Gender Specific Registry in Subjects Hospitalized With Heart Failure in Santiago

NCT05960968 | Recruiting

• 1 other identifier: FSoChiCar-HF01
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure

Keywords

Heart Failure,; Gender; Women; Epidemiology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Prevalence of HF etiologies (ischemic, non ischemic or hypertensive) by sex.

  12 months

• To evaluate socioeconomic level in the study population (patients hospitalized with HF) by sex specific analysis.

  12 months

• To evaluate educational level in the study population ( patients hospitalized with HF) by sex specific analysis.

  12 months

• To assess the prevalence of comorbidities associated with HF by sex-specific analysis

  12 months

• To determine the main decompensating risk factors in HF patients by sex-specific analysis

  12 months

Other Outcomes (2)

• To determine the presence of depressive symptoms and depression in hospitalized HF patients by a pre-specified sex analysis.

  12 months

• To determine if frailty prevalence is different in hospitalized HF patients by sex pre-specified analysis.

  12 months

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Eligibility is based on self representation of gender identity
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population must comply with the definition of Heart Failure according to 2021 European Society of Cardiology (ESC) Guidelines. A practical definition of HF will be shortness of breath and/or fatigue and /or ankle swelling, and/or jugular venous distention and /or rales at the lung examination, with an ejection fraction by echocardiography \>= 40% ( HF with Reduced ejection fraction- HFrEF) and /or greater than 40% (41 to 49 % represents HF with midly reduced ejection fraction-HFmrEF and \>= 50% Preserved Eyection Fraction-HFpEF); this last one associated with pro BNP \> 125 pg/ml in sinusal rhythm.

You may qualify if:

• Patient with ≥ 18 years old
• Signed informed consent
• Admitted to the hospital with a :
• \) 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
• \) 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion de la Sociedad Chilena de Cardiologia y Cirugia Cardiovascular: lead
• Hospital Dipreca: collaborator
• Pontificia Universidad Catolica de Chile: collaborator

Study Sites (1)

Paola Varleta

Santiago, Santiago Metropolitan, 7700034, Chile

RECRUITING

Related Publications (19)

• McCullough PA, Philbin EF, Spertus JA, Kaatz S, Sandberg KR, Weaver WD; Resource Utilization Among Congestive Heart Failure (REACH) Study. Confirmation of a heart failure epidemic: findings from the Resource Utilization Among Congestive Heart Failure (REACH) study. J Am Coll Cardiol. 2002 Jan 2;39(1):60-9. doi: 10.1016/s0735-1097(01)01700-4.

  PMID: 11755288 BACKGROUND

• Braunwald E. Heart failure. JACC Heart Fail. 2013 Feb;1(1):1-20. doi: 10.1016/j.jchf.2012.10.002. Epub 2013 Feb 4.

  PMID: 24621794 BACKGROUND

• Solomon SD, Dobson J, Pocock S, Skali H, McMurray JJ, Granger CB, Yusuf S, Swedberg K, Young JB, Michelson EL, Pfeffer MA; Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity (CHARM) Investigators. Influence of nonfatal hospitalization for heart failure on subsequent mortality in patients with chronic heart failure. Circulation. 2007 Sep 25;116(13):1482-7. doi: 10.1161/CIRCULATIONAHA.107.696906. Epub 2007 Aug 27.

  PMID: 17724259 BACKGROUND

• Diaz-Toro F, Nazzal N C, Verdejo P H. [Incidence and hospital mortality due to heart failure. Are there any differences by sex?]. Rev Med Chil. 2017 Jun;145(6):703-709. doi: 10.4067/s0034-98872017000600703. No abstract available. Spanish.

