Heart Failure
Conditions
Keywords
Heart failure, Severe systolic disfunction, Sacubitril-Valsartan
Brief summary
The aim of this prospective study is to demonstrate if there is any difference in the treatment response to Sacubitril-Valsartan depending on the ventricular disfunction ethiology in patients with severe systolic disfunction heart failure.
Interventions
DRUGSacubitril-Valsartan
Evaluation of the Sacubitril-Valsartan treatment effectiveness. As there are three possible doses, during the first 30 days of treatment 3 evaluations will be carried out (every 10 days) for dose titration based on safety and tolerability as well as a blood test the 30rd day of treatment. Afterwards the patient will be evaluated after 3 and 6 months of treatment with a blood test and in the final visit (6 months) an echocardiography will be carried out and the final clinical evaluation will be made.
Sponsors
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients older than 18 years old. * Ejection fraction (EF) ≤ 40%. * Treated with optimal medical treatment for at least 3 months and remained in functional class II, III or IV. * Patients with ischemic or non ischemic etiology.
Exclusion criteria
* Patients with enolic etiology. * Patients with any contraindication for taking Sacubitril-Valsartan. * Patients with EF \>40%.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in the treatment response to Sacubitril-Valsartan depending on the ventricular dysfunction etiology. | Up to 6 months after the beginning of the Sacubitril-Valsartan treatment | Verify if there is any difference in the response to the treatment with Sacubitril-Valsartan depending on the ventricular dysfunction etiology, ischemic or non-ischemic (idiopathic/familiar,toxic, volume overload,etc) excluding enolic, of patients with severe systolic heart failure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine the microRNA genetic profile in heart failure. | Up to 6 months after the beginning of the Sacubitril-Valsartan treatment | Study of the microRNA genetic profile in heart failure as an indicator of the cardiac remodeling process and see its response and changes after undergoing Sacubitril-Valsartan treatment. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the connection between the biomarkers levels in heart failure and the cardiac remodeling parameters. | Up to 6 months after the beginning of the Sacubitril-Valsartan treatment | Demonstrate if there´s a possible relation between the biomarkers levels in heart failure and an improvement in the cardiac remodeling. |
| Study the levels of auricular natriuretic peptide (ANP), auricular natriuretic peptide type B (BNP), urocortin and type I-C terminal pro-collagen. | Up to 6 months after the beginning of the Sacubitril-Valsartan treatment | Study the levels of ANP, BNP and urocortin as cardioprotective molecules as well as type I-C terminal pro-collagen as measurement of peripheral blood fibrosis. |
Countries
Spain
Contacts
Primary ContactGonzalo Baron Esquivias
Outcome results
None listed