Prospective Observational Study of the Sacubitril-Valsartan Treatment Effectiveness.
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|ClinicalTrials.gov Identifier: NCT04133428|
Recruitment Status : Recruiting
First Posted : October 21, 2019
Last Update Posted : October 21, 2019
|Condition or disease||Intervention/treatment|
|Heart Failure||Drug: Sacubitril-Valsartan|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Prospective Observational Study of the Sacubitril-Valsartan Treatment Effectiveness.|
|Actual Study Start Date :||December 15, 2018|
|Estimated Primary Completion Date :||December 15, 2019|
|Estimated Study Completion Date :||February 15, 2020|
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.
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.
- 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 ]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.
- Determine the microRNA genetic profile in heart failure. [ Time Frame: 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.
- 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 ]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. [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04133428
|Contact: Gonzalo Baron Esquivias||955 00 80 email@example.com|
|Hospital Universitario Virgen Rocío||Recruiting|
|Sevilla, Spain, 41009|
|Contact: Gonzalo Baron Esquivias 955 00 80 00 firstname.lastname@example.org|
|Principal Investigator:||Gonzalo Baron Esquivias||Hospital Universitario Virgen Macarena|