  PMID: 29171617 BACKGROUND

• Lainscak M, Milinkovic I, Polovina M, Crespo-Leiro MG, Lund LH, Anker SD, Laroche C, Ferrari R, Coats AJS, McDonagh T, Filippatos G, Maggioni AP, Piepoli MF, Rosano GMC, Ruschitzka F, Simic D, Asanin M, Eicher JC, Yilmaz MB, Seferovic PM; European Society of Cardiology Heart Failure Long-Term Registry Investigators Group. Sex- and age-related differences in the management and outcomes of chronic heart failure: an analysis of patients from the ESC HFA EORP Heart Failure Long-Term Registry. Eur J Heart Fail. 2020 Jan;22(1):92-102. doi: 10.1002/ejhf.1645. Epub 2019 Dec 20.

  PMID: 31863522 BACKGROUND

• Castro P, Vukasovic JL, Garces E, Sepulveda L, Ferrada M, Alvarado S; Insuficiencia Cardiaca: Registro y Organizacion. [Cardiac failure in Chilean hospitals: results of the National Registry of Heart Failure, ICARO]. Rev Med Chil. 2004 Jun;132(6):655-62. doi: 10.4067/s0034-98872004000600001. Spanish.

  PMID: 15332366 BACKGROUND

• Vukasovic R JL, Castro G P, Sepulveda M L, Nazzal N C, Garces F E, Concepcion Ch R, Soto S JR, Yovaniniz L P, Ferrada K M, Cavada Ch G. [Characteristics of heart failure with preserved ejection fraction: results of the Chilean national registry of heart failure, ICARO]. Rev Med Chil. 2006 May;134(5):539-48. doi: 10.4067/s0034-98872006000500001. Epub 2006 Jun 19. Spanish.

  PMID: 16802045 BACKGROUND

• Kapoor JR, Kapoor R, Ju C, Heidenreich PA, Eapen ZJ, Hernandez AF, Butler J, Yancy CW, Fonarow GC. Precipitating Clinical Factors, Heart Failure Characterization, and Outcomes in Patients Hospitalized With Heart Failure With Reduced, Borderline, and Preserved Ejection Fraction. JACC Heart Fail. 2016 Jun;4(6):464-72. doi: 10.1016/j.jchf.2016.02.017.

  PMID: 27256749 BACKGROUND

• Jonsson A, Edner M, Alehagen U, Dahlstrom U. Heart failure registry: a valuable tool for improving the management of patients with heart failure. Eur J Heart Fail. 2010 Jan;12(1):25-31. doi: 10.1093/eurjhf/hfp175.

  PMID: 20023041 BACKGROUND

• Adamo M, Gardner RS, McDonagh TA, Metra M. The 'Ten Commandments' of the 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2022 Feb 10;43(6):440-441. doi: 10.1093/eurheartj/ehab853. No abstract available.

  PMID: 34922348 BACKGROUND

• Varleta P, Acevedo M, Casas-Cordero C, Berrios A, Navarrete C. Low Cardiovascular Disease Awareness in Chilean Women: Insights from the ESCI Project. Glob Heart. 2020 Aug 12;15(1):55. doi: 10.5334/gh.534.

  PMID: 32923348 BACKGROUND

• Acevedo M, Varleta P, Casas-Cordero C, Berrios A, Navarrete C, Lopez R. Prevalence and determinants of ideal cardiovascular health in a latin women cohort: a cross-sectional study. Lancet Reg Health Am. 2021 Sep 11;4:100071. doi: 10.1016/j.lana.2021.100071. eCollection 2021 Dec.

  PMID: 36776705 BACKGROUND

• Vogel B, Acevedo M, Appelman Y, Bairey Merz CN, Chieffo A, Figtree GA, Guerrero M, Kunadian V, Lam CSP, Maas AHEM, Mihailidou AS, Olszanecka A, Poole JE, Saldarriaga C, Saw J, Zuhlke L, Mehran R. The Lancet women and cardiovascular disease Commission: reducing the global burden by 2030. Lancet. 2021 Jun 19;397(10292):2385-2438. doi: 10.1016/S0140-6736(21)00684-X. Epub 2021 May 16.

