|- candidate number||25448|
|- NTR Number||NTR6143|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-okt-2016|
|- Secondary IDs||MEC-2016-475 |
|- Public Title||Evaluation of a temporary pump in patients with decompensated heart failure|
|- Scientific Title||Evaluation of the intra-aortic balloon pump in patients with decompensated heart failure|
|- hypothesis||In severe heart failure, the heart¡¯s pumping power is weak, leading to fluid retention and hospital admission of the affected patient. This project will investigate if a temporary pump (intra-aortic balloon pump, IABP) in the aorta will treat fluid overload so that patients are bridged faster towards recovery or to surgical assist device implantation.|
|- Healt Condition(s) or Problem(s) studied||Cardiogenic shock|
|- Inclusion criteria||CONGESTIVE HEART FAILURE (FIRST EPISODE (¡°DE NOVO¡±) OR WORSENING OF CHRONIC HEART FAILURE) WITH THE FOLLOWING CHARACTERISTICS: |
BLOOD PRESSURE Systolic <100 mm Hg
PHYSICAL EXAMINATION Fluid retention (elevated central venous pressure, palpable liver, edema)
ECHO At least moderate tricuspid regurgitation and/or mitral valve regurgitation. Dilated inferior caval vein.
INVASIVE MEASUREMENTS PCWP >15 mmHg; CVP >12 mmHg; SvO2 <55%
NT-PROBNP >200 pg/mL
FLUID BALANCE Neutral or positive despite fluid restriction (1.5L/24h) and administration of high dosages of intravenous diuretics*
TOGETHER WITH: Dysfunction of at least 1 other organ#
PCWP, pulmonary capillary wedge pressure; CVP, central venous pressure.
* Bolus dosage (equal to) 80 mg intravenous furosemide followed by total intravenous dosage equal to total daily loop diuretic dose in furosemide equivalents and (if necessary) doubled, for at least 12h.
# Lung: extra oxygen supplementation, kidney: creatinine clearance <50 mL/min, liver enzymes ¡İ2x upper limit of normal, or lactate levels ¡İ2.0 mmol/L.
|- Exclusion criteria||- Significant aortic valve regurgitation.|
- Absent common femoral artery pulsation.
- Acute myocardial infarction <7 days before inclusion.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2017|
|- planned closingdate||1-jan-2020|
|- Target number of participants||30|
|- Interventions||Intra-aortic balloon pump vs inotropic therapy|
|- Primary outcome||Delta SvO2 (T3h minus baseline T0h (=mean of two baseline measurements with interval 15 minutes)).|
|- Secondary outcome||- Cardiac power output at T=24h (absolute and change vs baseline).|
- NT-proBNP levels at T=48h (absolute and change vs baseline).
- Negative fluid balance of at least 1L at T48h.
- Patient Global Assessment: Dyspnea Severity Score or Visual Analogue Scale at T=48h (absolute and change vs baseline).
- Escalation of therapy.
- Duration of hospital stay.
- Major adverse cardiac events (MACE, = combined endpoint of escalation of therapy, death, heart failure rehospitalization, TIA/stroke). To assess at 30 days and 3 months.
|- Timepoints||T=0h, T=3h, T=12h, T=24h, T=48h, T=72h.
At T=48h, a crossover will be performed in clinical non-responders as defined by protocol.|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Dr. C.A. den Uil|
|- CONTACT for SCIENTIFIC QUERIES||Dr. C.A. den Uil|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center|
|- Brief summary||Rationale: In severe heart failure, the heart¡¯s pumping power is weak, leading to fluid retention and hospital admission of the affected patient. This project will investigate if a temporary pump (intra-aortic balloon pump, IABP) in the aorta will treat fluid overload so that patients are bridged faster towards recovery or to surgical assist device implantation.|
Objective: Evaluation of the benefit of IABP counterpulsation in patients with diuretic-resistant congestive heart failure.
To lower the burden of disease/improve symptoms, to shorten duration of stay in the hospital, to improve the function of other organs than the heart, and to bridge patients faster to final treatment (medical vs. LVAD vs. transplantation vs. palliative care).
To create evidence based knowledge and gain better understanding of the disease, resulting in tailor-made treatment.
Study design: Open-label randomized controlled parallel, partial cross-over, study in patients with diuretic-resistant congestive heart failure.
Study population: Patients with congestive heart failure, refractory to treatment with high dosages of intravenous diuretics.
Intervention (if applicable): Patients will be randomized to IABP (without inotrope, group I) or inotrope (without IABP, group II).
Main study parameters/endpoints: Delta SvO2 at T=3h.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients in evident heart failure refractory to high-dose diuretic therapy have a poor prognosis. Escalation therapy will be given by either inotropic therapy (carrying the risks of arrhythmias) or an IABP (carrying the risks of access site and remote complications, <1%). Both treatment options have been successfully applied to save patients.
|- Main changes (audit trail)|
|- RECORD||24-okt-2016 - 22-jan-2017|