The primary objective of this randomized, open label single centre trial is to 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…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Unplanned hospital admission for Heart Failure
Secondary outcome
• 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
Galectin-3 value
Background summary
Acute HF is defined as gradual or rapid changes in signs and symptoms of HF
that require urgent therapy. 3 In acute decompensated heart failure, the
immediate goal is to re-establish adequate perfusion and oxygen delivery to end
organs. 4 Initial therapy of acute decomposated HF usually includes combination
of an vasodilator such as nitroglycerine, diuretics, oxygeen supply and
morfine. Inotropics, like dobutamine en dopamine, milrinone are usually used
when the asbove mentiond treatment is not sufficient. 2
The current study is a prospective, randomized single centre, open label
trial. In this trial patients will be included that not need to be hospitalized
for the decompensated heart failure but can be recompensted with additional
diuretics intra venous at home setting. The home treatent will be accompanied
by the specialized nurses of the Chance@home team of the Isala klinieken. The
patients that are randomized to Dopamine will receive 24 hours Dopamine on top
of the standard treatement.
Study objective
The primary objective of this randomized, open label single centre trial is to
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.
Study design
Single centre, randomized, open study
Intervention
Patients who are randomized to Dopamine will get a Dopamine infusion during 24
hours +- 6 hr.
Study burden and risks
Minimal burden due to the 24 hours Dopamine infusion and blood draw of 2 extra
blood tubes (during regular blood taking)
Groot Wezenland 20
8011JW Zwolle
NL
Groot Wezenland 20
8011JW Zwolle
NL
Listed location countries
Age
Inclusion criteria
Exacerbation heart failure with NYHA class III-IV
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2011-002236-92-NL |
CCMO | NL36932.075.11 |