Heart Decompensation, Heart Failure
Conditions
Keywords
Heart Failure
Brief summary
A placebo controlled, double-blind and randomized study to assess different doses of a new drug (BAY58-2667) given intravenously, to evaluate if it is safe and can help to improve the well-being of patients with acute decompensated heart failure.
Interventions
Infusion of 150 µg/h during 48h.
DRUGPlacebo
Infusion during 48h
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and non-pregnant, non-lactating female subjects, age \>/= 18 years of age; or women without childbearing potential defined as postmenopausal women aged 55 years or older, women with bilateral tubal ligation, women with bilateral ovarectomy, and women with a hysterectomy * Subjects must have the clinical diagnosis of congestive heart failure (CHF) made at least three months prior to enrollment * Subjects must experience worsening of both of the symptoms below leading to hospitalization at the time of entry into the study: dyspnea and clinical evidence of volume overload
Exclusion criteria
* Acute de-novo heart failure * Acute myocardial infarction and/or myocardial infarction within 30 days * Valvular heart disease requiring surgical intervention during the course of the study * Heart failure due to or associated with uncorrected primary valvular disease, malfunctioning artificial heart valve, or uncorrected congenital heart disease * Primary hypertrophic cardiomyopathy * Acute inflammatory heart disease, eg, acute myocarditis * Unstable angina requiring angiography
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dyspnea VAS (using a visual analogue scale) | 8 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall health status assessment (EQ-5D) | up to follow-up (30 - 35 days) | — |
| Changes in the dyspnea VAS at other time points | Up to follow up visit | — |
| Dyspnea assessment through Likert scale | Up to follow up visit | — |
| Dyspnea assessment (Likert Scale) | up to follow-up (30 - 35 days) | — |
| Global clinical assessment by the physician | At 8, 24, and 48 hours | — |
| Change in concomitant medications | During the treatment | — |
| Safety variables | Up to end of study | Frequency of TEAEs (AEs were considered to be treatment emergent if they started after the start of sthe study drug infusion to up to 2 calendar days after the end of the study drug infusion); treatment-emergent serious adverse events (SAEs); deaths; evaluation of renal and cardiac function; Change in heart rate; Change in systolic and diastolic blood pressure; Laboratory parameters (including parameters related to hematology, clinical chemistry, urinalysis, and biomarkers); ECG assessment |
| Overall health status assessment through EQ-5D Health Questionnaire | Up to the follow-up visit | — |
Countries
Canada, Czechia, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Poland, South Africa, South Korea, Spain, United Kingdom, United States
Outcome results
None listed