Gender Specific Registry in Subjects Hospitalized With Heart Failure in Santiago( GENESIS Registry): Pilot Heart Failure Registry Looking for Sex Analysis
Gender Specific Registry in Subjects Hospitalized With Heart Failure in Santiago( GENESIS Registry): Pilot Heart Failure Registry Looking for Sex Analysis
This is an observational registry, which main purpose is to assess sex-related differences in heart failure (HF) presentation, management, and prognosis in patients admitted to a hospital with a certain diagnosis of HF. The diagnosis will be based on European Society of Cardiology (ESC) definition of HF ( clinical syndrome characterized by symptoms and/or signs caused by a cardiac abnormality, that results in elevated intracardiac pressure and/or inadequate output at rest or exercise ). The sample will be obtained prospectively by recruitment of patients of two hospitals of Santiago de Chile.
-Methods Study design and participants
Observational and prospective registry led by the Chilean Society of Cardiology and Cardiac Surgery Foundation (Fundación SOCHICAR), that will be held at hospitals of different communes in urban Santiago. This project will incorporate two hospitals in a period of one year.
The hospital selection will be based on the purpose of having the most clinical information of the patient regarding his/her cardiac condition. Both participating centers must have coronary units, cardiac surgery, and interventional cardiology. Also, both hospitals must have medical teams with expertise in cardiac imaging, and have access to a local laboratory that performs biomarkers (i.e. NT-terminal pro-brain natriuretic peptide (NTpro-BNP), usTroponin).
The registry consists of a descriptive cross-sectional survey. Thereby, this study is a one-time assessment, with no visit schedule.
Ethics consideration The registry must be approved by the Ethics committee of each clinical center, or in case of not having one, by the Metropolitan Region Ethics Committee respective of each area. Each patient must be informed about the study's rationale and his/ her potential willingness of participation. Written informed consent will be obtained from all participants before data collection.
Study population: approximately 500 patients hospitalized in the two recruiting centers during one year who comply with all the eligible criteria and without exclusion criteria.
-Data source Data will be obtained from the medical files, and will be collected prospectively by a center coordinator using a tablet electronic survey. The survey will be created using a Google form questionnaire, easy to fill in and register.
The confidentiality of the patient will be protect, using patients´ identification based on their initials (first name - first last name - second last name) plus an odd or even sequential number according to the belonging hospital (ie: Mary Jo Salas Gómez MSG1).
The registry will include: demographic, cardiovascular (CV) risk factors, medical history, comorbidities, blood biochemical parameters, diagnostic imaging determinants, treatment, and outcomes data.
The information about Patient Healthe Questionnaire (PHQ) 9 questionnaire will be answered confidentially by the patient in the tablet
With respect to data limitation, the investigators will be conditioned by the information available in the medical file, and the laboratory and imaging exams requested by the head and referral physicians.
STATISTICAL METHODS Sample size and statistical power; precision assessment The sample size was estimated considering the data reported in one of the largest trials that have addressed sex differences in heart failure (HF-Action Trial by Sex, Am Heart J. 2009 Oct; 158(40): S16-S23.) 20. This trial shows that the prevalence of Heart Failure of ischemic cause (one of the main objectives of our trial) was 59% in males and 32% in females.
The calculation of the sample size was carried out to find significant differences between the prevalence of heart failure from ischemic etiology in female patients consecutively hospitalized compared to male, based on Chi-square test for comparison of proportions, considering a significance of 95% and power of 90 %. Therefore,the investigators will included in our study approximately 500 patients knowing that to get a significance of 95 % and a power of 90% the investigators must recruit at least 156 patients (52 females and 104 males) considering 2:1 male-to-female proportion. In order to perform a stratified analysis, the investigators estimated that the lowest sample size for each center should be 78 patients.( with 2:1 male -to - female proportion)
-Statistical considerations
Data management:
The data completeness and accuracy will be addressed through out-of-range alerts and control of unreported data. The nurse coordinator will verify the completeness and accuracy of the information and send the respective queries on a daily basis.
