Prospective Observational Study of the Sacubitril-Valsartan Treatment Effectiveness.

Heart Failure Clinical Trial

Official title:

Prospective Observational Study of the Sacubitril-Valsartan Treatment Effectiveness.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04133428
• Other study ID #: FIS-SAC-2018-01
• Status: Recruiting
• Start date: April 4, 2019
• Est. completion date: July 15, 2021

Study information

• Verified date: October 2019
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: Gonzalo Baron Esquivias
• Phone: 955 00 80 00
• Email: gonzalo.baron.sspa[@]juntadeandalucia.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 15, 2021
• Est. primary completion date: April 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Sacubitril-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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen Rocío	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluate the connection between the biomarkers levels in heart failure and the cardiac remodeling parameters.	Demonstrate if there´s a possible relation between the biomarkers levels in heart failure and an improvement in the cardiac remodeling.	Up to 6 months after the beginning of the Sacubitril-Valsartan treatment
Other	Study the levels of auricular natriuretic peptide (ANP), auricular natriuretic peptide type B (BNP), urocortin and type I-C terminal pro-collagen.	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.	Up to 6 months after the beginning of the Sacubitril-Valsartan treatment
Primary	Difference in the treatment response to Sacubitril-Valsartan depending on the ventricular dysfunction etiology.	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.	Up to 6 months after the beginning of the Sacubitril-Valsartan treatment
Secondary	Determine the microRNA genetic profile in heart failure.	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.	Up to 6 months after the beginning of the Sacubitril-Valsartan treatment