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Vascular reactivity in patients with heart failure


- candidate number23653
- NTR NumberNTR5647
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-jan-2016
- Secondary IDsNL51125.058.14 
- Public TitleVascular reactivity in patients with heart failure
- Scientific TitleVascular reactivity in patients with heart failure Ex- and in vivo vasoresponsiveness
- ACRONYMVASOR
- hypothesis
- Healt Condition(s) or Problem(s) studiedHeart failure
- Inclusion criteriaGroup 1:
- Diagnosed with heart failure in line with the European Society of Cardiology (ESC) guidelines (McMurray et al., 2012);
- LVEF <35%.
- Undergoing cardiac surgery on CPB.

Group 2:
- Not diagnosed with heart failure;
- LVEF >50%.
- Undergoing cardiac surgery on CPB.
- Exclusion criteria- Age <18 years;
- Incapacitated adults;
- Emergency operation;
- Patients in need of moderate of high dosages of intravenous inotropic support (>4 gamma dobutamine or dopamine), vasopression and/or mechanical support.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-feb-2016
- planned closingdate1-feb-2017
- Target number of participants36
- Interventions- Phenylephrine challenge
- Vasodilation test
- Primary outcome- Change in SVR after phenylephrine administration
- Secondary outcomeIn vivo
- Change in mean arterial pressure (MAP) after phenylephrine administration.
- Change in MAP, SVR and CI after nitroglycerin administration.
- Vasoplegia
- Copeptin, norepinephrine, epinephrine, atrial natriuretic peptide (ANP), brain natriuretic peptide (BNP), N-terminal prohormone of BNP (NTproBNP), angiotensin II, cortisol, aldosterone, renin and vanillylmandelic acid (VMA) levels

Ex vivo
- Change in vessel diameter in response to vasoactive drugs.
- Activated signalling proteins which are associated with vasoresponsiveness.
- Receptors (quantity and function) which are associated with vasoresponsiveness.
- TimepointsThe phenylephrine challenge will be performed:
1. Before induction, before start medication (dobutamine, milrinone, noradrenalin)
2. Before induction, after start medication
3. After induction
4. After CPB, before emergence
5. On day 1 postoperative

The vasodilation test will be performed at the beginning of the surgery after placement of the arterial catheter and 1 day post-operatively.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Marieke E. van Vessem
- CONTACT for SCIENTIFIC QUERIES Marieke E. van Vessem
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD26-jan-2016 - 11-mrt-2016


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