Back to results" Evaluation of Safety and Efficacy of Empagliflozin and Sacubitril/Valsartan for CHF With Reduced Ejection Fraction in ACHD "
Primary Purpose
Congenital Heart Disease, Heart Failure, Heart Failure With Reduced Ejection Fraction
Status
Not yet recruiting
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Sacubitril 49 MG / Valsartan 51 MG [Entresto] BID
Empagliflozin 10 MG OD
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Heart Disease focused on measuring Adult congenital heart disease, Heart Failure with Reduced Ejection Fraction, Empagliflozin, Sacubitril-valsartan
Eligibility Criteria
Inclusion Criteria:
- NYHA functional class II-IV
- Diagnosis of CHD: repaired, palliated or without previous treatment
- Systemic ventricular ejection fraction <40%
- Without unplanned hospital admissions within 3 months prior to randomization
- The participant is willing and able to give informed consent for participation in the study
Exclusion Criteria:
- Pregnant and postpartum women
- Breastfeeding women during the study
- History of drug allergy to any SGLT-2 inhibitor and/or sacubitril/valsartan
- Previous administration of a drug regimen including an SGLT-2 inhibitor and/or sacubitril/valsartan
- Intellectual or physical disability that impedes the subject to perform the 6 minute walk-test
- Patients with any contraindication to SGLT-2 inhibitor and/or sacubitril/valsartan
- Medical history of myocardial infarction, cardiac surgery or fulminant myocarditis within the last three months
- Medical history of type 1 diabetes mellitus
- Medical history of hypertensive crisis in the previous 6-months
- Medical history of cardiogenic shock or heart failure decompensation in the previous 6-months
- Medical history of heart transplantation
Sites / Locations
- National Institute of Cardiology Ignacio Chavez
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Conventional treatment of Heart failure and Sacubitril/Valsartan
Conventional treatment plus Empagliflozin and Sacubitril/valsartan
Conventional treatment plus Empagliflozin
Arm Description
Patients will receive conventional treatment consisting of spironolactone 25 mg orally every 24 hours (maximum dose 50 mg every 24 hours) or eplerenone 25 mg orally every 24 hours (maximum dose 50 mg every 24 hours); beta-blockers: bisoprolol 1.5 mg orally every 24 hours (maximum dose 10 mg every 24 hours) or metoprolol succinate 12.5 mg every 24 hours orally (maximum dose 200 mg every 24 hours) or carvedilol 3125 mg every 24 hours (maximum dose 25 mg every 24 hours) or ivabradine 5 mg every 12 hours (maximum dose 7.5 mg every 12 hours); diuretics: furosemide 20 to 400 mg orally every 24 hours or bumetanide 1 to 15 mg orally every 24 hours and/or chlorthalidone 25 mg orally every 24 hours. Additionally, patients will receive Sacubitril/Valsartan, with the intention to titrate up to 49 mg/51 mg orally every 12 hours.
Patients will receive conventional treatment consisting of spironolactone 25 mg orally every 24 hours (maximum dose 50 mg every 24 hours) or eplerenone 25 mg orally every 24 hours (maximum dose 50 mg every 24 hours); beta-blockers: bisoprolol 1.5 mg orally every 24 hours (maximum dose 10 mg every 24 hours) or metoprolol succinate 12.5 mg every 24 hours orally (maximum dose 200 mg every 24 hours) or carvedilol 3125 mg every 24 hours (maximum dose 25 mg every 24 hours) or ivabradine 5 mg every 12 hours (maximum dose 7.5 mg every 12 hours); diuretics: furosemide 20 to 400 mg orally every 24 hours or bumetanide 1 to 15 mg orally every 24 hours and/or chlorthalidone 25 mg orally every 24 hours. Additionally, patients will use Sacubitril/Valsartan, with the intention to titrate up to 49 mg/51 mg orally every 12 hours and Empagliflozin 10 mg orally every 24 hours.
