Dopamine on top of standard treatment for patients with exacerbation of Heart Failure, at home situation

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2011
INTERVENTION: Trade Name: Dopamine HCl Product Name: Dopamine HCl Product Code: RVG 08673 Pharmaceutical Form: Infusion CONDITION: exacerbation of Heart Failure treated at home ; MedDRA version: 13.1 Level: LLT Classification code 10000803 Term: Acute heart failure System Organ Class: 10007541 ‐ Cardiac disorders ; MedDRA version: 13.1 Level: LLT Classification code 10019284 Term: Heart failure, congestive System Organ Class: 10007541 ‐ Cardiac disorders ; MedDRA version: 13.1 Level: LLT Classification code 10024106 Term: Left heart failure System Organ Class: 10007541 ‐ Cardiac disorders ; MedDRA version: 13.1 Level: LLT Classification code 10064082 Term: Heart failure NYHA class IV System Organ Class: 10007541 ‐ Cardiac disorders ; MedDRA version: 13.1 Level: LLT Classification code 10008908 Term: Chronic heart failure System Organ Class: 10007541 ‐ Cardiac disorders ; MedDRA version: 13.1 Level: LLT Classification code 10064653 Term: Acute decompensated heart failure System Organ Class: 10007541 ‐ Cardiac disorders Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: Main Objective: compare dopamine versus no dopamine on top of standard treatment in patients with exacerbation of severe heart failure (NYHA class III‐IV) in home situation. This study will investigate whether 24 hour dopamine infusion reduces the need of hospital admission for patients with exacerbation heart failure Primary end point(s): Unplanned hospital admission for Heart Failure Secondary Objective: Secondary endpoints; • Weight reduction; • Renal impairment (elevation in serum creatinine by more than 40 micromoles/L); • Pro‐BNP level; • Absolute need of inotropicum; • Occurrence of arrhythmia, hypertension, anginal pain, nausea, vomiting, and headache; • Pharmacy‐economical efficiency of the treatment; Timepoint(s) of evaluation of this end point: During home treatment till 30 day's follow‐up SECONDARY OUTCOME: Secondary end point(s): • Weight reduction ; • Renal impairment (elevation in serum creatinine by more than 40 micromoles/L) ; • Pro‐BNP level ; • Absolute need of inotropicum ; • Occurrence of arrhythmia, hypertension, anginal pain, nausea, vomiting, and headache ; • Pharmacy‐economical efficiency of the treatment ; Timepoint(s) of evaluation of this end point: During home treatment till 30 day's follow‐up INCLUSION CRITERIA: Exacerbation heart failure with NYHA class III‐IV 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Epistemonikos ID: c80c68a616df3db002d6f1bf1493528120272656
First added on: Aug 22, 2024