Heart Failure Clinical Trial
— GENESISOfficial title:
Gender Specific Registry in Subjects Hospitalized With Heart Failure in Santiago( GENESIS Registry): Pilot Heart Failure Registry Looking for Sex Analysis
NCT number | NCT05960968 |
Other study ID # | FSoChiCar-HF01 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 11, 2023 |
Est. completion date | August 2025 |
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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | August 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria: - Patient with = 18 years old - Signed informed consent - Admitted to the hospital with a : - 1) diagnosis of acute HF as the leading cause of admission, and in which a CV therapy is needed and prescribed (ie. diuretic, vasodilator, inotropic, device), or - 2) diagnosis of chronic HF is established during the patient hospitalization based on clinical, biochemical and/or imaging studies, and in which cardiovascular therapy is needed and prescribed (ie. diuretic, vasodilator, inotropic, device ) during the hospitalization. Exclusion criteria: - The patient presents a Covid 19 acute infection and/ or severe acute respiratory syndrome (SARS) -CoV 2 pneumonia is confirmed - The patient presents a psychiatric decompensated disorder and/or a cognitive impairment which preclude assessment of this survey. |
Country | Name | City | State |
---|---|---|---|
Chile | Paola Varleta | Santiago | Region Metropolitana |
Lead Sponsor | Collaborator |
---|---|
Fundacion de la Sociedad Chilena de Cardiologia y Cirugia Cardiovascular | Hospital Dipreca, Pontificia Universidad Catolica de Chile |
Chile,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | To determine the presence of depressive symptoms and depression in hospitalized HF patients by a pre-specified sex analysis. | The outcome measure will be assessed with the Patient Health Questionnaire (PHQ)-9 , which is a validated questionnaire to measure depressive symptoms. Mild-to-moderate depressive symptoms (10 to 19 points) and major depression (= 20 points). The more points , the closer to the diagnosis of depression. | 12 months | |
Other | To determine if frailty prevalence is different in hospitalized HF patients by sex pre-specified analysis. | The outcome measure will be evaluated by the Simplle FRAIL questionnaire, consisting of 5 questiones. 3 or greater = frailty; 1 or 2 = prefrail | 12 months | |
Primary | The prevalence of HF phenotype( preserved, mildly reduced or reduced) by sex | The outcome measure will be the prevalence (% of the study population) according to the HF phenotype (preserved, mildly reduced or reduced). The working definition of HF phenotypes will be in accordance to 2021 ESC guidelines of HF, based on the followimg criteria: a. clinical (shortness of breath and/or fatigue and /or ankle swelling, and/or jugular venous distention and /or rales at the lung examination),b. echocardiography: measurement of ejection fraction by transthoracic echocardiogram: HF with Reduced ejection fraction- HFrEF-(< 40%), HF with midly reduced ejection fraction-HFmrEF- (= 40 to 49 %) and Preserved Ejection Fraction- HFpEF- (= 50%), this last one associated with NT pro BNP (= 125 pg/ml in sinus rhythm. | 12 months | |
Secondary | Prevalence of HF etiologies (ischemic, non ischemic or hypertensive) by sex. | The outcome measure will be the prevalence of HF etiology (ischemic, non ischemic, and hypertensive). With regard to ischemic etiology, the study definition will be based on a definite diagnosis of ischemic heart disease (epicardial coronary artery stenosis greater than 50%, and /or previous myocardial infarction, and/or previous revascularization (CABG or PCI) or a positive imaging stress test, such as echo, nuclear, or cardiac magnetic resonance (CMR) . Hypertensive cardiomyopathy will be defined for HF with reduced , mild reduced or preserved eyection fraction only if long standing hypertension (at least 20 years) , and with cardiac structural changes suitable with hypertensive etiology: presence of diastolic dysfunction, and /or LV hypertrophy. | 12 months | |
Secondary | To evaluate socioeconomic level in the study population (patients hospitalized with HF) by sex specific analysis. | To evaluate socioeconomic level in this cohort. The outcome measure will be based on the household average family income per capita based on the Chilean National Socioeconomic Characterization (CASEN) Survey 2020 (low from ~276 to 340 US dollars; middle: ~345 to 438 US dollars, and high: ~459 to 2763 US dollars). The low socioeconomic level represents the minimum wage per capita in Chile in the study period | 12 months | |
Secondary | To evaluate educational level in the study population ( patients hospitalized with HF) by sex specific analysis. | To evaluate educational level in this cohort. The outcome measure will be based on the years of education. | 12 months | |
Secondary | To assess the prevalence of comorbidities associated with HF by sex-specific analysis | The comorbidities that will be analysed wil be: diabetes ( having a medical diagnosis of diabetes withor without pharmacological treatment or having fastingglucose =126 mg/dL), elderly (= 60 years of age, chronic renal failure (CKD) 4 or 5 phase, anemia ( hemoglobin value of less than 13.5 gm/dl in a man or less than 12.0 gm/dl in a woman), obesity (= 30 mg /kg 2 and Chronic obstructive pulmonary disease (COPD) based on the 2023 Global Initiative for Chronic Obstructive Lung Disease report last definition, which defines COPD as "a heterogeneous lung condition characterized by chronic respiratory symptoms (dyspnea, cough, expectoration, exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and/or alveoli (emphysema) that cause persistent, often progressive, airflow obstruction." | 12 months | |
Secondary | To determine the main decompensating risk factors in HF patients by sex-specific analysis | The prevalence of decompensating risk factors that wil be assessed will be: medication and diet non-adherence, atrial fibrillation, infections, acute renal failure and acute coronary syndromes | 12 months |
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