Sacubitril-valsartan and Heart Failure Patients : the ENTRESTO-SAS Study

NCT02916160 | Completed Phase 4 DMC

• 1 other identifier: UF 9703
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 6

Brief Summary

Chronic Heart Failure (CHF) is a frequent pathology burdened with mortality and significant morbidity. Sleep apnea syndrome (SAS) is frequently associated with CHF in 20% to 75% of cases. Treatment of SAS is however inconsistently associated with a decline in the morbidity and mortality. To date, the CHF medical treatments have been reported to be inconsistently efficient in the treatment of SAS. SACUBITRIL-VALSARTAN (ENTRESTO®) is a new treatment of CHF recently indicated class I, level B in the recent European Society of Cardiology (ESC) guidelines 2016 on CHF. PARADIGM-HF trial demonstrated that morbidity and mortality can be improved with SACUBITRIL-VALSARTAN. In comparison to enalapril, it reduced the occurrence of cardiovascular death or hospitalisation for CHF by 20% with a 16% reduction in all-cause mortality. The purpose of the research is the evaluation of SACUBITRIL-VALSARTAN combination in CHF patients presenting sleep apnea syndrome. A three months real life observational trial is performed. A measure of the Apnea Hypopnea Index is realised before and after 3 months of SACUBITRIL-VALSARTAN treatment. A concomitant evaluation of cardiological and quality of life parameters is realized.

Conditions

Chronic Heart Failure; Sleep Apnea Syndrome

Keywords

Chronic Heart failure; Sleep Apnea Syndrome; Continuous Positive Airways Pressure; SACUBITRIL - VALSARTAN

Outcome Measures

Primary Outcomes (1)

• Changes in Apnea-Hypopnea Index as compared to baseline

  Changes in AHI as compared to baseline Measure of the apnea hypopnea index by a polygraphy performed before and after 3 months of treatment. The 2012 American Academy of Sleep Medicine recommendations are utilized in order to characterized apnea and hypopnea events, the central or obstructive or mixed phenotype

  0 month to 3 months

Secondary Outcomes (18)

• Subject Global Assessment

  0 month to 3 months

• NYHA Functional Class

  0 month to 3 months

• Heart Rhythm

  0 month to 3 months

• Systolic and diastolic Blood Pressure

  0 month to 3 months

• Renal function as compared to baseline (Estimated GFR (eGFR) will be calculated using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula

  0 month to 3 months

Study Arms (1)

SACUBITRIL - VALSARTAN

EXPERIMENTAL

SACUBITRIL - VALSARTAN (formerly LCZ696, ENTRESTO®) is a new treatment of HF recently indicated class I, level B in the recent ESC guidelines 2016 on HF. It combines inhibitory prodrug neprilysin and valsartan.

Drug: SACUBITRIL - VALSARTAN (formerly LCZ696, ENTRESTO®)

Interventions

SACUBITRIL - VALSARTAN (formerly LCZ696, ENTRESTO®) DRUG

SACUBITRIL - VALSARTAN (formerly LCZ696, ENTRESTO®) is a new treatment of HF recently indicated class I, level B in the recent ESC guidelines 2016 on HF. It combines inhibitory prodrug neprilysin and valsartan.

Also known as: LCZ696, ENTRESTO®

SACUBITRIL - VALSARTAN

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age is greater than or equal to 18 years
• Patient with chronic heart failure (LVEF ≤ 45%).
• Written informed consent

You may not qualify if:

• Renal insufficiency (GF\<30 milliliters/min)
• Pregnancy
• Allergy to one compound
• Personal history of angiooedema
• Hemodynamical instability
• Severe hepatopathy
• Current and not treated hyperkaliemia
• Prognosis \< 6months
• Current CPAP or ASV treatment for Sleep Apnea Syndrome

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (6)

CHU Bordeaux

Bordeaux, Pessac, 33604, France

Location

Pôle médical spécialisé MSP

Béziers, 34500, France

Location

CHU Béziers

Béziers, 34525, France

Location

Centre Hospitalier Universitaire de Montpellier

Montpellier, 34295, France

Location

CHU Nimes

Nîmes, 30029, France

Location

CHU Toulouse

Toulouse, 31059, France

Location

Related Publications (2)

• Jaffuel D, Molinari N, Berdague P, Pathak A, Galinier M, Dupuis M, Ricci JE, Mallet JP, Bourdin A, Roubille F. Impact of sacubitril-valsartan combination in patients with chronic heart failure and sleep apnoea syndrome: the ENTRESTO-SAS study design. ESC Heart Fail. 2018 Jun;5(3):222-230. doi: 10.1002/ehf2.12270. Epub 2018 Feb 22.

  PMID: 29469206 BACKGROUND

• Jaffuel D, Nogue E, Berdague P, Galinier M, Fournier P, Dupuis M, Georger F, Cadars MP, Ricci JE, Plouvier N, Picard F, Puel V, Mallet JP, Suehs CM, Molinari N, Bourdin A, Roubille F. Sacubitril-valsartan initiation in chronic heart failure patients impacts sleep apnea: the ENTRESTO-SAS study. ESC Heart Fail. 2021 Aug;8(4):2513-2526. doi: 10.1002/ehf2.13455. Epub 2021 Jun 8.

  PMID: 34102018 RESULT

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

sacubitril and valsartan sodium hydrate drug combination

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Arnaud BOURDIN, MD,PhD

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: September 27, 2016
• Study Start: September 22, 2016
• Primary Completion: February 27, 2020
• Study Completion: February 27, 2020
• Last Updated: June 15, 2021

Record last verified: 2020-07

Locations

FR (6)