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Vasoresponsiveness in patients with heart failure (VASOR): protocol for a prospective observational study.

ABSTRACT: BACKGROUND:Vasoplegia is a severe complication which may occur after cardiac surgery, particularly in patients with heart failure. It is a result of activation of vasodilator pathways, inactivation of vasoconstrictor pathways and the resistance to vasopressors. However, the precise etiology remains unclear. The aim of the Vasoresponsiveness in patients with heart failure (VASOR) study is to objectify and characterize the altered vasoresponsiveness in patients with heart failure, before, during and after heart failure surgery and to identify the etiological factors involved. METHODS:This is a prospective, observational study conducted at Leiden University Medical Center. Patients with and patients without heart failure undergoing cardiac surgery on cardiopulmonary bypass are enrolled. The study is divided in two inclusion phases. During phase 1, 18 patients with and 18 patients without heart failure are enrolled. The vascular reactivity in response to a vasoconstrictor (phenylephrine) and a vasodilator (nitroglycerin) is assessed in vivo on different timepoints. The response to phenylephrine is assessed on t1 (before induction), t2 (before induction, after start of cardiotropic drugs and/or vasopressors), t3 (after induction), t4 (15?min after cessation of cardiopulmonary bypass) and t5 (1?day post-operatively). The response to nitroglycerin is assessed on t1 and t5. Furthermore, a sample of pre-pericardial fat tissue, containing resistance arteries, is collected intraoperatively. The ex vivo vascular reactivity is assessed by constructing concentrations response curves to various vasoactive substances using isolated resistance arteries. Next, expression of signaling proteins and receptors is assessed using immunohistochemistry and mRNA analysis. Furthermore, the groups are compared with respect to levels of organic compounds that can influence the cardiovascular system (e.g. copeptin, (nor)epinephrine, ANP, BNP, NTproBNP, angiotensin II, cortisol, aldosterone, renin and VMA levels). During inclusion phase 2, only the ex vivo vascular reactivity test is performed in patients with (N =?12) and without heart failure (N?=?12). DISCUSSION:Understanding the difference in vascular responsiveness between patients with and without heart failure in detail, might yield therapeutic options or development of preventive strategies for vasoplegia, leading to safer surgical interventions and improvement in outcome. TRIAL REGISTRATION:The Netherlands Trial Register (NTR), NTR5647. Registered 26 January 2016.

SUBMITTER: van Vessem ME

PROVIDER: S-EPMC6868831 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Vasoresponsiveness in patients with heart failure (VASOR): protocol for a prospective observational study.

van Vessem Marieke E ME Beeres Saskia L M A SLMA de Wilde Rob B P RBP de Vries René R Berendsen Remco R RR de Jonge Evert E Danser A H Jan AHJ Klautz Robert J M RJM Schalij Martin J MJ Palmen Meindert M

Journal of cardiothoracic surgery 20191121 1

<h4>Background</h4>Vasoplegia is a severe complication which may occur after cardiac surgery, particularly in patients with heart failure. It is a result of activation of vasodilator pathways, inactivation of vasoconstrictor pathways and the resistance to vasopressors. However, the precise etiology remains unclear. The aim of the Vasoresponsiveness in patients with heart failure (VASOR) study is to objectify and characterize the altered vasoresponsiveness in patients with heart failure, before, ...[more]

PMID: 31752946

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Project description:BackgroundThe burden of heart failure is growing in sub-Saharan Africa, but there is a dearth of data characterizing care and outcomes of heart failure patients in the region, particularly in emergency department settings.MethodsIn a prospective observational study, adult patients presenting with shortness of breath or chest pain to an emergency department in northern Tanzania were consecutively enrolled. Participants with a physician-documented clinical diagnosis of heart failure were included in the present analysis. Standardized questionnaires regarding medical history and medication use were administered at enrollment, and treatments given in the emergency department were recorded. Thirty days after enrollment, a follow-up questionnaire was administered to assess mortality and medication use. Multivariate logistic regression was performed to identify baseline predictors of thirty-day mortality.ResultsOf 1020 enrolled participants enrolled from August 2018 through October 2019, 267 patients (26.2%) were diagnosed with heart failure. Of these, 139 (52.1%) reported a prior history of heart failure, 168 (62.9%) had self-reported history of hypertension, and 186 (69.7%) had NYHA Class III or IV heart failure. At baseline, 40 (15.0%) reported taking a diuretic and 67 (25.1%) reported taking any antihypertensive. Thirty days following presentation, 63 (25.4%) participants diagnosed with heart failure had died. Of 185 surviving participants, 16 (8.6%) reported taking a diuretic, 24 (13.0%) reported taking an antihypertensive, and 26 (14.1%) were rehospitalized. Multivariate predictors of thirty-day mortality included self-reported hypertension (OR = 0.42, 95% CI: 0.21-0.86], p = 0.017) and symptomatic leg swelling at presentation (OR = 2.69, 95% CI: 1.35-5.56, p = 0.006).ConclusionIn a northern Tanzanian emergency department, heart failure is a common clinical diagnosis, but uptake of evidence-based outpatient therapies is poor and thirty-day mortality is high. Interventions are needed to improve care and outcomes for heart failure patients in the emergency department setting.

Project description:BackgroundThough breast cancer remains a major health problem, there is a lack of information on health care provided to patients with this disease and associated costs. In addition, there is a need to update and validate risk stratification tools in Spain. Our purpose is to evaluate the health services provided for breast cancer in Spain, from screening and diagnosis to treatment and prognosis.MethodsProspective cohort study involving 13 hospitals in Spain with a follow-up period of up to 5 years after diagnostic biopsy. Eligibility criteria: Patients diagnosed with breast cancer between April 2013 and May 2015 that have consented to participate in the study.Data collectionData will be collected on the following: pre-intervention medical history, biological, clinical, and sociodemographic characteristics, mode of cancer detection, hospital admission, treatment, and outcomes up to 5 years after initial treatment. Questionnaires about quality of life (EuroQoL EQ-5D-5 L, the European Organization For Research And Treatment Of Cancer Core Quality Of Life Questionnaire EORTC QLQ-C30 join to the specific breast cancer module (QLQ-BR23), as well as Hospital Anxiety and Depression Scale were completed by the patients before the beginning of the initial treatment and at the end of follow-up period, 2 years later. The end-points of the study were changes in health-related quality of life, recurrence, complications and readmissions at 2 and 5 years after initial treatment.Statistical analysisDescriptive statistics will be calculated and multivariate models will be used where appropriate to adjust for potential confounders. In order to create and validate a prediction model, split validation and bootstrapping will be performed. Cost analysis will be carried out from the perspective of a national health system.DiscussionThe results of this coordinated project are expected to generate scientifically valid and clinically and socially important information to inform the decision-making of managers and the authorities responsible for ensuring equality in care processes as well in health outcomes. For clinicians, clinical prediction rules will be developed which are expected to serve as the basis for the development of software applications.Trial registrationNCT02439554 . Date of registration: May 8, 2015 (retrospectively registered) .

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Vasoresponsiveness in patients with heart failure (VASOR): protocol for a prospective observational study.

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Vasoresponsiveness in patients with heart failure (VASOR): protocol for a prospective observational study.

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