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COmparing arNi and Ace For Improving Erectile Dysfunction in mEN With reduCed Ejection Fraction Heart Failure (CONFIDENCE-HF)

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ClinicalTrials.gov Identifier: NCT03917459
Recruitment Status : Not yet recruiting
First Posted : April 17, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The purpose of this study is to determine the effect of LCZ696 vs. Enalapril on improvement in erectile function and ability in male patients with chronic heart failure with reduced ejection fraction and erectile dysfunction

Condition or disease Intervention/treatment Phase
Heart Failure Heart Failure, Systolic Erectile Dysfunction Drug: LCZ696 Drug: Enalapril matching placebo Drug: Enalapril Drug: LCZ696 matching placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 15, 2019
Estimated Primary Completion Date : July 15, 2020
Estimated Study Completion Date : July 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LCZ696 Drug: LCZ696
LCZ696 50 mg = 24 mg/26 mg bid sacubitril/valsartan; 100 mg= 49 mg/51 mg bid sacubitril/valsartan or 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tablets

Drug: Enalapril matching placebo
Placebo to Enalapril 2.5 mg, 5 mg and 10 mg film-coated tablets

Active Comparator: Enalapril Drug: Enalapril
Enalapril 2.5 mg, 5 mg and 10 mg film-coated tablets

Drug: LCZ696 matching placebo
Placebo to LCZ696 50 mg = 24 mg/26 mg bid sacubitril/valsartan; 100 mg= 49 mg/51 mg bid sacubitril/valsartan or 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tabletsLCZ696 50 mg, 100 mg and 200 mg




Primary Outcome Measures :
  1. Erectile function score at 3 months [ Time Frame: 3 months ]
    The questionnaire International Index of Erectile Function (IIEF-15) is used to assess erectile function


Secondary Outcome Measures :
  1. Self-reported frequency of sexual activity per month at months 1 and 3 [ Time Frame: 1 months and 3 months ]
    Patient is asked to complete a diary assessing sexual activity on a weekly basis

  2. NT-proBNP levels at months 1 and 3 [ Time Frame: 1 month and 3 months ]
    Change in NT-proBNP compared to baseline will be assessed at month 1 and month 3



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • 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:

  • 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

Other protocol-defined inclusion/exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917459


Contacts
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Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Sponsors and Collaborators
Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03917459     History of Changes
Other Study ID Numbers: CLCZ696BDE03
2018-000220-33 ( EudraCT Number )
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
heart failure
systolic heart failure
heart failure with reduced ejection fraction
erectile dysfunction
Enalapril
Enalaprilat
LCZ696
Sacubitril/valsartan

Additional relevant MeSH terms:
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Heart Failure
Erectile Dysfunction
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Valsartan
Enalapril
Enalaprilat
LCZ 696
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors