NCT07847983From ClinicalTrials.govRecruiting

Heart Failure in Women: Epidemiological and Prognostic Insights

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

Heart Failure

At a glance

Phase: Phase not stated
Study type: Observational
Sponsor: Carolina Ortiz Cortes
Enrolment target: 430
Started: 17 September 2026
Main results due: 31 March 2028
Study sites: 24
Registry updated: 29 September 2026

Can you take part?

Aged 18 years and over.
Women only.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Inclusion Criteria:

* 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, or by her legal representative when decision-making capacity is preserved despite mild impairment, after verbal and written information.

Exclusion Criteria:

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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(24)

Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, A Coruna, Spain
Recruiting
Hospital Universitario Donostia
Donostia / San Sebastian, Gipuzkoa, Spain
Recruiting
Hospital San Juan de la Cruz
Úbeda, Jaen, Spain
Recruiting
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, Las Palmas, Spain
Recruiting
Hospital Universitario Fundacion Alcorcon
Alcorcón, Madrid, Spain
Recruiting
Hospital Universitario HM Monteprincipe
Boadilla del Monte, Madrid, Spain
Recruiting
Hospital Universitario Severo Ochoa
Leganés, Madrid, Spain
Recruiting
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain
Recruiting
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Recruiting
Complexo Hospitalario Universitario A Coruna
A Coruña, Spain
Recruiting
Hospital Universitario de Badajoz
Badajoz, Spain
Recruiting
Hospital Universitario de Burgos
Burgos, Spain
Recruiting
Hospital Universitario Puerta del Mar
Cadiz, Spain
Recruiting
Hospital Universitario de Caceres
Cáceres, Spain
Recruiting
Hospital Universitari de Girona Doctor Josep Trueta
Girona, Spain
Recruiting
Hospital Universitario Virgen de las Nieves
Granada, Spain
Recruiting
Complejo Asistencial Universitario de Leon
León, Spain
Recruiting
Hospital Central de la Defensa Gomez Ulla
Madrid, Spain
Recruiting
Hospital Universitario de La Princesa
Madrid, Spain
Recruiting
Hospital Universitario Infanta Leonor
Madrid, Spain
Recruiting
Hospital Universitario Ramon y Cajal
Madrid, Spain
Recruiting
Hospital Universitario de Toledo
Toledo, Spain
Recruiting
Hospital Universitario Doctor Peset
Valencia, Spain
Recruiting
Hospital Universitario Rio Hortega
Valladolid, Spain
Recruiting

Showing 24 of 24 sites. 24 of the 24 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07847983. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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