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RECRUITING
NCT07847983

Heart Failure in Women: Epidemiological and Prognostic Insights

Sponsor: Carolina Ortiz Cortes

View on ClinicalTrials.gov

Summary

Heart failure (HF) is a leading cause of hospital admission in older adults and women account for more than half of these admissions, yet they remain under-represented in prospective HF cohorts. Exposures specific to women, such as complications of pregnancy and the timing of menopause, are seldom recorded in HF registries, and treatment is usually described by drug class rather than by the dose actually achieved. HER-HF is a national, prospective, multicentre observational cohort study that enrols women aged 18 years or older admitted to hospital for a first episode of HF, irrespective of left ventricular ejection fraction, at Spanish hospitals with a dedicated heart failure unit. Recruitment is consecutive and all-comers. Participants are enrolled at discharge from the index admission or at the first heart failure unit visit within 15 days, and all baseline data refer to the index hospitalisation. Participants are followed for 12 months, with visits at 3, 6 and 12 months. The primary objective is descriptive: to characterise the epidemiological, clinical, diagnostic, therapeutic and prognostic profile of women with de novo HF. Secondary objectives are to evaluate the association between sex-specific reproductive exposures and 12-month prognosis; to describe the doses of disease-modifying therapy achieved and the reasons for non-titration; to compare the cohort with a contemporary cohort of men with newly diagnosed HF; and to analyse differences by ejection fraction phenotype and by age.

Official title: HER-HF: Heart Failure in Women. Epidemiological and Prognostic Insights. A National, Prospective, Multicentre Observational Cohort Study of Women Hospitalised for a First Episode of Heart Failure

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

430

Start Date

2026-09-17

Completion Date

2028-06-30

Last Updated

2026-09-29

Healthy Volunteers

No

Conditions

Locations (24)

Hospital Clinico Universitario de Santiago de Compostela

Santiago de Compostela, A Coruna, Spain

Hospital Universitario Donostia

Donostia / San Sebastian, Gipuzkoa, Spain

Hospital San Juan de la Cruz

Úbeda, Jaen, Spain

Hospital Universitario de Gran Canaria Doctor Negrin

Las Palmas de Gran Canaria, Las Palmas, Spain

Hospital Universitario Fundacion Alcorcon

Alcorcón, Madrid, Spain

Hospital Universitario HM Monteprincipe

Boadilla del Monte, Madrid, Spain

Hospital Universitario Severo Ochoa

Leganés, Madrid, Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, Spain

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Complexo Hospitalario Universitario A Coruna

A Coruña, Spain

Hospital Universitario de Badajoz

Badajoz, Spain

Hospital Universitario de Burgos

Burgos, Spain

Hospital Universitario Puerta del Mar

Cadiz, Spain

Hospital Universitario de Caceres

Cáceres, Spain

Hospital Universitari de Girona Doctor Josep Trueta

Girona, Spain

Hospital Universitario Virgen de las Nieves

Granada, Spain

Complejo Asistencial Universitario de Leon

León, Spain

Hospital Central de la Defensa Gomez Ulla

Madrid, Spain

Hospital Universitario de La Princesa

Madrid, Spain

Hospital Universitario Infanta Leonor

Madrid, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Hospital Universitario de Toledo

Toledo, Spain

Hospital Universitario Doctor Peset

Valencia, Spain

Hospital Universitario Rio Hortega

Valladolid, Spain