A Randomized, Double-blind, Active-controlled Study to Assess the Effect of Sacubitril/Valsartan Compared With Enalapril to Improve Erectile Function in Patients With Heart Failure With Reduced Ejection Fraction and Erectile Dysfunction
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Erectile Function Score Using Index of Erectile Function (IIEF-15)
研究概览
简要总结
The purpose of this study was to determine the effect of sacubitril/valsartan (LCZ696) vs. Enalapril on improvement in erectile function and ability in male patients with chronic heart failure with reduced ejection fraction and erectile dysfunction.
详细描述
The purpose of this study was to evaluate the effect of sacubitril/valsartan in improving erectile function in male patients with chronic heart failure (NYHA II) and reduced ejection fraction (HFrEF) and erectile dysfunction (ED). Data from this study was intended to provide a thorough understanding of the impact of sacubitril/valsartan on male sexual function and therefore quality of life.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of chronic heart failure (NYHA class II) and reduced ejection fraction (LVEF < 40%)
- •Patients must be living in a stable and sexually active heterosexual partnership for at least 6 months prior study start
- •Patients must have a mild to moderate erectile dysfunction (determined by using the IIEF-5 questionnaire)
- •Patients must be on an ACEI or an ARB at a stable dose for at least 4 weeks prior study start
- •Patients must be literate in German
排除标准
- •History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes, ACEIs, ARBs or NEP inhibitors, as well as known or suspected contraindications to the study drugs
- •Previous history of intolerance to recommended target doses of ACEIs or ARBs
- •Known history of angioedema
- •Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy)
- •Symptomatic hypotension
- •Impaired renal function
- •Penile anatomical defects and Peyronie's disease
- •Diabetes mellitus Type I or insulin-dependent Type II
- •Known prostate cancer
研究组 & 干预措施
LCZ696
LCZ696 200 mg (sacubitril/valsartan 97 mg/103 mg bid)
干预措施: LCZ696 (Drug)
LCZ696
LCZ696 200 mg (sacubitril/valsartan 97 mg/103 mg bid)
干预措施: LCZ696 matching placebo (Drug)
Enalapril
Enalapril 10 mg
干预措施: Enalapril matching placebo (Drug)
Enalapril
Enalapril 10 mg
干预措施: Enalapril (Drug)
结局指标
主要结局
Erectile Function Score Using Index of Erectile Function (IIEF-15)
时间窗: Week 12 (3 months)
The International Index of Erectile Function (IIEF-15) was used to assess erectile function in male patients with chronic heart failure. The IIEF-15 is a patient self-reported assessment of erectile dysfunction (ED) and consists of 15 questions assessing different aspects associated with ED. The domain evaluating erectile function consists of items 1, 2, 3, 4, 5 \& 15 and its total score was used here. Total score range =1-30. Items 1-5 is 6-point Likert-type scale from '0' (= No sexual activity), '1' (=Almost never or never) to '5' (= Almost always or always). Items 15 is 5-point Likert-type scale from '1' (= very low) to '5 '(= very high). Higher score indicates better outcome
次要结局
- Summary of Change From Baseline in NT-proBNP Levels(Baseline, Week 4, Week 12)
- Summary of Change From Baseline in Self-reported Frequency of Sexual Activity Per Week(Baseline, Week 4, Week 12)