Trial Outcomes & Findings for COmparing arNi and Ace For Improving Erectile Dysfunction in mEN With reduCed Ejection Fraction Heart Failure (NCT NCT03917459)

Last Updated: 2024-02-29

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

27 participants

Primary outcome timeframe

Week 12 (3 months)

Results posted on

2024-02-29

Participant Flow

A total of 13 patients were randomized to the LCZ696 group and 14 patients were randomized to the enalapril group. Of these, 12 patients in the LCZ696 group and 13 patients in the enalapril group completed the study. One patient from the LCZ696 group discontinued due to Adverse Event and 1 patient from the enalapril group discontinued due to subject decision.

Participant milestones

Participant milestones
Measure	LCZ696 LCZ696 200 mg (sacubitril/valsartan 97 mg/103 mg) bid	Enalapril Enalapril 10 mg bid
Overall Study STARTED	13	14
Overall Study COMPLETED	12	13
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	LCZ696 LCZ696 200 mg (sacubitril/valsartan 97 mg/103 mg) bid	Enalapril Enalapril 10 mg bid
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

COmparing arNi and Ace For Improving Erectile Dysfunction in mEN With reduCed Ejection Fraction Heart Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LCZ696 n=13 Participants LCZ696 200 mg (sacubitril/valsartan 97 mg/103 mg) bid	Enalapril n=14 Participants Enalapril 10 mg bid	Total n=27 Participants Total of all reporting groups
Age, Continuous	63.5 Years STANDARD_DEVIATION 9.18 • n=5 Participants	66.5 Years STANDARD_DEVIATION 7.80 • n=7 Participants	65.0 Years STANDARD_DEVIATION 8.47 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 12 (3 months)

Population: All participants who received at least one dose of study treatment and had a valid assessment of the outcome measure

Outcome measures

Outcome measures
Measure	LCZ696 n=12 Participants LCZ696 200 mg (sacubitril/valsartan 97 mg/103 mg) bid	Enalapril n=13 Participants Enalapril 10 mg bid
Erectile Function Score Using Index of Erectile Function (IIEF-15)	15.1 Scores on a scale Standard Error 2.15	12.2 Scores on a scale Standard Error 2.00

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 12

Population: Full Analysis Set, including all participants who received at least one dose of study treatment

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

Outcome measures

Outcome measures
Measure	LCZ696 n=13 Participants LCZ696 200 mg (sacubitril/valsartan 97 mg/103 mg) bid	Enalapril n=14 Participants Enalapril 10 mg bid
Summary of Change From Baseline in Self-reported Frequency of Sexual Activity Per Week Week 4:	-1.6 Activities per week. Standard Deviation 1.59	-1.1 Activities per week. Standard Deviation 1.97
Summary of Change From Baseline in Self-reported Frequency of Sexual Activity Per Week Week 12:	-1.4 Activities per week. Standard Deviation 3.13	-2.0 Activities per week. Standard Deviation 3.07

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 12

Population: Full Analysis Set, including all participants who received at least one dose of study treatment

Change in n-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels compared to baseline assessed at Week 4 and Week 12

Outcome measures

Outcome measures
Measure	LCZ696 n=13 Participants LCZ696 200 mg (sacubitril/valsartan 97 mg/103 mg) bid	Enalapril n=14 Participants Enalapril 10 mg bid
Summary of Change From Baseline in NT-proBNP Levels Week 4	-369.00 pg/mL Interval -521.0 to -68.0	-43.50 pg/mL Interval -123.5 to 363.0
Summary of Change From Baseline in NT-proBNP Levels Week 12	-208.50 pg/mL Interval -1469.0 to 416.5	-189.00 pg/mL Interval -394.0 to 10.0

Adverse Events

LCZ696

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Enalapril

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	LCZ696 n=13 participants at risk LCZ696 200 mg (sacubitril/valsartan 97 mg/103 mg) bid	Enalapril n=14 participants at risk Enalapril 10 mg bid
Cardiac disorders Cardiac arrest	0.00% 0/13 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 1 month Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	7.1% 1/14 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 1 month Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Vascular disorders Hypertensive crisis	7.7% 1/13 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 1 month Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/14 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 1 month Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.

Other adverse events

Other adverse events
Measure	LCZ696 n=13 participants at risk LCZ696 200 mg (sacubitril/valsartan 97 mg/103 mg) bid	Enalapril n=14 participants at risk Enalapril 10 mg bid
Gastrointestinal disorders Dental caries	7.7% 1/13 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 1 month Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/14 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 1 month Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Gastrointestinal disorders Toothache	7.7% 1/13 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 1 month Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/14 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 1 month Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
General disorders Oedema peripheral	0.00% 0/13 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 1 month Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	7.1% 1/14 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 1 month Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Infections and infestations Bronchitis	7.7% 1/13 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 1 month Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/14 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 1 month Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Investigations Blood potassium decreased	7.7% 1/13 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 1 month Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/14 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 1 month Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Fluid retention	0.00% 0/13 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 1 month Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	7.1% 1/14 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 1 month Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Metabolism and nutrition disorders Gout	0.00% 0/13 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 1 month Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	7.1% 1/14 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 1 month Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Musculoskeletal and connective tissue disorders Arthralgia	7.7% 1/13 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 1 month Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/14 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 1 month Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/13 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 1 month Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	7.1% 1/14 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 1 month Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Vascular disorders Haematoma	7.7% 1/13 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 1 month Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	0.00% 0/14 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 1 month Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
Vascular disorders Hypotension	7.7% 1/13 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 1 month Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.	7.1% 1/14 • Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 1 month Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER