Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Recruiting Observational

Heart Failure in Women: Epidemiological and Prognostic Insights

NCT07847983 · tracked via the Priya Life Science Spain tracker
Sponsor
Carolina Ortiz Cortes
Phase
Observational
Started
2026-09-17
Last updated
2026-09-29

Condition(s) studied

Heart Failure

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Composite of all-cause death or first rehospitalisation for heart failure — 12 months from enrolment
    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.

Trial sites (24)

FacilityCityRegionStatus
Hospital Clinico Universitario de Santiago de Compostela Santiago de Compostela A Coruna Recruiting
Hospital Universitario Donostia Donostia / San Sebastian Gipuzkoa Recruiting
Hospital San Juan de la Cruz Úbeda Jaen Recruiting
Hospital Universitario de Gran Canaria Doctor Negrin Las Palmas de Gran Canaria Las Palmas Recruiting
Hospital Universitario Fundacion Alcorcon Alcorcón Madrid Recruiting
Hospital Universitario HM Monteprincipe Boadilla del Monte Madrid Recruiting
Hospital Universitario Severo Ochoa Leganés Madrid Recruiting
Hospital Universitario Puerta de Hierro Majadahonda Majadahonda Madrid Recruiting
Hospital Universitario Central de Asturias Oviedo Principality of Asturias 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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07847983 on ClinicalTrials.gov ↗ ← All trials in Spain