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Sacubitril/Valsartan Versus Valsartan in Heart Failure With Improved Ejection Fraction

NCT04803175 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2021-08-18

No results posted yet for this study

Summary

Heart failure (HF) is a chronic disease with weakened heart muscles or abnormal pressure within the heart chambers result in breathlessness, leg edema, or fatigue. A subclass of HF shows reduced heart muscle contractility, which is represented by the left ventricular ejection fraction (LVEF). Valsartan is an angiotensin II receptor blocker, a major drug class for heart failure. Sacubitril/valsartan is a combination of 2 drugs, classified as a new class of drug called angiotensin receptor neprilysin inhibitor (ARNI). Although these medications are both first-line treatment in HF with reduced LVEF, recent guidelines encourage the use of sacubitril/valsartan in patients with ongoing symptoms. After successful treatment, some patients experience recovery of LVEF. In these patients, otherwise called heart failure with improved ejection fraction (HFiEF), it is not clear whether continued treatment with sacubitril/valsartan or valsartan is beneficial in terms of relapse of heart failure or worsening of LVEF. Therefore, the investigators aim to determine whether the treatment with sacubitril/valsartan versus valsartan differs in clinical outcomes after 1 year in HFiEF patients by observing the change in blood test markers of heart failure (N-terminal prohormone of brain natriuretic peptide; NT-proBNP) and aggravation of HF defined as reduced LVEF, congestive symptoms, hospitalization or death from HF.

Conditions

  • Heart Failure, Systolic

Interventions

DRUG

Sacubitril-Valsartan

Participants will receive individualized dosage and titration as part of routine medical care, and a the effect will be studied for at least 12 months. The investigator does not assign specific interventions to the study participants.

DRUG

Valsartan

Participants will receive individualized dosage and titration as part of routine medical care, and a the effect will be studied for at least 12 months. The investigator does not assign specific interventions to the study participants.

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-16
Primary Completion
2024-02-29
Completion
2025-02-28

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04803175 on ClinicalTrials.gov