Double-Blind, Placebo-Controlled, Multicenter Acute Study of Clinical Effectiveness of Nesiritide in Subjects With Decompensated Heart Failure - ASCEND-HF

• Register: EUCTR
• Last refreshed on: 3 September 2012
• Main ID: EUCTR2007-001670-84-IT
• Date of registration: 03/06/2008
• Prospective Registration: No
• Primary sponsor: JANSSEN-CILAG INTERNATIONAL NV
• Public title: Double-Blind, Placebo-Controlled, Multicenter Acute Study of Clinical Effectiveness of Nesiritide in Subjects With Decompensated Heart Failure - ASCEND-HF
• Scientific title: Double-Blind, Placebo-Controlled, Multicenter Acute Study of Clinical Effectiveness of Nesiritide in Subjects With Decompensated Heart Failure - ASCEND-HF
• Date of first enrolment: 11/04/2008
• Target sample size: 7000
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-001670-84
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Bulgaria, France, Germany, Greece, Hungary, Italy, Lithuania, Netherlands, Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
-Men or women 18 years of age or older -Hospitalized for the management of ADHF or diagnosed with ADHF within 48 hours after being hospitalized for another reason -The diagnosis of ADHF must meet the following definition: ? Dyspnea at rest or dyspnea with minimal activity (i.e., difficulty breathing at rest while sitting, or difficulty breathing while lying flat or with 1 pillow, or difficulty breathing with minimal activity such as talking, eating), AND ? At least 1 of the following signs: ? Tachypnea with respiratory rate >20 breaths per minute, OR ? Pulmonary congestion/edema with rales or crackles/crepitations at least one-third above lung base, AND ? At least 1 of the following objective measures: ? Chest x-ray with pulmonary congestion/edema, OR ? B-type natriuretic peptide >0=400 pg/mL or NT-proBNP >O=1,000 pg/mL at presentation, OR ? Pulmonary capillary wedge pressure >20 mmHg, OR ? Ejection fraction <40% measured by any modality (echocardiography, nuclear testing, cardiac MRI, ventricular angiography) within 12 months before randomization without intervening revascularization or cardiac surgery · Signed (by the subjects or their legally acceptable representatives) informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. · Signed (by the subjects or their legally acceptable representatives) informed consent form for pharmacogenomic research indicating consent or refusal to participate in the pharmacogenomic component of the study. Participation in this component is not required for participation in the clinical study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
· Hospitalized for >o=48 hours before randomization · Likely to be discharged from the hospital in 24 hours or less · At high risk for hypotension: ? Baseline SBP <100 mmHg or ? Systolic blood pressure <110 mmHg with i.v. nitroglycerin or another i.v. vasodilator used at baseline · Persistent, uncontrolled hypertension (SBP >180 mmHg) · Have any of the following cardiovascular disease parameters: ? Echocardiogram (ECG) with new ST elevation >1 mm in 2 consecutive leads ? Acute coronary syndrome as primary diagnosis ? A coronary catheterization or other coronary intervention is planned within 48 hours ? History of cardiac valvular stenosis, restrictive cardiomyopathy, hypertrophic obstructive cardiomyopathy, or pericardial tamponade ? Cardiac index >2.5 l/min/m2 or PCWP 5 times the upper limit of normal (ULN) ? Creatine kinase - MB (CK-MB) levels >3 times ULN ? BNP or NT-proBNP is within normal limits (i.e., BNP <100 pg/mL or NT-proBNP <125 pg/mL for subjects <75 years old; NT proBNP <425 pg/mL for subjects >o=75 years old) · Comorbid Diseases ? Chronic or intermittent renal support therapy (hemodialysis, ultrafiltration, or peritoneal dialysis) ? Significant chronic or acute lung disease that might interfere with the ability to interpret the dyspnea assessments (e.g., severe chronic obstructive pulmonary disease, active asthma or acute pneumonia) ? Serious comorbid disease in which the life expectancy of the subject is less than 6 months ? e.g., acute systemic infection ? sepsis, metastatic cancer or other serious illnesses ? Anemia, defined as hemoglobin <9 mg/dL (<5.6 mmol/L) or hematocrit <27% ? Active gastrointestinal bleeding · Received an experimental drug or used an experimental medical device within 30 days before randomization · Previous enrollment in a nesiritide study · Pregnant, suspected to be pregnant, or breast-feeding · Unwillingness or inability to comply with study requirements (including subjects whose cooperation is doubtful due to drug abuse or alcohol dependency)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Decompensated Hearth Failure
MedDRA version: 9.1 Level: LLT Classification code 10061216 Term: Infarction

Intervention(s)

Product Name: Nesiritide
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Nesiritide
Current Sponsor code: JNJ 27410084
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.58-
Pharmaceutical form of the placebo: Powder for infusion*
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Main Objective: The primary objective of this study is to evaluate whether treatment with nesiritide improves patient outcomes (as measured by reduction in the composite of HF rehospitalization and all-cause mortality through 30 days after randomization [Day 30]) or HF symptoms (as measured by subject self-assessed Likert dyspnea scale at 6 and 24 hours after study drug initiation) compared with placebo when each is administered in addition to other standard therapies in subjects with ADHF.

Primary end point(s): SEE OBJECTIVES

Secondary Objective: The secondary objectives of this study are to evaluate the effect of treatment with nesiritide, compared with placebo, when each is administered in addition to standard care in ADHF, in: · Improving subject self-assessed overall well-being at 6 or 24 hours after study drug initiation · Increasing the number of days alive and outside of the hospital from randomization through Day 30 · Reducing the composite of cardiovascular rehospitalization and cardiovascular mortality from randomization through Day 30

Secondary ID(s)

2007-001670-84-HU

JNJ-27410084