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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
Sponsor:
Information provided by (Responsible Party):
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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.

Condition or disease Intervention/treatment
Heart Failure Drug: Sacubitril-Valsartan

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Valsartan

Group/Cohort Intervention/treatment
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

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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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%.

Information from the National Library of Medicine

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


Contacts
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Contact: Gonzalo Baron Esquivias 955 00 80 00 gonzalo.baron.sspa@juntadeandalucia.es

Locations
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Spain
Hospital Universitario Virgen Rocío Recruiting
Sevilla, Spain, 41009
Contact: Gonzalo Baron Esquivias    955 00 80 00    gonzalo.baron.sspa@juntadeandalucia.es   
Sponsors and Collaborators
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Investigators
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Principal Investigator: Gonzalo Baron Esquivias Hospital Universitario Virgen Macarena

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Responsible Party: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier: NCT04133428     History of Changes
Other Study ID Numbers: FIS-SAC-2018-01
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:
Heart failure
Severe systolic disfunction
Sacubitril-Valsartan
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Valsartan
LCZ 696
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action