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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002236-92-NL

Enrollment

110

Registered

2011-06-14

Start date

2011-08-11

Completion date

Unknown

Last updated

2018-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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 Class

Interventions

Trade Name: Dopamine HCl Product Name: Dopamine HCl Product Code: RVG 08673 Pharmaceutical Form: Infusion

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: • Cardiogenic shock • Tachycardia, heart rate > 100 bpm • Indication for hospitalization • Severe aortic valve stenosis • Severe hepatic or renal disease • Patients with acute coronary syndromes • Previous participation in the study • Life expectancy of < 1 year • Absolute contra indication for the use of Dopamine • Women of child-bearing potential • Unable to provide informed consent

Design outcomes

Primary

Measure	Time frame
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;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 ;Primary end point(s): Unplanned hospital admission for Heart Failure;Timepoint(s) of evaluation of this end point: During home treatment till 30 day's follow-up	—

Measure

Time frame

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;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 ;Primary end point(s): Unplanned hospital admission for Heart Failure;Timepoint(s) of evaluation of this end point: During home treatment till 30 day's follow-up

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Netherlands

Contacts

Public ContactManager CRO

Diagram B.V.

j.klijn@diagram-zwolle.nl+31384262999

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026