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NCT07847983Recruiting

Heart Failure in Women: Epidemiological and Prognostic Insights

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

Source: ClinicalTrials.gov · Last updated 21 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
430 (estimated)
First submitted
22 Sept 2026
Start date
17 Sept 2026
Primary completion date
31 Mar 2028
Lead sponsor
Carolina Ortiz Cortes
NCT number
NCT07847983

What you commit to

  • Study type: Observational
  • Planned participants: 430
  • From 17 Sept 2026 to the primary completion date, 31 Mar 2028
  • 24 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Any previous diagnosis of heart failure.

Other illness

  • 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.

Other

  • 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).

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (24)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainRecruiting
Hospital Universitario Fundación Alcorcón
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AlcorcónSpainRecruiting
Hospital Universitario de Badajoz
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BadajozSpainRecruiting
Hospital Universitario HM Monteprincipe
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Boadilla del MonteSpainRecruiting
Hospital Universitario De Burgos
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BurgosSpainRecruiting
Hospital Universitario De Caceres
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CaceresSpainRecruiting
Hospital Universitario Puerta del Mar
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CadizSpainRecruiting
Hospital Universitario Donostia
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Donostia / San SebastianSpainRecruiting
Hospital Universitari de Girona Doctor Josep Trueta
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GironaSpainRecruiting
Hospital Universitario Virgen de las Nieves
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GranadaSpainRecruiting
Hospital Universitario de Gran Canaria Doctor Negrín
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Las Palmas de Gran CanariaSpainRecruiting
Hospital Universitario Severo Ochoa
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LeganésSpainRecruiting
Complejo Asistencial Universitario de Leon
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LeónSpainRecruiting
Hospital Universitario Infanta Leonor
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MadridSpainRecruiting
Hospital Universitario Ramón y Cajal
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MadridSpainRecruiting
Hospital Central de la Defensa Gómez Ulla
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MadridSpainRecruiting
Hospital Universitario de la Princesa
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MadridSpainRecruiting
Hospital Universitario Puerta de Hierro - Majadahonda
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MajadahondaSpainRecruiting
Hospital Universitario Central De Asturias
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OviedoSpainRecruiting
Hospital Clínico Universitario de Santiago de Compostela
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Santiago de CompostelaSpainRecruiting
Hospital Universitario de Toledo
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ToledoSpainRecruiting
Hospital San Juan de la Cruz
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ÚbedaSpainRecruiting
Hospital Universitario Doctor Peset
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ValenciaSpainRecruiting
Hospital Universitario Rio Hortega
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ValladolidSpainRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.