Heart Failure in Women: Epidemiological and Prognostic Insights
HER-HF
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
1 other identifier
observational
430
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2026
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 17, 2026
CompletedFirst Submitted
Initial submission to the registry
September 22, 2026
CompletedFirst Posted
Study publicly available on registry
September 29, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
September 29, 2026
September 1, 2026
1.5 years
September 22, 2026
September 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite of all-cause death or first rehospitalisation for heart failure
Time to the first occurrence of either death from any cause or a first hospital admission with heart failure as the principal reason for admission, adjudicated from clinical records at each scheduled visit.
12 months from enrolment
Secondary Outcomes (11)
All-cause mortality
12 months from enrolment
Rehospitalisation for heart failure
12 months from enrolment
Prevalence of sex-specific reproductive exposures
Baseline (index hospitalisation)
Distribution of left ventricular ejection fraction phenotype
Baseline (index hospitalisation)
Use and achieved dose of disease-modifying heart failure therapy
Discharge from the index hospitalisation and 3, 6 and 12 months
- +6 more secondary outcomes
Study Arms (1)
Women with a first hospitalisation for heart failure
Women aged 18 years or older admitted to hospital with a first episode of heart failure confirmed by the treating team according to current clinical practice guidelines, irrespective of left ventricular ejection fraction, and with no previous diagnosis of heart failure. Participants are enrolled consecutively (all-comers) at discharge from the index admission or at the first heart failure unit visit within 15 days of discharge, and are followed for 12 months with visits at 3, 6 and 12 months. No intervention is assigned by the protocol; all diagnostic and therapeutic decisions are made by the treating clinician as part of routine care.
Eligibility Criteria
Women aged 18 years or older admitted to hospital with a first episode of heart failure at participating Spanish centres, all of which have a dedicated heart failure unit. Recruitment is consecutive and all-comers: every woman meeting the criteria during the recruitment period is offered participation, and discretionary selection by investigators is not permitted. Each centre declares a fixed screening frame in advance and keeps a screening log of women screened, women confirmed eligible, women enrolled, and eligible women not enrolled with the reason.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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, 28922, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carolina Ortiz Cortes, MD
Hospital Universitario Fundacion Alcorcon
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- National Coordinating Investigator, Department of Cardiology, Hospital Universitario Fundacion Alcorcon
Study Record Dates
First Submitted
September 22, 2026
First Posted
September 29, 2026
Study Start
September 17, 2026
Primary Completion (Estimated)
March 31, 2028
Study Completion (Estimated)
June 30, 2028
Last Updated
September 29, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be made publicly available. Requests for scientific collaboration should be addressed to the coordinating investigator and will be considered by the steering committee of the registry.