  PMID: 34010613 BACKGROUND

• Lichtman JH, Bigger JT Jr, Blumenthal JA, Frasure-Smith N, Kaufmann PG, Lesperance F, Mark DB, Sheps DS, Taylor CB, Froelicher ES; American Heart Association Prevention Committee of the Council on Cardiovascular Nursing; American Heart Association Council on Clinical Cardiology; American Heart Association Council on Epidemiology and Prevention; American Heart Association Interdisciplinary Council on Quality of Care and Outcomes Research; American Psychiatric Association. Depression and coronary heart disease: recommendations for screening, referral, and treatment: a science advisory from the American Heart Association Prevention Committee of the Council on Cardiovascular Nursing, Council on Clinical Cardiology, Council on Epidemiology and Prevention, and Interdisciplinary Council on Quality of Care and Outcomes Research: endorsed by the American Psychiatric Association. Circulation. 2008 Oct 21;118(17):1768-75. doi: 10.1161/CIRCULATIONAHA.108.190769. Epub 2008 Sep 29.

  PMID: 18824640 BACKGROUND

• Bhatt KN, Kalogeropoulos AP, Dunbar SB, Butler J, Georgiopoulou VV. Depression in heart failure: Can PHQ-9 help? Int J Cardiol. 2016 Oct 15;221:246-50. doi: 10.1016/j.ijcard.2016.07.057. Epub 2016 Jul 5.

  PMID: 27404684 BACKGROUND

• Morley JE, Vellas B, van Kan GA, Anker SD, Bauer JM, Bernabei R, Cesari M, Chumlea WC, Doehner W, Evans J, Fried LP, Guralnik JM, Katz PR, Malmstrom TK, McCarter RJ, Gutierrez Robledo LM, Rockwood K, von Haehling S, Vandewoude MF, Walston J. Frailty consensus: a call to action. J Am Med Dir Assoc. 2013 Jun;14(6):392-7. doi: 10.1016/j.jamda.2013.03.022.

  PMID: 23764209 BACKGROUND

• Pina IL, Kokkinos P, Kao A, Bittner V, Saval M, Clare B, Goldberg L, Johnson M, Swank A, Ventura H, Moe G, Fitz-Gerald M, Ellis SJ, Vest M, Cooper L, Whellan D; HF-ACTION Investigators. Baseline differences in the HF-ACTION trial by sex. Am Heart J. 2009 Oct;158(4 Suppl):S16-23. doi: 10.1016/j.ahj.2009.07.012.

  PMID: 19782784 BACKGROUND

• Green CP, Porter CB, Bresnahan DR, Spertus JA. Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure. J Am Coll Cardiol. 2000 Apr;35(5):1245-55. doi: 10.1016/s0735-1097(00)00531-3.

  PMID: 10758967 BACKGROUND

• Reddy YNV, Carter RE, Obokata M, Redfield MM, Borlaug BA. A Simple, Evidence-Based Approach to Help Guide Diagnosis of Heart Failure With Preserved Ejection Fraction. Circulation. 2018 Aug 28;138(9):861-870. doi: 10.1161/CIRCULATIONAHA.118.034646.

  PMID: 29792299 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Coitus

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Sexual Behavior; Behavior

Study Officials

• PAOLA VARLETA, MD

  Fundacion de la Sociedad Chilena de Cardiologia y Cirugia Cardiovascular

  PRINCIPAL INVESTIGATOR

• MONICA ACEVEDO, MD

  Fundacion de la Sociedad Chilena de Cardiologia y Cirugia Cardiovascular

  PRINCIPAL INVESTIGATOR

Central Study Contacts

PAOLA VARLETA, MD

CONTACT

+569 95390767; pao.varleta@gmail.com

MONICA ACEVEDO, MD

CONTACT

+569 92282617; macevedo@ucchristus.cl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2023
• First Posted: July 27, 2023
• Study Start: August 11, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Only available upon request to the principal investigators after the acceptance of the first publication of the study. For two years
• Access Criteria: For international academic investigators belonging to: universities , university hospitals, public hospitals, cardiology societies , and cardiology foundations associated to cardiology colleges and associations.

Locations

CL (1)