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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 430
- 试验地点
- 24
- 主要终点
- Composite of all-cause death or first rehospitalisation for heart failure
研究概览
简要总结
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.
详细描述
Data are collected in a centralised, encrypted electronic case report form. Baseline variables include demographics, cardiovascular risk factors and comorbidity, previous cardiological history and prior medication; sex-specific reproductive exposures (number of pregnancies and deliveries, pre-eclampsia, eclampsia or HELLP syndrome, gestational hypertension and gestational diabetes, preterm delivery, intrauterine growth restriction or small-for-gestational-age newborn, peripartum cardiomyopathy, recurrent pregnancy loss, menopausal status and age at menopause, hormone replacement therapy, polycystic ovary syndrome and endometriosis); clinical features of the index episode; laboratory, electrocardiographic and echocardiographic data; cardiac magnetic resonance, coronary angiography and other investigations when performed; treatment at discharge by drug class and dose band; and the Barthel index, the Pfeiffer questionnaire, the five-item Geriatric Depression Scale and the 12-item Kansas City Cardiomyopathy Questionnaire.
At each follow-up visit the following are recorded: functional class, physical examination for residual congestion, weight and blood pressure, laboratory tests and electrocardiogram, echocardiography when clinically indicated, current treatment with doses, tolerability and adverse effects, emergency department attendances and day-hospital treatments, hospitalisations for heart failure, for other cardiovascular causes and for non-cardiovascular causes, referral to cardiac rehabilitation and referral for advanced therapies. Vital status and cause of death are recorded throughout. Functional scales are repeated at 12 months.
To document and control selection bias, each site declares a fixed screening frame in advance and maintains a screening log recording the number of women screened, the number confirmed eligible, the number enrolled, and the number of eligible women not enrolled with the reason. Participation rates will be reported by site.
The planned sample size is approximately 430 women, to yield at least 385 evaluable participants, which allows proportions to be estimated with an absolute precision of 5 per cent and 95 per cent confidence.
研究设计
- 研究类型
- 观察性
- 观察模型
- 队列研究
- 时间视角
- 前瞻性
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 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.
排除标准
- 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.
研究组 & 干预措施
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.
结局指标
主要结局
Composite of all-cause death or first rehospitalisation for heart failure
时间窗: 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.
次要结局
- 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)
- Adverse effects limiting disease-modifying therapy(12 months from enrolment)
- Change in the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) overall summary score(Baseline and 12 months)
- Functional and cognitive status scales(Baseline and 12 months)
- Emergency department attendances and day-hospital treatments for heart failure(12 months from enrolment)
- Referral to cardiac rehabilitation and to advanced heart failure therapies(12 months from enrolment)
- Hospitalisation for cardiovascular causes other than heart failure and for non-cardiovascular causes(12 months from enrolment)
研究者
Carolina Ortiz Cortes
National Coordinating Investigator, Department of Cardiology, Hospital Universitario Fundacion Alcorcon
Universidad de Extremadura
研究点 (24)
标识符
- NCT 编号
- NCT07847983
- 其他研究编号
- HER-HF-2026
日期
- 首次提交
- (8天前)
- 首次发布
- (昨天)
- 主要完成日期
- (明年)
- 研究完成日期
- (明年)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
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.