Aliskiren and Renin Inhibition in Diastolic Heart Failure in Mexican Americans
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Evaluate the superiority of aliskiren plus spironolactone combination over an lisinopril plus spironolactone combination in inhibiting the RAAS system among patients with diastolic HF.
研究概览
简要总结
This study is being conducted to compare the effects that 2 different combinations of heart failure medications have on the levels of certain blood markers which cause and/or worsen heart failure. Additionally, the investigators will investigate any differences that may exist between Hispanics and Non-Hispanics. The investigators hope to find that Hispanic Americans will have a greater response to this new regimen compared to non-Hispanic Americans.
详细描述
Our main hypothesis is that in contrast to non Hispanic whites, the degree of RAAS system activation is more pronounced in Mexican Americans with diastolic HF and consequently their response to RAAS inhibition therapy is greater. Blocking the RAAS with renin inhibitor plus aldosterone receptor blocker should produce measurable changes in biomarkers as well as physiologic improvement that could therefore translate into improved clinical outcomes. These changes should be greater appreciated in Mexican Americans if the central pathophysiologic influence of HF in this population was RAAS maladaptation.
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
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic stable diastolic HF documented by clinical diagnosis and echocardiogram within the last 2 years
- •NYHA classes I-III, symptomatically stable (for >1month)
- •Age 21-70 years
- •Either of Hispanic ethnicity (Mexican American origin) or non-Hispanic white
- •Patients on ACE inhibitor therapy (lisinopril)
- •Blood pressure >100/75 mmHg
- •Adequate birth control
- •Patients seen in TTUHSC Cardiology or Internal Medicine clinic for at least two visits since January 2008
排除标准
- •Acute coronary syndrome (within the last month).
- •Recent acute diastolic or systolic HF (within the last month)
- •Pancreatic disease
- •Renal artery stenosis
- •History of angioedema
- •Severe hypotension (systolic BP<90mmHg or mean arterial pressure <65mmHg)
- •Hyperkalemia (defined by K+>5 mEq/L)
- •Chronic Kidney Disease (Stage 3 and above)
- •Systolic dysfunction (ejection fraction below 50%)
- •Ethnicity other than Mexican American or non-Hispanic white
研究组 & 干预措施
Drug
Aliskiren plus spironolactone vs. Lisinopril plus spironolactone
干预措施: Aliskiren plus spironolactone vs. Lisinopril plus spironolactone (Drug)
结局指标
主要结局
Evaluate the superiority of aliskiren plus spironolactone combination over an lisinopril plus spironolactone combination in inhibiting the RAAS system among patients with diastolic HF.
时间窗: 8 weeks
Compare the clinical and biological benefit of RAAS system inhibition between aliskiren plus spironolactone and lisinopril plus spironolactone as measured by clinical indicators and serum biomarkers
时间窗: 8 weeks
Assess ethnicity-specific differences in the clinical response to either RAAS inhibition treatment between Mexican Americans and non-Hispanic whites.
时间窗: 8 weeks
Compare the baseline level of RAAS dysregulation between Mexican Americans and non-Hispanic whites with stable diastolic HF by measuring established biomarkers.
时间窗: 8 weeks
次要结局
未报告次要终点