus Extended-Release Metoprolol Succinate in Subjects with Advanced Chronic Heart Failure
3. Digitalis Investigation Group (DIG)
4. Beta-Blocker Evaluation in Survival Trial (BEST)
5. Heart Failure Adherence and Retention Trial (HART)
Related Studies:
Other Heart Failure, Congestive Clinical Trials
Other Florida Clinical Trials
Other St. Petersburg Clinical Trials
Management of Patients with Congestive Heart Failure After Hospitalization
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