Effect of Moderate vs Severe Sodium Restriction on Brain Natriuretic Peptide in Patients With Heart Failure and Reduced Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Brain natriuretic peptide
研究概览
简要总结
The SODA-HF trial is a randomized, double-blind, controlled trial to evaluate the effect of moderate to severe sodium restriction on brain natriuretic peptide in patients with heart failure and reduced ejection fraction (less than 40%).
Secondary outcomes are quality of life, NYHA functional class, glomerular filtration rate, renin plasmatic activity, aldosterone and composite clinical outcome (all-cause mortality and cardiovascular hospitalization)
详细描述
Allocation: Those patients who meet the selection criteria will go to the nutritionist who will make the assignment to one of the sodium restriction groups.
Generation of the sequence: patients will be assigned to the two groups based on a table of random numbers generated by a statistical analysis program. Blocks of 10 will be used.
Mechanism of concealment of the assignment: the nutritionist will be the only person who will know to which group the patient was assigned, the patient will not know to which group was assigned, neither will the researcher know. The person in charge of measuring the results will also be blinded.
Description of the intervention: the nutritionist will be the one to calculate diets appropriate to the needs of each of the patients. Patients will be allowed a maximum intake of 1.5 liters of water per day, including the liquid of soups, juices and drinks; This will be explained in detail to the patients. The diets will be identical in calories according to the weight of the patient. The only difference in diets will be the sodium content, which will be 3 grams of sodium vs. 2 grams of sodium.
Blinding: The patients, the researcher and those responsible for measuring the results will be blinded to the assignment of the intervention. Patients will not know which group they have been assigned to since they will not know the sodium content of the diet nor will they be aware of what diet the other patients were assigned to. Those responsible for conducting laboratory studies will not know to which group the patients have been assigned.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of stable heart failure and decreased left ventricular ejection fraction. Such definition will contemplate the following:
- •Patients should have an echocardiogram of maximum 6 months old with a left ventricular ejection fraction of less than 40%.
- •Functional class I, II or III of the NYHA
- •Optimal medical treatment which should include: an angiotensin converting enzyme inhibitor or angiotensin receptor blocker ARA, and a beta-blocker; or inability to tolerate these medications.
- •No changes in pharmacological treatment in the last 4 weeks.
- •Systolic blood pressure greater than or equal to 90 mmHg.
- •Informed consent to participate in the study.
排除标准
- •A hospitalization for heart failure less than one month ago. Chronic kidney disease: glomerular filtration rate estimated by the formula of CKD-EPI <30 ml / min / 1.73 m
- •Hyponatremia: Sodium less than 130 mmol / l. Anemia: Hemoglobin less than 10 g / dl. Patients who will be taken to any type of intervention in the next 12 months in order to improve ventricular function, such as percutaneous coronary intervention or surgical revascularization Any valvulopathy of severe degree. Dementia Cancer Patients who have planned change of address in the next 12 months.
结局指标
主要结局
Brain natriuretic peptide
时间窗: 20 weeks
Brain natriuretic peptide (NT-proBNP) will be compared at the end of the intervention.
次要结局
- Aldosterone(20 weeks)
- Composite clinical outcome(20 weeks)
- NYHA functional class(20 weeks)
- Improvement in Quality of life(20 weeks)
- Renin plasmatic activity(20 weeks)
- Measured glomerular filtration rate(20 weeks)
研究者
Eduardo Almeida Gutiérrez
Dr
Instituto Mexicano del Seguro Social