Prospective Observational Study of the Sacubitril-Valsartan Treatment Effectiveness.

NCT04133428 | Unknown

• 1 other identifier: FIS-SAC-2018-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Heart failure; Severe systolic disfunction; Sacubitril-Valsartan

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Determine the microRNA genetic profile in heart failure.

  Up to 6 months after the beginning of the Sacubitril-Valsartan treatment

Other Outcomes (2)

• 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

• 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 Arms (1)

Sacubitril-Valsartan cohort

Patients with severe systolic disfunction (left ventricle ejection fraction\<40%) heart failure that remain functional class II, III or IV after at least 3 months of optimal treatment and after being evaluated by the cardiologist by doing an echocardiography, blood test and clinical evaluation, start Sacubitril-Valsartan treatment.

Drug: Sacubitril-Valsartan

Interventions

Sacubitril-Valsartan DRUG

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.

Sacubitril-Valsartan cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients older than 18 years old, diagnosed with heart failure and EF ≤ 40%, that after being treated with optimal medical treatment for at least 3 months, remain in functional class II, III or IV. Being this the actual indication for Sacubitril-Valsartan. 100 consecutive patients will be included, 50 of whom with ischemic etiology of heart failure and 50 with non-ischemic, excluding patients with enolic etiology, any contraindication for the treatment intake and that have already been treated with Sacubitril-Valsartan.

You may qualify if:

• 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.

You may not qualify if:

• Patients with enolic etiology.
• Patients with any contraindication for taking Sacubitril-Valsartan.
• Patients with EF \>40%.

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (1)

Hospital Universitario Virgen Rocío

Seville, 41009, Spain

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

sacubitril and valsartan sodium hydrate drug combination

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Gonzalo Baron Esquivias

  Hospital Universitario Virgen Macarena

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gonzalo Baron Esquivias

CONTACT

955 00 80 00; gonzalo.baron.sspa@juntadeandalucia.es

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: October 21, 2019
• Study Start: April 4, 2019
• Primary Completion: April 4, 2021
• Study Completion: July 15, 2021
• Last Updated: February 7, 2020

Record last verified: 2019-10

Locations

ES (1)