Effectiveness of an Interdisciplinary Intervention on Frailty Geriatric Patients With Heart Failure.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Mortality
研究概览
简要总结
There is enough scientific evidence of the benefits detection of frailty in patients with heart failure, which is an important prognostic factor. The usefulness of screening frailty as flattering tool making diagnostic and therapeutic decisions in patients with heart failure and now emerges in various recent studies. However, it is not found in the literature any study on the potential effectiveness of a comprehensive intervention on the fragility that includes the physical section (endurance, strength, flexibility and balance), nutritional, hormonal (supplementation deficit D vitamin) and pharmacological (adjusted to clinical guidelines according to requirements) in patients with heart failure after hospitalization for cardiac decompensation, to improve survival and reduce cardiac decompensation and hospital admissions resulting in a better quality of life for these patients. Therefore, the investigators designed the following study.
详细描述
HYPOTHESIS Comprehensive intervention fragility in patients older than 70 years after hospitalization for cardiac decompensation improves survival and quality of life of these patients and reduces decompensation and hospital admissions.
OBJECTIVES
Main objective:
- Check if a comprehensive program of frail elderly patients diagnosed with heart failure improves survival in patients with heart failure.
Secondary objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 70 years.
- •Individuals hospitalized in internal medicine at the Hospital de la Ribera with primary or secondary diagnosis of heart failure as before:
- •I. Clinical heart failure criteria. (Clinical Practice Guidelines 2012 HF) (Annex 1).
- •II. Evidence of ventricular systolic or diastolic dysfunction on echocardiographic (TTE).
- •Pre-frailty or frailty according to the Fried frailty scale, fulfilling at least 1 criterion.
- •Signature reported for inclusion in the study consent.
排除标准
- •Expectation of life less than one year.
- •Cancer Patient in active treatment with chemotherapy / biotherapy or radiotherapy.
- •Major surgery within 6 months prior to baseline.
- •Barthel score ≤ 50 points.
- •Moderate to severe cognitive impairment measured by GDS ≥ 5
- •Severe valvular measured by echocardiogram in the last 6 months.
- •Percutaneous or surgical coronary revascularization in the last 3 months.
- •Acute coronary event in the last month.
- •Dyspnoea baseline NYHA IV / IV.
- •COPD / Asthma severe degree or other pathology that conditions severe impairment of lung function.
结局指标
主要结局
Mortality
时间窗: 365 days (plus or minus 3 days)
The primary study endpoint is the mortality reduction.
次要结局
- Mini-Mental State Examination (MMSE)(365 days(plus or minus 3 days))
- Short Physical Performance Battery and Physical Performance Test(365 days(plus or minus 3 days))
- Composite effect of a multicomponent training intervention on systemic biomarkers of frailty(365 days(plus or minus 3 days))
- Quality of life: EuroQol-5D(365 days(plus or minus 3 days))
- Geriatric Depression Scale(365 days(plus or minus 3 days))
研究者
Josep Esteve Portalés.
Medicine doctor.
Hospital de la Ribera