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Completed

NCT Number: NCT04735354

Sacubitril/Valsartan in Heart Failure With Reduced Ejection Fraction Patients: a Real World Study in India

This was a non-interventional, retrospective EMR analysis of longitudinal prescriptions in India for a period of 1.5 years. Demographic profile of patients with heart failure with reduced ejection fraction on sacubitril/valsartan was recorded.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigational Site

Mumbai, India

About this study

Index date was date of 1st prescription of sacubitril/valsartan. Dose titration of sacubitril/valsartan was assessed for a period of 6 months post index date.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients ≥18 years with a diagnosis of HFrEF as mentioned in database or heart failure with a recording of LVEF <40% at or before the index date
  • A prescription of sacubitril/valsartan

Exclusion criteria

  • Diagnosis of HF specified as preserved/mid-range ejection fraction

Treatment and study plan

sacubitril/valsartan

Drug

There was no treatment allocation. Patients administered sacubitril/valsartan by prescription that started before inclusion of the patient into the study were enrolled.

Primary outcomes

  1. Age information

    Time frame: Index date

    Age information was reported

  2. Gender information

    Time frame: Index date

    Gender information was reported

  3. Number of participants by Geographic area

    Time frame: idex date

    Geographic area divided into 4 zones- North, South, East and West

  4. Functional Class (New York Heart Association (NYHA) classification)

    Time frame: index date

    The New York Heart Association Functional Classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina.

  5. Body Mass Index

    Time frame: Index date

    Median value body mass index was reported

  6. Classification of Heart Failure by etiology

    Time frame: 1.5 years

    Coronary artery disease, valvular, rheumatic heart disease, others, unknown.

  7. Change in ventricular function defined by Left Ventricular Ejection Fraction (LVEF)

    Time frame: Index date, 1.5 years

    An ejection fraction (EF) is the volumetric fraction (or portion of the total) of fluid ejected from a chamber with each contraction (or heartbeat).

  8. Medical History

    Time frame: 1.5 years

    type 2 diabetes, chronic obstructive pulmonary disease (COPD), anemia, chronic renal disease, atrial fibrillation, stroke, hypertension, myocardial infarction

  9. Number of participants with notable changes in laboratory parameters

    Time frame: Baseline, 1.5 years

    Safety measured by the notable post-baseline changes in laboratory parameters compared to baseline

  10. Number of Hospitalizations

    Time frame: 1.5 years

    Hospitalizations due to cardiovascular and non-cardiovascular causes

  11. Number of participants with concomitant medications

    Time frame: up to 6 months pre index date, Up to 6 months post index date

    Concomitant medications classified as-

    • Medications for HF: Diuretics, digitalis, beta-Blockers, ACEi, ARBs, MRA, ivabradine, SGLT2 inhibitors.
    • Medications for non-HF conditions: Anti-diabetic medications other than SGLT2 inhibitors (oral and injectable), statin, antiplatelet therapy, oral anti-coagulants.

  12. Number of patients with other treatments for heart failure

    Time frame: 1.5 years

    Other treatments for heart failure like implantable cardioverter-defibrillator (ICD), and cardiac resynchronization therapy (CRT).

Secondary outcomes

  1. Persistence to sacubitril/valsartan

    Time frame: Up to 12 months post index date

    Defined as time duration from initiation to discontinuation of therapy.

  2. Proportion of patient discontinuing sacubitril/valsartan

    Time frame: month 2, month 4, month 6, month 8 and month 12

    Reported as frequency (n) and percentage (%).

  3. Maximum individual dose reached

    Time frame: 6 months post index date

    Median value of maximum individual dose reached will be reported

  4. Time to first dose up-titration

    Time frame: 6 months post index date

    Median time to first dose up-titration

  5. Time to target dose

    Time frame: 6 months post index date

    Median time to target dose

  6. Individual dose

    Time frame: 6 months post index date

    The proportion of patients with a starting dose of 50 mg, 100 mg, 200 mg

  7. Titration patterns

    Time frame: 1.5 years

    Listings for all titration patterns which evaluated longitudinally at the patient level as follows:

    • Up-titration' corresponds to all patients who experience an initial increase in sacubitril/valsartan dose post-index,
    • 'Stable up-titration' corresponds to up-titrated patients who experience no subsequent decrease in sacubitril/valsartan dose
    • 'Down-titration' corresponds to all patients who experience an initial dose decrease in sacubitril/valsartan dose post-index, and
    • 'Stable down-titration' corresponds to the proportion of down-titrated patients who experience no subsequent up-titration.

  8. Proportion of patients being titrated to 100mg from 50mg

    Time frame: 1.5 years

    Proportion of patients being titrated to 100mg from 50mg

  9. Proportion of patients being titrated to 200mg from 100mg

    Time frame: 1.5 years

    Proportion of patients being titrated to 200mg from 100mg

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 3, 2021
Registry last updated
May 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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