A Study Testing the Effectiveness of Nesiritide in Patients With Acute Decompensated Heart Failure

NCT ID: NCT00475852

Last Updated: 2013-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 7141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2011-03-31

Brief Summary

The purpose of this study is to find out if nesiritide (a human B-type natriuretic peptide/hBNP) as compared to placebo, plus the usual treatment for acute decompensated heart failure, helps to improve breathing difficulties, reduce heart failure readmissions to hospitals, and helps patients live longer.

Detailed Description

Acute Decompensated Heart Failure (ADHF) is the inability of the heart to pump efficiently, which can result in symptoms like shortness of breath at rest or with minimal activity. ADHF is a condition in which the heart cannot perform the necessary circulation of blood through the body. This is a randomized (study medication is assigned by chance), double-blind (neither the patient or the doctor knows whether the patient is assigned to receive study drug or placebo [does not contain study drug]), placebo-controlled, parallel group, multicenter study of the effectiveness of nesiritide administered continuously through a vein for a minimum of 24 hours up to a maximum of 7 days. The study hypothesis is that nesiritide given in addition to standard care is superior to placebo given in addition to standard care as measured by relief of breathing difficulties (by patient evaluation utilizing a breathlessness scale) at 6 hours or 24 hours after nesiritide administration, and reduction in rehospitalization due to heart failure and death from study drug administration through Day 30. The study drug (nesiritide) or placebo dose being studied is 0.010 mcg/kg/min with or without a 2 mcg/kg initial bolus (one time injection) of nesiritide. Patient safety will be monitored throughout the study through physical exams, vital signs (heart rate, blood pressure, respiratory rate, and temperature), blood tests, and side effects. The patients assigned to the nesiritide group will receive a continuous intravenous (into a vein) infusion at 0.010 mcg/kg/min of nesiritide with or without a 2 mcg/kg bolus (one time injection). The patients assigned to the placebo group will receive matching placebo bolus and infusion. The bolus is given over one minute and the continuous infusion is given for at least 24 hours and up to 7 days.

Conditions

Heart Decompensation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

001

Nesiritide 0.01 mcg/kg/min intravenous (IV) infusion (with or without 2 mcg/kg bolus) for 24 to 168 hours (hrs)

Group Type: EXPERIMENTAL

Nesiritide

Intervention Type: DRUG

0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs

002

Placebo matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs

Interventions

Nesiritide

0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs

Intervention Type: DRUG

Placebo

matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Hospitalized for the management of acute decompensated heart failure (ADHF) or diagnosed with ADHF within 48 hours after being hospitalized for another reason; Diagnosis of ADHF is defined as dyspnea (difficulty breathing) at rest or dyspnea with minimal activity.

Exclusion Criteria

At high risk for hypotension (low blood pressure); Acute coronary syndrome as primary diagnosis; History of cardiac valvular stenosis, restrictive cardiomyopathy, hypertrophic cardiomyopathy, or pericardial tamponade; Previous enrollment in a nesiritide study; Persistent, uncontrolled hypertension (SBP [systolic blood pressure] >180 mmHg).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Scios, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scios, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Scios, Inc.

