No registrations found.
ID
Source
Brief title
Health condition
Heart failure, home treatment, NYHA 3-4
Hartfalen, thuisbehandeling, NYHA 3-4
Sponsors and support
Groot wezenland 20
8011 JW Zwolle
The Netherlands
Groot wezenland 20
8011 JW Zwolle
The Netherlands
Intervention
Outcome measures
Primary outcome
Unplanned hospital admission for Heart Failure.
Secondary outcome
1. Weight reduction;
2. Renal impairment (elevation in serum creatinine by more than 40 micromoles/L);
3. Pro-BNP level;
4. Absolute need of inotropicum;
5. Occurrence of arrhythmia, hypertension, anginal pain, nausea, vomiting, and headache;
6. Pharmacy-economical efficiency of the treatment.
Background summary
This study will investigate if 24 hours of Dopamine infusion 2 µg/kg/min at home situation, on top of standard treatment, can increase successful home treatments.
In patients presenting in hospital with exacerbation of heart failure (NYHA III-IV) that are candidate for home treatment.
Study objective
This study will investigate whether 24 hour dopamine infusion reduces the need of hospital admission for patients with exacerbation heart failure.
Study design
1. Baseline;
2. Start treatment;
3. 24 hr after start treatment;
4. End home treatment;
5. 30 days follow-up.
Intervention
In this trial patients will be included that don't need to be hospitalized for the decompensated heart failure but can be recompensated with additional diuretics intra venous at home setting. The home treatment 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 treatment.
Dokter Stolteweg 96
J. Klijn
Dokter Stolteweg 96
Zwolle 8025 AZ
The Netherlands
+31 (0)38 4262997
j.klijn@diagram-zwolle.nl
Dokter Stolteweg 96
J. Klijn
Dokter Stolteweg 96
Zwolle 8025 AZ
The Netherlands
+31 (0)38 4262997
j.klijn@diagram-zwolle.nl
Inclusion criteria
1. Males or females ≥ 18 years of age;
2. Heart failure with NYHA class III-IV.
Exclusion criteria
1. Cardiogenic shock;
2. Tachycardia, heart rate > 100 bpm;
3. Indication for hospitalization;
4. Severe aortic valve stenosis;
5. Severe hepatic or renal disease;
6. Patients with acute coronary syndromes;
7. Previous participation in the study;
8. Life expectancy of < 1 year;
9. Absolute contra indication for the use of Dopamine;
10. Women of child-bearing potential;
11. Unable to provide informed consent.
Design
Recruitment
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 |
---|---|
NTR-new | NL2863 |
NTR-old | NTR3006 |
Other | METC / CCMO : 2011-002236-92 / NL36932.075.11; |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |