Prospective Observational Study of the Sacubitril-Valsartan Treatment Effectiveness.
NCT ID: NCT04133428
Last Updated: 2020-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2019-04-04
2021-07-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 any contraindication for taking Sacubitril-Valsartan.
* Patients with EF \>40%.
18 Years
ALL
No
Sponsors
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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
OTHER
Responsible Party
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Principal Investigators
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Gonzalo Baron Esquivias
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Virgen Macarena
Locations
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Hospital Universitario Virgen Rocío
Seville, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FIS-SAC-2018-01
Identifier Type: -
Identifier Source: org_study_id
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