Prospective Observational Study of the Sacubitril-Valsartan Treatment Effectiveness.
Study Overview
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Sevilla, Spain, 41009
- Recruiting
- Hospital Universitario Virgen Rocio
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Contact:
- Gonzalo Baron Esquivias
- Phone Number: 955 00 80 00
- Email: gonzalo.baron.sspa@juntadeandalucia.es
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
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%.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Difference in the treatment response to Sacubitril-Valsartan depending on the ventricular dysfunction etiology.
Time Frame: Up to 6 months after the beginning of the Sacubitril-Valsartan treatment
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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.
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Up to 6 months after the beginning of the Sacubitril-Valsartan treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Determine the microRNA genetic profile in heart failure.
Time Frame: Up to 6 months after the beginning of the Sacubitril-Valsartan treatment
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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.
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Up to 6 months after the beginning of the Sacubitril-Valsartan treatment
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Evaluate the connection between the biomarkers levels in heart failure and the cardiac remodeling parameters.
Time Frame: Up to 6 months after the beginning of the Sacubitril-Valsartan treatment
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Demonstrate if there´s a possible relation between the biomarkers levels in heart failure and an improvement in the cardiac remodeling.
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Up to 6 months after the beginning of the Sacubitril-Valsartan treatment
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Study the levels of auricular natriuretic peptide (ANP), auricular natriuretic peptide type B (BNP), urocortin and type I-C terminal pro-collagen.
Time Frame: Up to 6 months after the beginning of the Sacubitril-Valsartan treatment
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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.
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Up to 6 months after the beginning of the Sacubitril-Valsartan treatment
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Collaborators and Investigators
Investigators
- Principal Investigator: Gonzalo Baron Esquivias, Hospital Universitario Virgen Macarena
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FIS-SAC-2018-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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