Heart Failure in Women: Epidemiology and Prognosis Insights
Official title: 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
Run by Universidad de Extremadura · NCT07847983 · Data updated 2026-11-12
This study tests how factors unique to women, including pregnancy history and menopause timing, relate to first-time heart failure and its outcomes over a year in Spain.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 430 (estimated) |
| Sponsor | Universidad de Extremadura Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 24 sites (A Coruña, A Coruna and 23 other locations) |
| Status | Recruiting |
| Started | September 17, 2026 |
| Main results expected | March 31, 2028 |
| Study ends | June 30, 2028 |
| Registry record updated | October 21, 2026 |
| Trial ID | NCT07847983 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18 or older hospitalized for a first episode of heart failure, regardless of ejection fraction, at participating Spanish centers.
✕Probably not a fit
Patients with severe frailty, significant cognitive impairment, terminal illness, or inability to complete follow-up may derive limited benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
HER-HF is a national, prospective, multicenter observational cohort enrolling women 18 and older admitted for a first episode of heart failure at 24 Spanish hospitals. Data are collected from the index hospitalization and follow-up visits occur at 3, 6, and 12 months, with a centralized encrypted database capturing clinical, sex-specific risk factors, treatments, and patient-reported outcomes. The study records detailed pregnancy-related history, menopause details, social determinants, and treatment Dose bands to understand prognostic factors beyond traditional metrics. All participants provide informed consent, and exclusion criteria include severe frailty, cognitive impairment, terminal illness, or inability to complete follow-up. Analyses focus on associations between sex-specific variables and HF outcomes to improve understanding and care for women with HF.
Why it matters
Potential benefit: Findings could improve risk stratification and personalized management of heart failure in women by incorporating pregnancy history and menopause-related factors.
How similar studies have gone: Previous cohorts have highlighted sex-specific risk factors in HF, but this study's comprehensive pregnancy and menopause data in a real-world setting is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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 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 judgment. * Inability to complete clinical follow-up or subsequent contact (for example, no contact details available, or transfer to a center outside the network). * Any previous diagnosis of heart failure.
Where it's running
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Complexo Hospitalario Universitario A Coruna
A Coruña, A Coruna, Spain Recruiting -
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, A Coruna, Spain Recruiting -
Hospital Universitario de Badajoz
Badajoz, Badajoz, Spain Recruiting -
Hospital Universitario de Burgos
Burgos, Burgos, Spain Recruiting -
Hospital Universitario de Caceres
Cáceres, Caceres, Spain Recruiting -
Hospital Universitario Puerta del Mar
Cadiz, Cadiz, Spain Recruiting
Show 18 more locations
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Hospital Universitario Donostia
Donostia / San Sebastian, Gipuzkoa, Spain Recruiting -
Hospital Universitari de Girona Doctor Josep Trueta
Girona, Girona, Spain Recruiting -
Hospital Universitario Virgen de las Nieves
Granada, Granada, 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 -
Complejo Asistencial Universitario de Leon
León, Leon, 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 Central de la Defensa Gomez Ulla
Madrid, Madrid, Spain Recruiting -
Hospital Universitario de La Princesa
Madrid, Madrid, Spain Recruiting -
Hospital Universitario Infanta Leonor
Madrid, Madrid, Spain Recruiting -
Hospital Universitario Ramon y Cajal
Madrid, Madrid, Spain Recruiting -
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain Recruiting -
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain Recruiting -
Hospital Universitario de Toledo
Toledo, Toledo, Spain Recruiting -
Hospital Universitario Doctor Peset
Valencia, Valencia, Spain Recruiting -
Hospital Universitario Rio Hortega
Valladolid, Valladolid, Spain Recruiting
Study contacts
- Principal investigator: Carolina Ortiz Cortes, MD — Hospital Universitario Fundacion Alcorcon
- Study coordinator: Carolina Ortiz Cortes, MD
- Email: carol.ortizcortes@secardiologia.es
- Phone: +34 91 621 94 00
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.