Vascular reactivity in patients with heart failure, ex- and in vivo vasoresponsiveness

Vascular reactivity in patients with heart failure, ex- and in vivo vasoresponsiveness - VASOR

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55621

Enrollment

Registered

2015-05-22

Start date

2016-02-10

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure vasoplegia

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Group 1: - Diagnosed with heart failure in line with the European Society of Cardiology guidelines; - Left ventricular ejection fraction 50%; - Undergoing cardiac surgery on CPB.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in the phase 1 of this study: - Age 4 gamma dobutamine or dopamine), vasopression and/or mechanical support; - Patients with aortic valve insufficiency > grade 1; - Patients using a daily dosage of nitroglycerine or isosorbide dinitrate; - Patients using alpha blockers. For phase 2, patients that meet any of the following criteria will be excluded from the study: - Age 4 gamma dobutamine or dopamine) and/or vasopression; - Patients using a daily dosage of nitroglycerine or isosorbide dinitrate; - Patients using alpha blockers.

Design outcomes

Primary

Measure	Time frame
- Change in SVR after phenylephrine administration (phase 1).	—

Secondary

Measure	Time frame
In vivo (phase 1): - Systemic arterial pressure waveform morphology. - Pulse transit time. - Change in MAP, systemic arterial pressure waveform morphology and pulse transit time after phenylephrine administration. - Change in MAP, cardiac index and SVR after nitroglycerin administration. - Vasoplegia: the continuous need of vasopressors (norepinephrine 0.2 µg/ kg/min for at least 12 consecutive hours, terlipressin or methylene blue) in combination a state with a cardiac index 2,2 l/min/m2 for at least 12 consecutive hours, starting within the first 3 days postoperatively. - 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 (phase 1 and 2): - 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.	—

Measure

Time frame

In vivo (phase 1): - Systemic arterial pressure waveform morphology. - Pulse transit time. - Change in MAP, systemic arterial pressure waveform morphology and pulse transit time after phenylephrine administration. - Change in MAP, cardiac index and SVR after nitroglycerin administration. - Vasoplegia: the continuous need of vasopressors (norepinephrine *0.2 µg/ kg/min for at least 12 consecutive hours, terlipressin or methylene blue) in combination a state with a cardiac index *2,2 l/min/m2 for at least 12 consecutive hours, starting within the first 3 days postoperatively. - 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 (phase 1 and 2): - 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.

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Countries

Netherlands

Outcome results