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


- candidate number10199
- NTR NumberNTR3006
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-jul-2011
- Secondary IDs2011-002236-92 / NL36932.075.11; METC / CCMO
- Public TitleDopamine on top of standard treatment for patients with exacerbation of Heart Failure, at home situation.
- Scientific TitleDopamine on top of standard treatment for patients with exacerbation of Heart Failure, at home situation.
- ACRONYMDo-HF
- hypothesisThis study will investigate whether 24 hour dopamine infusion reduces the need of hospital admission for patients with exacerbation heart failure.
- Healt Condition(s) or Problem(s) studiedHeart failure, Home treatment, NYHA 3-4
- Inclusion criteria1. Males or females ≥ 18 years of age;
2. Heart failure with NYHA class III-IV.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2011
- planned closingdate1-sep-2013
- Target number of participants110
- InterventionsIn 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.
- Primary outcomeUnplanned hospital admission for Heart Failure.
- Secondary outcome1. 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.
- Timepoints1. Baseline;
2. Start treatment;
3. 24 hr after start treatment;
4. End home treatment;
5. 30 days follow-up.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES J. Klijn
- CONTACT for SCIENTIFIC QUERIESDr. J.P. Ottervanger
- Sponsor/Initiator Isala Clinics Zwolle
- Funding
(Source(s) of Monetary or Material Support)
Isala Klinieken
- PublicationsN/A
- Brief summaryThis study will investigate if 24 hours of Dopamine infusion 2 g/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.
- Main changes (audit trail)
- RECORD28-jul-2011 - 2-sep-2011


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