Locations

Huntsville, Alabama, United States

Mobile, Alabama, United States

Anchorage, Alaska, United States

Gilbert, Arizona, United States

Scottsdale, Arizona, United States

Fort Smith, Arkansas, United States

Jonesboro, Arkansas, United States

Berkeley, California, United States

Culver City, California, United States

Escondido, California, United States

Inglewood, California, United States

Loma Linda, California, United States

Los Angeles, California, United States

Mission Viejo, California, United States

Sacramento, California, United States

San Diego, California, United States

Santa Ana, California, United States

Torrance, California, United States

Ventura, California, United States

Denver, Colorado, United States

Englewood, Colorado, United States

Fort Collins, Colorado, United States

Hartford, Connecticut, United States

New Haven, Connecticut, United States

Newark, Delaware, United States

Washington D.C., District of Columbia, United States

Clearwater, Florida, United States

Fort Lauderdale, Florida, United States

Gainesville, Florida, United States

Inverness, Florida, United States

Lakeland, Florida, United States

Melbourne, Florida, United States

Miami Beach, Florida, United States

Ocala, Florida, United States

Orlando, Florida, United States

Tallahassee, Florida, United States

Tampa, Florida, United States

Winter Haven, Florida, United States

Atlanta, Georgia, United States

Augusta, Georgia, United States

Gainesville, Georgia, United States

Macon, Georgia, United States

Aurora, Illinois, United States

Chicago, Illinois, United States

Downers Grove, Illinois, United States

Elk Grove Village, Illinois, United States

Hinsdale, Illinois, United States

La Grange, Illinois, United States

Maywood, Illinois, United States

Mokena, Illinois, United States

Oakbrook Terrace, Illinois, United States

Peoria, Illinois, United States

Rockford, Illinois, United States

Springfield, Illinois, United States

Anderson, Indiana, United States

Indianapolis, Indiana, United States

Munster, Indiana, United States

South Bend, Indiana, United States

Valparaiso, Indiana, United States

Danville, Kentucky, United States

Edgewood, Kentucky, United States

Lexington, Kentucky, United States

Owensboro, Kentucky, United States

Baltimore, Maryland, United States

Randallstown, Maryland, United States

Rockville, Maryland, United States

Boston, Massachusetts, United States

Brighton, Massachusetts, United States

Springfield, Massachusetts, United States

Worcester, Massachusetts, United States

Bay City, Michigan, United States

Detroit, Michigan, United States

Flint, Michigan, United States

Lansing, Michigan, United States

Monroe, Michigan, United States

Petoskey, Michigan, United States

Pontiac, Michigan, United States

Saginaw, Michigan, United States

Troy, Michigan, United States

Minneapolis, Minnesota, United States

Tupelo, Mississippi, United States

Kansas City, Missouri, United States

Springfield, Missouri, United States

St Louis, Missouri, United States

Lincoln, Nebraska, United States

Omaha, Nebraska, United States

Papillion, Nebraska, United States

Manchester, New Hampshire, United States

Browns Mills, New Jersey, United States

Camden, New Jersey, United States

Elmer, New Jersey, United States

Hackensack, New Jersey, United States

Neptune City, New Jersey, United States

Newark, New Jersey, United States

Paterson, New Jersey, United States

Ridgewood, New Jersey, United States

Toms River, New Jersey, United States

Trenton, New Jersey, United States

Turnersville, New Jersey, United States

Albany, New York, United States

Brooklyn, New York, United States

Elmhurst, New York, United States

Johnson City, New York, United States

New Hyde Parke, New York, United States

Poughkeepsie, New York, United States

Rochester, New York, United States

Roslyn, New York, United States

Saratoga Springs, New York, United States

Stony Brook, New York, United States

The Bronx, New York, United States

Valhalla, New York, United States

Asheville, North Carolina, United States

Chapel Hill, North Carolina, United States

Charlotte, North Carolina, United States

Durham, North Carolina, United States

Gastonia, North Carolina, United States

Greenville, North Carolina, United States

Winston-Salem, North Carolina, United States

Akron, Ohio, United States

Canton, Ohio, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Columbus, Ohio, United States

