Life sciences · Observational Study
ClinicalTrials.gov · September 29, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT07847983). This is a study registration, not published results. Lead sponsor: Carolina Ortiz Cortes. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 430 participants (ESTIMATED). Conditions: Heart Failure. Primary outcome measures: Composite of all-cause death or first rehospitalisation for heart failure , 12 months from enrolment. Brief 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.