Oral dIuretics in Very Intensive Treatment, an Early Intervention in Outpatients With Heart Failure. DIVINE STUDY
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- MORTALITY
研究概览
简要总结
In the present study, consecutive patients, older than 18 years, of both genders will be included. The diagnosis of reduced Heart Failure (HfrEF) according to: Clinical pattern, laboratories and Cardiac imaging (ESC criteria). Treatment will be assigned in two groups: Bumetanide and another group will be received Indapamide. Each group received maximum tolerated dose for seven days with Clinical and labs evaluations will be every 48 hrs. (Face-to-face and/or telephone visits). Serum and urinary labs, EKG´s, Echo will be evaluated. Daily in-home register will made. Final points were: Mortality, Urinary failure, Clinical Impairment, Hospital admissions, Oedema. (MUCHO). All patients will be followed for 30 days.
详细描述
In selected patients who sign informed consent with decompensation of cardiac failure by water congestion will be allocated in two groups: Bumetanide and the other Indapamide group. Each group will be given the maximum tolerated dose for seven days with clinical evaluations every 48 hours. (Face to face and/or telephone). Clinical variables, ECG and serum and urine laboratories will be assessed finally, patients will follow up for 30 days. To identify endpoints such as: mortality, urinary failure, clinical deterioration, hospital admissions, edema. (MUCHO).
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older over 18 year
- •Both gender.
- •Patients are able to read, write and understand. 4.-Heart failure criteria:a) Clinical signs and symptoms b) serum NTP-proBNP: over 125pg/ml. or serum bnp: over: 35pg/ml. c) Left ventricular ejection fraction under 40% ( By any image study: echocardiogram, Tomography , MRI,Nuclear medicine.)
- •Commitment to participate in the follow-up of the present study.
排除标准
- •Pregnant or lactating women.
- •Patients with deterioration of their clinical condition that warrant rapid attention by the emergency department.
- •Patients with symptomatic hypotension by arterial pressure over; 90/50 mmHg.
- •Symptomatic heart rate disorders: tachycardia greater than 120 beats per minute or bradycardia less than 50 beats per minute.
- •Patients with respiratory impairment: by tachypnea (respiratory rate greater than 22 per min), peripheral oxygen saturation less than 90%.
- •Clinical signs or by methods of pleural effusion image that compromise the ventilatory mechanism.
- •Hormonal thyroid decontrol (thyroid hormone profile outside the reference range)
- •Serum glucose numbers greater than 140mg/DL and/or glycosylated hemoglobin greater than 6.5%.
- •Renal damage characterized by serum creatinine numbers greater than 1.5 mg/DL.
- •Alteration of the hepatic test: serum aspartate aminotransferase and/or serum alanine aminotransferase by levels greater than three times the upper limit of reference.
- •Alterations in serum electrolytes (by sodium greater 135 mmol/L or less 145 mmol; Potassium less than 3.5 mmol/L or higher 5.35 mmol/L)
- •Intolerance or allergy recognized for any diuretic.
- •Comorbidities that prevent the follow-up of treatment: (Alcoholism, drug addiction, psychiatric disorders)
- •Positive serology carriers for Hepatitis (B, C) HIV.
- •Acute myocardial infarction (with and without elevation) in the last three months.
- •History of vascular (ischemic or hemorrhagic) brain disease in the last three months.
- •Carriers of acute inflammatory and/or immunologic disease in the last three months (e.g. Active Lupus etc.)
- •Active myocarditis in the last three months
- •History of Prostatism, or recognized prostatic alterations, that impede voiding flow.
- •Terminal cancer
- •Blunt physical and cognitive deterioration that prevents optimal follow-up.
- •Cultural barriers involving limitation of communication (languages, dialects, reading and writing, etc.).
- •Not to sign informed consent
研究组 & 干预措施
BUMETANIDE
we will administrated bumetanide at dosis: oral, 2mg each 8hours for seven day.
干预措施: Bumetanide 1 MG (Drug)
INDAPAMIDE
we will administrated indapamide at dosis:oral,1.5MG each 8hours for seven day.
干预措施: Bumetanide 1 MG (Drug)
结局指标
主要结局
MORTALITY
时间窗: 30 DAY
HEART FAILURE DEATH, CARDIOVASCULAR DEATH, OTHER DEATH
次要结局
- REHOSPITALIZATION(30 DAY)
- URINARY FAILURE(30 DAY)
- CLINICAL IMPAIRMENT(30 DAY)
- OEDEMA(30 DAY)
研究者
EDUARDO CHUQUIURE-VALENZUELA MD MSc FACC
Principal Investigator
Centro en Insuficiencia Cardiaca, Mexico