Patients will receive conventional treatment consisting of spironolactone 25 mg orally every 24 hours (maximum dose 50 mg every 24 hours) or eplerenone 25 mg orally every 24 hours (maximum dose 50 mg every 24 hours); beta-blockers: bisoprolol 1.5 mg orally every 24 hours (maximum dose 10 mg every 24 hours) or metoprolol succinate 12.5 mg every 24 hours orally (maximum dose 200 mg every 24 hours) or carvedilol 3125 mg every 24 hours (maximum dose 25 mg every 24 hours) or ivabradine 5 mg every 12 hours (maximum dose 7.5 mg every 12 hours); diuretics: furosemide 20 to 400 mg orally every 24 hours or bumetanide 1 to 15 mg orally every 24 hours and/or chlorthalidone 25 mg orally every 24 hours. Additionally, patients will use Empagliflozin 10 mg orally every 24 hours.
Outcomes
Primary Outcome Measures
3D echocardiographic systemic ventricular end-diastolic volume index
Change of 8.2 ml or greater in systemic ventricular end-diastolic volume index measured by 3D echocardiogram.
3D echocardiographic systemic ventricular end-systolic volume index
Change of 6.0 ml or greater in end-systolic volume index measured by 3D echocardiogram.
Secondary Outcome Measures
Functional class
A clinically relevant change of greater than or equal to 5 points from baseline score in the functional class measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). This questionnaire evaluates 23 elements and is divided into 7 different domains. The score will interpreted as follows:
0-24 points: very poor to poor 25-49 points: poor to fair 50-74 points: fair to good 75-100 points: good to excellent
Pulmonary congestion
Change in pulmonary B score measured by the quantification and characteristics of B-lines seen with pulmonary ultrasound assessing 8 regions total using the following scoring system:
0 points: less than 3 B-lines per zone
1 point: greater than or equal to 3 B-lines per zone
6-minute walking test
Difference in meters walked in the 6-minute walking test.
Echocardiographic ejection fraction from the systemic ventricle
A change in the percentage of ejection fraction from the systemic ventricle measured by echocardiogram.
Echocardiographic longitudinal overall strain
A change in the percentage of longitudinal overall strain measured by echocardiogram at baseline and after treatment.
NT-proBNP
Change in NT-proBNP values.
Systemic venous congestion
Change in VExUS grading system measured by the diameter of the inferior vena cava in cm and Doppler pattern abnormalities on hepatic, portal and intra-renal veins using the following scoring system:
No congestion (0): IVC less than 2 cm Mild (1): IVC greater than or equal to 2cm and any normal or mildly abnormal patterns Moderate (2): IVC greater than or equal to 2cm and ONE severely abnormal pattern Severe (3): IVC greater than or equal to 2 cm and more than or equal to TWO severely abnormal patterns
Full Information
NCT ID
NCT05580510
First Posted
October 4, 2022
Last Updated
October 31, 2022
Sponsor
Instituto Nacional de Cardiologia Ignacio Chavez
Collaborators
Boehringer Ingelheim laboratory
1. Study Identification
Unique Protocol Identification Number
NCT05580510
Brief Title
" Evaluation of Safety and Efficacy of Empagliflozin and Sacubitril/Valsartan for CHF With Reduced Ejection Fraction in ACHD "
Official Title
"An Open-label Clinical Trial to Evaluate the Safety and Efficacy of Empagliflozin and Sacubitril/Valsartan in Adult Patients With Chronic Heart Failure With Reduced Ejection Fraction Associated With Congenital Heart Disease"
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 6, 2023 (Anticipated)
Primary Completion Date
July 28, 2023 (Anticipated)
Study Completion Date
March 29, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Nacional de Cardiologia Ignacio Chavez
Collaborators
Boehringer Ingelheim laboratory
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The treatment of adult patients with congenital heart disease (ACHD) and heart failure (HF) represents a great challenge since, to date, there is no standardized guideline for this specific population. Although new treatments for HF have been proposed, such as Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors and neprilisin and angiotensin receptor inhibitors, the benefit of these drugs in patients with HF associated with congenital heart disease in adults has not yet been demonstrated. For this reason, this study pretends to evaluate the efficacy of empagliflozin and sacubitril/valsartan in this population.
