2025-520660-18-00招募中4 期
Pharmacological optimization in prevention in Heart Failure: A Sex-gap? (PopS-HF Trial)
Policlinico San Donato S.p.A.13 个研究点 分布在 1 个国家目标入组 368 人开始时间: 2025年11月17日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 368
- 试验地点
- 13
- 主要终点
- Retrospective study: an up-to-date description of the “status quo” of the prescription of GDMT nationally and related inequality regarding sex in patients with HF based on analyses of National Registry data and Mecki Data-base. Prospective study: • all-cause mortality within 1 year or HF readmission or worsening HF.
研究概览
简要总结
Retrospective study To better understand the implementation of the life-saving GDMT therapies and to fill in the sex-gaps.
Prospective study To evaluate in a prospective pragmatic multi-centre trial, whether HF women at 12 months -follow-up, randomisation to up-titration of GDMT (following STRONG-HF titration programme) vs usual care may affect a. Morbidity and mortality b. Quality of life c. Adherence to drug, as defined as suspension or dose reduction d. Side-effects
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Retrospective study All individuals with HF regardless of the left ventricular ejection fraction Prospective study
- •Female patients >18 <85 years
- •Hospital admission within the 24-48 hours prior to Screening for acute heart failure with dyspnea at rest and pulmonary congestion on chest X-ray, and other signs and/or symptoms of heart failure such as edema and/or positive rales on auscultation.
- •All measures within 24 hours prior to Randomization of systolic blood pressure ≥ 100 mmHg, and of heart rate ≥ 60 bpm.
- •All measures within 24 hours prior to Randomization of serum potassium ≤ 5.0 mEq/L (mmol/L).
- •Biomarker criteria for persistent congestion: 5.
- •At Screening, NT-proBNP >1,800 pg/mL (2,350 pg/mL in case of atrial fibrillation) 5.
- •At the time of Randomization (1-2 days prior to discharge), NT-proBNP >1,000 pg/mL (1,300 pg/mL in case of Atrial Fibrillation) to ensure the persistence of congestion and the acuity of the index episode).
- •At 1 week prior to admission, at Screening, and at Visit 2 6.
- •If EF<50% (ie HFrEF or HFmrEF) either <½ the optimal dose of ACEi/ARB/ARNi and MRA and BB (see Table) must have been prescribed 6.
- •If EF>50% (ie HFpEF): <½ the optimal dose of MRA (see Table)
- •Written informed consent to participate in the study.
排除标准
- •Male patients
- •Age < 18 or > 85 years.
- •Mechanical ventilation (not including CPAP/BIPAP) in the 24 hours prior to Screening.
- •Significant pulmonary disease contributing substantially to the patients’ dyspnoea such as FEV1 <1 liter or need for chronic systemic or nonsystemic steroid therapy, or any kind of primary right heart failure such as primary pulmonary hypertension or recurrent pulmonary embolism.
- •Myocardial infarction, unstable angina or cardiac surgery within 3 months, or cardiac resynchronization therapy (CRT) device implantation within 3 months, or percutaneous transluminal coronary intervention (PTCI), within 1 month prior to Screening or during the index event.
- •Index Event (admission for AHF) triggered primarily by a correctable aetiology such as significant arrhythmia (e.g., sustained ventricular tachycardia, or atrial fibrillation/flutter with sustained ventricular response >130 beats per minute, or bradycardia with sustained ventricular arrhythmia <45 beats per minute), infection, severe anaemia, acute coronary syndrome, pulmonary embolism, exacerbation of COPD, planned admission for device implantation or severe non-adherence leading to very significant fluid accumulation prior to admission and brisk diuresis after admission. Troponin elevations without other evidence of an acute coronary syndrome are not an exclusion.
- •Uncorrected thyroid disease, active myocarditis, or known amyloid or hypertrophic obstructive cardiomyopathy.
- •History of heart transplant or on a transplant list or using or planned to be implanted with a ventricular assist device.
- •Sustained ventricular arrhythmia with syncopal episodes within the 3 months prior to screening that is untreated.
- •Presence at Screening of any hemodynamically significant valvular stenosis or regurgitation, except mitral or tricuspid regurgitation secondary to left ventricular dilatation, or the presence of any hemodynamically significant obstructive lesion of the left ventricular outflow tract.
- •Active infection at any time during the AHF hospitalization prior to Randomization based on abnormal temperature and elevated WBC or need for intravenous antibiotics.
- •Stroke or TIA within the 3 months prior to Screening.
- •Primary liver disease considered to be life threatening.
- •Renal disease or eGFR < 30 mL/min/1.73m2 (as estimated by the simplified MDRD formula) at Screening or history of dialysis.
- •Psychiatric or neurological disorder, cirrhosis, or active malignancy leading to a life expectancy < 6 months.
- •Prior (defined as less than 30 days from screening) or current enrollment in a CHF trial or participation in an investigational drug or device study within the 30 days prior to screening
- •Discharge for the AHF hospitalization anticipated to be >14 days from admission, or to a long-term care facility. Randomization must occur within 12 days following admission and at 1-2 days prior to anticipated discharge.
- •Inability to comply with all study requirements, due to major co-morbidities, social or financial issues or a history of noncompliance with medical regimens, that might compromise the patient’s ability to understand and/or comply with the protocol instructions or follow-up procedures
- •Pregnant or nursing (lactating) women.
结局指标
主要结局
Retrospective study: an up-to-date description of the “status quo” of the prescription of GDMT nationally and related inequality regarding sex in patients with HF based on analyses of National Registry data and Mecki Data-base. Prospective study: • all-cause mortality within 1 year or HF readmission or worsening HF.
Retrospective study: an up-to-date description of the “status quo” of the prescription of GDMT nationally and related inequality regarding sex in patients with HF based on analyses of National Registry data and Mecki Data-base. Prospective study: • all-cause mortality within 1 year or HF readmission or worsening HF.
次要结局
- Prospective study: a.the percentage of optimization of each single medical therapy (BB; ACEi, ARB or ARNi;and MRAs and SGLT2i)in women admitted with heart failure, b.effect of such intervention at 1 year:mortality;HF re-admission;worsening HF;quality of life (EQ-5D questionnaire). c.Other endpoints:include changes in biomarkers and changes in the primary and secondary endpoints in pre-determined subgroups including <50vs>50 EF;>vs<65 yr old,presence of diabetes,chronic kidney disease or obesity
研究者
PI
Scientific
Policlinico San Donato S.p.A.
研究点 (13)
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