Following women through their first hospital stay for heart failure

Trial details

Who runs it

Carolina Ortiz Cortes

Trial code

NCT07847983

Record updated

21 October 2026

Original description

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. Risk factors 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.Read full original descriptionShow less

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

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. Risk factors 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, multicenter observational cohort study that enrolls women aged 18 years or older admitted to hospital for a first episode of HF, irrespective of left ventricular ejection fraction, at 24 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 hospitalization. Participants are followed for 12 months, with visits at 3, 6 and 12 months.

The primary objective is descriptive: to characterize the epidemiological, clinical, diagnostic, therapeutic and prognostic profile of women with de novo HF, from the index admission through 12 months. Secondary objectives are: (1) to evaluate the association of sex-specific risk factors with the clinical profile, the type of HF (ejection fraction phenotype and etiology), the management received and 12-month prognosis, adjusted for traditional risk factors; (2) to examine the association of individual social determinants (household income, number of people in the household and educational attainment) with the type of HF, age at onset, management and outcome; and (3) to compare the cohort with a contemporary cohort of men with newly diagnosed HF (TIDY-HF registry) to identify sex-specific differences. The principal prognostic endpoint is the composite of all-cause death or HF decompensation (hospitalization for HF, or an unplanned emergency department or day-hospital visit for HF) within 12 months.

Inclusion: Women aged 18 years or older; Hospital admission with a first episode of heart failure confirmed by the treating team according to current clinical practice guidelines, irrespective of left ventricular ejection fraction; Written informed consent given by the participant after verbal and written information.

Exclusion: Any previous diagnosis of heart failure; Moderate-to-severe cognitive impairment, defined as 5 or more errors on the Pfeiffer questionnaire, adjusted for educational attainment; Terminal illness unrelated to heart failure with an expected survival of less than 6 months according to clinical judgment; Total functional dependence, defined as a Barthel index score of 20 or less (0-100 version); Severe frailty, defined as a Clinical Frailty Scale score of 6 or more; Inability to complete clinical follow-up or subsequent contact (for example, no contact details available, or transfer to a center outside the network).

ClinicalTrials.gov NCT07847983