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

Primary Purpose

Heart Failure, Heart Failure, Systolic, Erectile Dysfunction

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
LCZ696
Enalapril matching placebo
Enalapril
LCZ696 matching placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring heart failure, systolic heart failure, heart failure with reduced ejection fraction, erectile dysfunction, Enalapril, Enalaprilat, LCZ696, Sacubitril/valsartan

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LCZ696

Enalapril

Arm Description

Outcomes

Primary Outcome Measures

Erectile function score at 3 months
The questionnaire International Index of Erectile Function (IIEF-15) is used to assess erectile function

Secondary Outcome Measures

Self-reported frequency of sexual activity per month at months 1 and 3
Patient is asked to complete a diary assessing sexual activity on a weekly basis
NT-proBNP levels at months 1 and 3
Change in NT-proBNP compared to baseline will be assessed at month 1 and month 3

Full Information

First Posted
April 9, 2019
Last Updated
July 7, 2021
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03917459
Brief Title
COmparing arNi and Ace For Improving Erectile Dysfunction in mEN With reduCed Ejection Fraction Heart Failure
Acronym
CONFIDENCE-HF
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 16, 2019 (Actual)
Primary Completion Date
May 25, 2021 (Actual)
Study Completion Date
May 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LCZ696
Arm Type
Experimental
Arm Title
Enalapril
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
LCZ696
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Enalapril matching placebo
Intervention Description
Placebo to Enalapril 2.5 mg, 5 mg and 10 mg film-coated tablets
Intervention Type
Drug
Intervention Name(s)
Enalapril
Intervention Description
Enalapril 2.5 mg, 5 mg and 10 mg film-coated tablets
Intervention Type
Drug
Intervention Name(s)
LCZ696 matching placebo
Intervention Description
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 Measure Information:
Title
Erectile function score at 3 months
Description
The questionnaire International Index of Erectile Function (IIEF-15) is used to assess erectile function
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Self-reported frequency of sexual activity per month at months 1 and 3
Description
Patient is asked to complete a diary assessing sexual activity on a weekly basis
Time Frame
1 months and 3 months
Title
NT-proBNP levels at months 1 and 3
Description
Change in NT-proBNP compared to baseline will be assessed at month 1 and month 3
Time Frame
1 month and 3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Novartis Investigative Site
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30159
Country
Germany
Facility Name
Novartis Investigative Site
City
Bamberg
ZIP/Postal Code
96049
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10367
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10789
Country
Germany
Facility Name
Novartis Investigative Site
City
Boehlen
ZIP/Postal Code
04564
Country
Germany
Facility Name
Novartis Investigative Site
City
Buchholz in der Nordheide
ZIP/Postal Code
21244
Country
Germany
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60594
Country
Germany
Facility Name
Novartis Investigative Site
City
Jerichow
ZIP/Postal Code
39319
Country
Germany
Facility Name
Novartis Investigative Site
City
Markkleeberg
ZIP/Postal Code
04416
Country
Germany
Facility Name
Novartis Investigative Site
City
Nuremberg
ZIP/Postal Code
90402
Country
Germany
Facility Name
Novartis Investigative Site
City
Rostock
ZIP/Postal Code
18107
Country
Germany
Facility Name
Novartis Investigative Site
City
Ulm
ZIP/Postal Code
89077
Country
Germany
Facility Name
Novartis Investigative Site
City
Wermsdorf
ZIP/Postal Code
04779
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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