Overview

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

Status:
Completed

Trial end date:
2020-02-27

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University Hospital, Montpellier

Treatments:

LCZ 696
Sacubitril and valsartan sodium hydrate drug combination
Valsartan

Criteria

Inclusion Criteria:

- Age is greater than or equal to 18 years

- Patient with chronic heart failure (LVEF ≤ 45%).

- Written informed consent

Exclusion Criteria:

- 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