Detailed Description
A 12-week randomized, open label, active-controlled trial to explore the effects of once-daily empagliflozin 10 mg and/or sacutril/valsartan 49 mg/51 mg in the reduction of systemic ventricular volumes (end-diastolic and end-systolic) in adult patients with HF associated with congenital heart disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease, Heart Failure, Heart Failure With Reduced Ejection Fraction
Keywords
Adult congenital heart disease, Heart Failure with Reduced Ejection Fraction, Empagliflozin, Sacubitril-valsartan
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Open-label randomized clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional treatment of Heart failure and Sacubitril/Valsartan
Arm Type
Active Comparator
Arm Description
Patients will receive conventional treatment consisting of spironolactone 25 mg orally every 24 hours (maximum dose 50 mg every 24 hours) or eplerenone 25 mg orally every 24 hours (maximum dose 50 mg every 24 hours); beta-blockers: bisoprolol 1.5 mg orally every 24 hours (maximum dose 10 mg every 24 hours) or metoprolol succinate 12.5 mg every 24 hours orally (maximum dose 200 mg every 24 hours) or carvedilol 3125 mg every 24 hours (maximum dose 25 mg every 24 hours) or ivabradine 5 mg every 12 hours (maximum dose 7.5 mg every 12 hours); diuretics: furosemide 20 to 400 mg orally every 24 hours or bumetanide 1 to 15 mg orally every 24 hours and/or chlorthalidone 25 mg orally every 24 hours.
Additionally, patients will receive Sacubitril/Valsartan, with the intention to titrate up to 49 mg/51 mg orally every 12 hours.
Arm Title
Conventional treatment plus Empagliflozin and Sacubitril/valsartan
Arm Type
Experimental
Arm Description
Patients will receive conventional treatment consisting of spironolactone 25 mg orally every 24 hours (maximum dose 50 mg every 24 hours) or eplerenone 25 mg orally every 24 hours (maximum dose 50 mg every 24 hours); beta-blockers: bisoprolol 1.5 mg orally every 24 hours (maximum dose 10 mg every 24 hours) or metoprolol succinate 12.5 mg every 24 hours orally (maximum dose 200 mg every 24 hours) or carvedilol 3125 mg every 24 hours (maximum dose 25 mg every 24 hours) or ivabradine 5 mg every 12 hours (maximum dose 7.5 mg every 12 hours); diuretics: furosemide 20 to 400 mg orally every 24 hours or bumetanide 1 to 15 mg orally every 24 hours and/or chlorthalidone 25 mg orally every 24 hours.
Additionally, patients will use Sacubitril/Valsartan, with the intention to titrate up to 49 mg/51 mg orally every 12 hours and Empagliflozin 10 mg orally every 24 hours.
Arm Title
Conventional treatment plus Empagliflozin
Arm Type
Experimental
Arm Description
Patients will receive conventional treatment consisting of spironolactone 25 mg orally every 24 hours (maximum dose 50 mg every 24 hours) or eplerenone 25 mg orally every 24 hours (maximum dose 50 mg every 24 hours); beta-blockers: bisoprolol 1.5 mg orally every 24 hours (maximum dose 10 mg every 24 hours) or metoprolol succinate 12.5 mg every 24 hours orally (maximum dose 200 mg every 24 hours) or carvedilol 3125 mg every 24 hours (maximum dose 25 mg every 24 hours) or ivabradine 5 mg every 12 hours (maximum dose 7.5 mg every 12 hours); diuretics: furosemide 20 to 400 mg orally every 24 hours or bumetanide 1 to 15 mg orally every 24 hours and/or chlorthalidone 25 mg orally every 24 hours.
Additionally, patients will use Empagliflozin 10 mg orally every 24 hours.
Intervention Type
Drug
Intervention Name(s)
Sacubitril 49 MG / Valsartan 51 MG [Entresto] BID
Other Intervention Name(s)
Entresto
Intervention Description
This group of patients will receive the conventional treatment of heart failure according to the "2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure" and Sacubitril/Valsartan as an active comparator.
Intervention Type
Drug
Intervention Name(s)
Empagliflozin 10 MG OD
Other Intervention Name(s)
Jardiance
Intervention Description
This group of patients will receive the conventional treatment of heart failure according to the "2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure" and Empagliflozin as an experimental drug.
Primary Outcome Measure Information:
Title
3D echocardiographic systemic ventricular end-diastolic volume index
Description
Change of 8.2 ml or greater in systemic ventricular end-diastolic volume index measured by 3D echocardiogram.
Time Frame
Twelve weeks
Title
3D echocardiographic systemic ventricular end-systolic volume index
Description
Change of 6.0 ml or greater in end-systolic volume index measured by 3D echocardiogram.
