Heart FailurePhase 3CONFIDENCE-HFNCT03917459
COmparing arNi and Ace For Improving Erectile Dysfunction in mEN With reduCed Ejection Fraction Heart Failure
A Phase 3 study testing LCZ696 and Enalapril in people with Heart Failure and Heart Failure, Systolic, run by Novartis Pharmaceuticals at 13 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Heart Failure, Heart Failure, Systolic, Erectile Dysfunction
- What is being tested?
- LCZ696 and Enalapril
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 13 sitesGermany
- Study dates
- 16 Apr 2019to 25 May 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Penile anatomical defects and Peyronie's disease
- Diabetes mellitus Type I or insulin-dependent Type II
- Known prostate cancer
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Germany13 sites
Novartis Investigative Site
Bamberg, 96049
Novartis Investigative Site
Berlin, 10367
Novartis Investigative Site
Berlin, 10789
Novartis Investigative Site
Böhlen, 04564
Novartis Investigative Site
Buchholz in der Nordheide, 21244
Novartis Investigative Site
Frankfurt, 60594
Novartis Investigative Site
Hanover, Lower Saxony, 30159
Novartis Investigative Site
Jerichow, 39319
Novartis Investigative Site
Markkleeberg, 04416
Novartis Investigative Site
Nuremberg, 90402
Novartis Investigative Site
Rostock, 18107
Novartis Investigative Site
Ulm, 89077
Novartis Investigative Site
Wermsdorf, 04779
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Heart Failure, Heart Failure, Systolic, Erectile Dysfunction
- Being tested
- LCZ696, Enalapril matching placebo, Enalapril, LCZ696 matching placebo
- Keywords
- heart failure, systolic heart failure, heart failure with reduced ejection fraction, erectile dysfunction, Enalapril, Enalaprilat, LCZ696, Sacubitril/valsartan
- Medical subject headings
- Heart Failure, Heart Failure, Systolic, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCZ696Drug
sacubitril/valsartan 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tablets
Enalapril matching placeboDrug
Placebo to Enalapril 10 mg film-coated tablets
EnalaprilDrug
Enalapril 10 mg film-coated tablets
LCZ696 matching placeboDrug
Placebo to LCZ696 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tablets
| Study group | Role | What they receive |
|---|---|---|
| LCZ696 | Experimental | LCZ696 200 mg (sacubitril/valsartan 97 mg/103 mg bid) Receives: Drug: LCZ696; Drug: LCZ696 matching placebo |
| Enalapril | Active comparator | Enalapril 10 mg Receives: Drug: Enalapril matching placebo; Drug: Enalapril |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 12 (3 months)
Secondary outcomes (2)
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
Measured: 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
Measured: Baseline, Week 4, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start16 Apr 2019
- Primary completion25 May 2021
- Study completion25 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917459
- Sponsor's protocol ID
- CLCZ696BDE03
- Other IDs
- 2018-000220-33, 2018
- Acronym
- CONFIDENCE-HF
- Status last verified
- Feb 2024
- First submitted
- 9 Apr 2019
- Last updated
- 29 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03917459
- Acronym / sponsor ID
- CONFIDENCE-HF / CLCZ696BDE03
- Conditions
- Heart Failure, Heart Failure, Systolic, Erectile Dysfunction
- Keywords
- heart failure, systolic heart failure, heart failure with reduced ejection fraction, erectile dysfunction, Enalapril, Enalaprilat, LCZ696, Sacubitril/valsartan
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 25 May 2021 (actual)
- Study completion
- 25 May 2021 (actual)
- First posted
- 17 Apr 2019 (actual)
- Results
- Posted 8 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LCZ696 | Experimental | Drug: LCZ696, Drug: LCZ696 matching placeboLCZ696 200 mg (sacubitril/valsartan 97 mg/103 mg bid) |
| Enalapril | Active comparator | Drug: Enalapril matching placebo, Drug: EnalaprilEnalapril 10 mg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LCZ696sacubitril/valsartan 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tablets | Drug | LCZ696 |
| Enalapril matching placeboPlacebo to Enalapril 10 mg film-coated tablets | Drug | Enalapril |
| EnalaprilEnalapril 10 mg film-coated tablets | Drug | Enalapril |
| LCZ696 matching placeboPlacebo to LCZ696 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tablets | Drug | LCZ696 |
Primary outcome
Erectile Function Score Using Index of Erectile Function (IIEF-15)
Time frame: 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
2 secondary outcomes
Summary of Change From Baseline in Self-reported Frequency of Sexual Activity Per Week
Time frame: Baseline, Week 4, Week 12
Summary of Change From Baseline in NT-proBNP Levels
Time frame: Baseline, Week 4, Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Plain Language Trial SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LCZ696 and Enalapril in people with Heart Failure and Heart Failure, Systolic, run by Novartis Pharmaceuticals at 13 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erectile Function Score Using Index of Erectile Function (IIEF-15) (time frame: Week 12 (3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.