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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
27
Novartis Investigative Site
Hanover, Lower Saxony, Germany
Novartis Investigative Site
Bamberg, Germany
Novartis Investigative Site
Berlin, Germany
Erectile Function Score Using Index of Erectile Function (IIEF-15)
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
Time frame: Week 12 (3 months)
Summary of Change From Baseline in Self-reported Frequency of Sexual Activity Per Week
Assessment of early-onset effect and end of study effect, regarding improvement in sexual activity, using patient's self-reported frequency of sexual activity per week. Patient was asked to complete a diary assessing sexual activity on a weekly basis
Time frame: Baseline, Week 4, Week 12
Summary of Change From Baseline in NT-proBNP Levels
Change in n-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels compared to baseline assessed at Week 4 and Week 12
Time frame: Baseline, Week 4, Week 12
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Placebo to LCZ696 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tablets
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Böhlen, Germany
Novartis Investigative Site
Buchholz in der Nordheide, Germany
Novartis Investigative Site
Frankfurt, Germany
Novartis Investigative Site
Jerichow, Germany
Novartis Investigative Site
Markkleeberg, Germany
Novartis Investigative Site
Nuremberg, Germany
...and 3 more locations