Dayton, Ohio, United States

Garfield Heights, Ohio, United States

Mansfield, Ohio, United States

Mayfield Heights, Ohio, United States

Middletown, Ohio, United States

Sylvania, Ohio, United States

Toledo, Ohio, United States

Youngstown, Ohio, United States

Midwest City, Oklahoma, United States

Oklahoma City, Oklahoma, United States

Tulsa, Oklahoma, United States

Bend, Oregon, United States

Abington, Pennsylvania, United States

Allentown, Pennsylvania, United States

Beaver, Pennsylvania, United States

Bethlehem, Pennsylvania, United States

Camp Hill, Pennsylvania, United States

Danville, Pennsylvania, United States

Harrisburg, Pennsylvania, United States

Lancaster, Pennsylvania, United States

Natrona Heights, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

York, Pennsylvania, United States

Anderson, South Carolina, United States

Charleston, South Carolina, United States

Greenville, South Carolina, United States

Spartanburg, South Carolina, United States

Sumter, South Carolina, United States

Rapid City, South Dakota, United States

Kingsport, Tennessee, United States

Memphis, Tennessee, United States

Nashville, Tennessee, United States

Oak Ridge, Tennessee, United States

Amarillo, Texas, United States

Dallas, Texas, United States

Fort Worth, Texas, United States

Houston, Texas, United States

Tyler, Texas, United States

Falls Church, Virginia, United States

Harrisonburg, Virginia, United States

Lynchburg, Virginia, United States

Norfolk, Virginia, United States

Winchester, Virginia, United States

Tacoma, Washington, United States

Burlington, Wisconsin, United States

Madison, Wisconsin, United States

Milwaukee, Wisconsin, United States

Buenos Aires, , Argentina

Córdoba, , Argentina

La Plata, , Argentina

Mar del Plata, , Argentina

San Miguel de Tucumán, , Argentina

Santa Fe, , Argentina

Bedford, , Australia

Camperdown, , Australia

Concord, , Australia

Darlinghurst, , Australia

Elizabeth Vale, , Australia

Fitzroy, , Australia

Hobart, , Australia

Kogarah, , Australia

Launceston, , Australia

Melbourne, , Australia

Randwick, , Australia

Belo Horizonte, , Brazil

Campinas, , Brazil

Curitiba, , Brazil

Fortaleza, , Brazil

Goiânia, , Brazil

Porto Alegre, , Brazil

Recife, , Brazil

Rio de Janeiro-Rj, , Brazil

Salvador, , Brazil

São José do Rio Preto, , Brazil

São Paulo, , Brazil

Pleven, , Bulgaria

Sofia, , Bulgaria

Varna, , Bulgaria

Calgary, Alberta, Canada

Edmonton, Alberta, Canada

Red Deer, Alberta, Canada

Campbell River, British Columbia, Canada

Kelowna, British Columbia, Canada

Maple Ridge, British Columbia, Canada

New Westminster, British Columbia, Canada

Surrey, British Columbia, Canada

Vancouver, British Columbia, Canada

Victoria, British Columbia, Canada

Lakeland, Manitoba, Canada

Winnipeg, Manitoba, Canada

Halifax, Nova Scotia, Canada

Ajax, Ontario, Canada

Brampton, Ontario, Canada

Cornwall, Ontario, Canada

Hamilton, Ontario, Canada

Kitchener, Ontario, Canada

Ottawa, Ontario, Canada

Scarborough Village, Ontario, Canada

Toronto, Ontario, Canada

Granby, Quebec, Canada

Laval, Quebec, Canada

Montreal, Quebec, Canada

Saint-Charles-Borromée, Quebec, Canada

Sherbrooke, Quebec, Canada

Ste-Foy, Quebec, Canada

Terrebonne, Quebec, Canada

Santiago, , Chile

Santiago Rm, , Chile

Temuco, , Chile

Beijing, , China

Beijing Prc, , China

Guangdong Province, , China

Hangzhou, , China

Jinan, , China

Shanghai, , China

Tianjin, , China

Xi'an, , China

Barranquilla, , Colombia

Bogotá Dc, , Colombia

Floridablanca, , Colombia

Colmar, , France

Paris, , France

Poitiers, , France

Pontoise, , France

Thionville Cedex N/A, , France

Toulouse, , France

Valenciennes, , France

Vandœuvre-lès-Nancy, , France

Bad Krozingen, , Germany

Berlin, , Germany

Brandenburg, , Germany

Ludwigshafen, , Germany

Lüdenscheid, , Germany

Neuruppin, , Germany

Athens, , Greece

Larissa, , Greece

Thessalonikis, , Greece

Volos, , Greece

Ahmedabad, , India

Bengaluru, , India

Coimbatore, , India

Hyderabad, , India

Nagpur, , India

Pune, , India

Vadodara, , India

Hadera, , Israel

Haifa, , Israel

Holon, , Israel

Petah Tikva, , Israel

Ramat Gan, , Israel

Safed, , Israel

Kaunas, , Lithuania

Vilnius Lt, , Lithuania

Johor Bahru, , Malaysia

Kuala Lumpur, , Malaysia

Aguascalientes, , Mexico

Guadalajara, , Mexico

San Luis Potosí City, , Mexico

Sinaloa, , Mexico

Zapopan, , Mexico

Amersfoort, , Netherlands

Delft, , Netherlands

Gorinchem, , Netherlands

Groningen, , Netherlands

Leeuwarden, , Netherlands

Sneek, , Netherlands

Auckland, , New Zealand

Christchurch, , New Zealand

Hamilton, , New Zealand

Hastings, , New Zealand

Lower Hutt, , New Zealand

Nelson, , New Zealand

Stavanger, , Norway

Trondheim, , Norway

Tønsberg, , Norway

Bydgoszcz, , Poland

Gdynia, , Poland

Krakow, , Poland

Ostrowiec Świętokrzyski, , Poland

Skierniewice, , Poland

Warsaw, , Poland

Wroclaw, , Poland

Kemerovo, , Russia

Moscow, , Russia

Tomsk, , Russia

Tyumen, , Russia

Yekaterinburg, , Russia

Singapore, , Singapore

Chungcheongbuk-Do, , South Korea

Seoul, , South Korea

Falun, , Sweden

Uppsala, , Sweden

Kaohsiung City, , Taiwan

Taipei, , Taiwan

Taoyuan District, , Taiwan

Bangkok, , Thailand

Khon Kaen, , Thailand

Dnipro, , Ukraine

Donetsk, , Ukraine

Kharkiv, , Ukraine

Lviv, , Ukraine

Mykolayiv, , Ukraine

Vinnitsa, , Ukraine

Zaporizhzhya, , Ukraine

Countries

United States; Argentina; Australia; Brazil; Bulgaria; Canada; Chile; China; Colombia; France; Germany; Greece; India; Israel; Lithuania; Malaysia; Mexico; Netherlands; New Zealand; Norway; Poland; Russia; Singapore; South Korea; Sweden; Taiwan; Thailand; Ukraine

References

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Related Links

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A study testing the effectiveness of Nesiritide in Patients with Acute Decompensated Heart Failure

Other Identifiers

ASCEND-HF

Identifier Type: OTHER

Identifier Source: secondary_id

A093

Identifier Type: OTHER

Identifier Source: secondary_id

NATRECORAHF3002

Identifier Type: OTHER

Identifier Source: secondary_id

CR013954

Identifier Type: -

Identifier Source: org_study_id