Time Frame
Twelve weeks
Secondary Outcome Measure Information:
Title
Functional class
Description
A clinically relevant change of greater than or equal to 5 points from baseline score in the functional class measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). This questionnaire evaluates 23 elements and is divided into 7 different domains. The score will interpreted as follows:
0-24 points: very poor to poor 25-49 points: poor to fair 50-74 points: fair to good 75-100 points: good to excellent
Time Frame
Twelve weeks
Title
Pulmonary congestion
Description
Change in pulmonary B score measured by the quantification and characteristics of B-lines seen with pulmonary ultrasound assessing 8 regions total using the following scoring system:
0 points: less than 3 B-lines per zone
1 point: greater than or equal to 3 B-lines per zone
Time Frame
Twelve weeks
Title
6-minute walking test
Description
Difference in meters walked in the 6-minute walking test.
Time Frame
Twelve weeks
Title
Echocardiographic ejection fraction from the systemic ventricle
Description
A change in the percentage of ejection fraction from the systemic ventricle measured by echocardiogram.
Time Frame
Twelve weeks
Title
Echocardiographic longitudinal overall strain
Description
A change in the percentage of longitudinal overall strain measured by echocardiogram at baseline and after treatment.
Time Frame
Twelve weeks
Title
NT-proBNP
Description
Change in NT-proBNP values.
Time Frame
Twelve weeks
Title
Systemic venous congestion
Description
Change in VExUS grading system measured by the diameter of the inferior vena cava in cm and Doppler pattern abnormalities on hepatic, portal and intra-renal veins using the following scoring system:
No congestion (0): IVC less than 2 cm Mild (1): IVC greater than or equal to 2cm and any normal or mildly abnormal patterns Moderate (2): IVC greater than or equal to 2cm and ONE severely abnormal pattern Severe (3): IVC greater than or equal to 2 cm and more than or equal to TWO severely abnormal patterns
Time Frame
Twelve weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
NYHA functional class II-IV
Diagnosis of CHD: repaired, palliated or without previous treatment
Systemic ventricular ejection fraction <40%
Without unplanned hospital admissions within 3 months prior to randomization
The participant is willing and able to give informed consent for participation in the study
Exclusion Criteria:
Pregnant and postpartum women
Breastfeeding women during the study
History of drug allergy to any SGLT-2 inhibitor and/or sacubitril/valsartan
Previous administration of a drug regimen including an SGLT-2 inhibitor and/or sacubitril/valsartan
Intellectual or physical disability that impedes the subject to perform the 6 minute walk-test
Patients with any contraindication to SGLT-2 inhibitor and/or sacubitril/valsartan
Medical history of myocardial infarction, cardiac surgery or fulminant myocarditis within the last three months
Medical history of type 1 diabetes mellitus
Medical history of hypertensive crisis in the previous 6-months
Medical history of cardiogenic shock or heart failure decompensation in the previous 6-months
Medical history of heart transplantation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edgar Garcia-Cruz, MD
Phone
+ 52 55 4340 7152
Email
Edgar.garcia@cardiologia.org.mx
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Manzur-Sandoval, MD
Phone
+ 52 55 1291 1916
Email
drdanielmanzur@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edgar Garcia-Cruz, MD
Organizational Affiliation
National Institute of Cardiology Ignacio Chavez
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Montserrat Villalobos-Pedroza, MD
Organizational Affiliation
National Institute of Cardiology Ignacio Chavez
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gian Jimenez-Rodriguez, MD
Organizational Affiliation
National Institute of Cardiology Ignacio Chávez
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Carlos Guizar-Sanchez, MD
Organizational Affiliation
National Institute of Cardiology Ignacio Chávez
Official's Role
Study Director
Facility Information:
Facility Name
National Institute of Cardiology Ignacio Chavez
City
Mexico City
ZIP/Postal Code
14080
Country
Mexico
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edgar García-Cruz, MD
Phone
+ 52 55 4340 7152
Email
Edgar.garcia@cardiologia.org.mx
First Name & Middle Initial & Last Name & Degree
Daniel Manzur-Sandoval, MD
Phone
+ 52 55 1291 1916
Email
drdanielmanzur@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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" Evaluation of Safety and Efficacy of Empagliflozin and Sacubitril/Valsartan for CHF With Reduced Ejection Fraction in ACHD "
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