Missing data will be addressed according to covariate. Given the observational data collection of the registry, few data could be missing. These data will be addressed according the kind of covariate. In general, a multiple imputation strategy will be performed.
All the data will be electronically registered in an Excel file. Privileges will be conferred according the role of the personnel on the study. The Principal Investigators will have access to all data.
-Statistical Analyses: All the important covariates will be recorded. Specifically, information on patients' characteristics, demographics, basal functional capacity, complete blood test analyses, EKG, echocardiography, and relevant clinical information will be registered at baseline according to the protocol of each center. For analyses purposes, the prevalence of HF phenotype (ie. with preserved, mildly and reduced ejection fraction), and etiology (ie. ischemic and non ischemic) will be considered as primary outcomes.
All the variables will be tested for normality using Shapiro-Wilk test. The investigatorswill compare the percentages of heart failure with preserved ejection fraction (HFpEF), with mildly reduced ejection fraction (HFmrEF) and reduced ejection fraction (HFrEF) phenotypes according to gender, using Chi-square test. Also, the investigators will compare the percentages of HF etiology (ie. Ischemic and non ischemic) according to gender, using Chi-square test. Moreover, T-test statistics will be used according the variable.
The demographic variables that will be incorporated are:
The medical history that will be asked are:
HF Characteristics.
HF cause: ischemic, non ischemic and hypertensive.
Decompensating HF clinical factors.
Precipitating clinical factors.
Questionnaires:
Laboratory Determinations:
Imaging Determinations
Echocardiography:
Thoracic Radiography (RX)
Magnetic cardiac resonance
Coronary angiogram
Treatment
1- Pharmacological: names and daily doses
B -blockers (total daily dose): bisoprolol, metoprolol,carvedilol, nebivolol, others
Angiotensin converting enzyme (ACE) inhibitors (total daily dose): enalapril, ramipril, captopril, perindopril, lisinopril, others/ Angiotensin 2 Receptors blockers (total daily dose): losartan, valsartan, telmisartan, candesartan, Olmesartan, others
Angiotensin receptor/neprilysin inhibitor (ARNI) (total daily dose): Sacubitril / Valsartan
Mineralocorticoid antagonist receptors (total daily dose): spironolactone /eplerenone/finerenone
Sodium glucose cotransporter 2 (SGLT 2) Inhibitors (total daily dose): dapagliflozin, empagliflozin.
Diuretics (total daily dose): furosemide (Intravenous /oral) metolazone, hydrochlorothiazide,chlortalidone, indapamide, others
Vericiguat
Ivabradine
Digoxin
Calcium Channel Blockers: amlodipine, others
Nitrites: Intravenous nitroglycerine/ Isosorbide dinitrate / Isosorbide mononitrate
Other vasodilators: hydralazine
Statins: atorvastatin, rosuvastatin, simvastatin, others
Ezetimibe
Anti diabetic drugs: metformin, glibenclamide, glipizide, insulin, dipeptidyl peptidase 4 (DPP4) such as sitagliptin, saxagliptin, linagliptin, vildagliptin and glucagon like peptide 1 (GLP1) analogues such as semaglutide, liraglutide, dulaglutide.
Anticoagulants: vitamin K antagonists (VKA), direct oral anticoagulants (OACs): apixaban, rivaroxaban, dabigatran.
Platelet inhibitors: aspirin, clopidogrel, ticagrelor.
Intravenous Iron Therapy
Intravenous Inotropic therapy: dobutamine, milrinone, levosimendan.
2. Non pharmacological
Cardiovascular Rehabilitation (Yes /No)
Devices: Pacemaker / Cardiac resynchronization therapy/ (ICD) implantable cardioverter-defibrillator.
Inclusion criteria:
Exclusion criteria:
pao.varleta@gmail.com+569 95390767
macevedo@ucchristus.cl+569 92282617