Clinical trial Recruiting at 24 sites Observational Ages 18 and up Women only

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.

More Heart Failure trials

Quick facts

Study typeObservational
Ages18 Years and up
SexWomen only
Enrollment430 (estimated)
SponsorUniversidad de Extremadura
Academic / other
Drugs / interventionschemotherapy
Locations24 sites (A Coruña, A Coruna and 23 other locations)
StatusRecruiting
StartedSeptember 17, 2026
Main results expectedMarch 31, 2028
Study endsJune 30, 2028
Registry record updatedOctober 21, 2026
Trial IDNCT07847983 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

  • 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
  • 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.