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Active, Not Recruiting

NCT Number: NCT06604897

Effectiveness of Entresto (Sacubitril/Valsartan) in Japanese Patients With Hypertension

This study is a non-interventional, secondary use of data, retrospective, cohort study, and the data to be extracted in this study will be used as secondary use of collected patient information in the database (Japan Medical Data Survey [JAMDAS]) owned by M3 Inc. JAMDAS is a database that aggregates medical information and is constructed mainly from electronic medical record information of general practices, allowing real-time extraction of information entered in medical records, such as prescription status including drug switching and continuation, laboratory values, clinical evaluation scores, and comorbidities, etc.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

East Hanover, New Jersey, 07936, United States

Who can participate

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

Inclusion criteria

  • Diagnosed with essential hypertension (International Classification of Diseases [ICD]-10 code: I10) on the index date.
  • Patients for whom data for the 6 months prior to the index date can be extracted as baseline data.
  • Patients for whom blood pressure (BP) data can be extracted between weeks 8 and 12 after the index date.
  • Patients whose BP data can be extracted on the index date.
  • Patients whose BP value at baseline was 140/90 millimeters of mercury (mmHg) or higher.
  • Patients with the prescription of 100 milligrams (mg) or 200 mg once daily as 100 mg or 200 mg tablets on the index date.

Exclusion criteria

  • Women with a record of pregnancy-related diagnoses, drugs, or medical procedures before or after the index date, or a record of delivery- or abortion-related diagnoses, drugs, or medical procedures after the index date.
  • Prescription of concomitant angiotensin-converting enzyme inhibitor (ACEi); Anatomical Therapeutic Chemical (ATC) code: C09A on, after, or in the 2 days before the index date.
  • Patients diagnosed with angioedema: ICD-10: D84.1 under prescription of ACEi or angiotensin receptor blocker (ARB); ATC code: C09C.
  • Patients diagnosed with diabetes and under treatment with aliskiren fumarate on the index date.
  • Patients with severe impaired liver functions with Child-Pugh classification C.

Treatment and study plan

Primary outcomes

  1. Percentage of Patients Achieving the Guideline-recommended Blood Pressure (BP)

    Time frame: Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12)

    The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019) will be used to establish systolic and diastolic blood pressure goals.

Secondary outcomes

  1. Percentage of Patients Achieving the Guideline-recommended Blood Pressure (BP) per BP Category

    Time frame: Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12)

    The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019) will be used to establish systolic and diastolic blood pressure goals.

    BP categories:

    • Grade I: 140-159/90-99 millimeters of mercury (mmHg)
    • Grade II: 160-179/100-109 mmHg
    • Grade III: 180/110 mmHg or greater

  2. Percentage of Patients Achieving the Guideline-recommended BP Categorized by Number of Antihypertensive Medicines Taken Before Starting Sacubitril/Valsartan

    Time frame: Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12)

    The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019) will be used to establish systolic and diastolic blood pressure goals.

    Number of antihypertensive medicines taken before starting sacubitril/valsartan categories: 0, 1, 2, 3-4, and 5 or more.

  3. Percentage of Patients Achieving the Guideline-recommended BP Categorized by Antihypertensive Drug Classes Prescribed With Sacubitril/Valsartan

    Time frame: Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12)

    The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019) will be used to establish systolic and diastolic blood pressure goals.

    Antihypertensive drug classes include:

    • Calcium channel blockers (CCB)
    • Angiotensin-converting enzyme (ACE) inhibitors
    • Angiotensin receptor blockers (ARBs)
    • Diuretics
    • Alpha and beta blockers
    • Alpha-beta blockers
    • Aldosterone blockers
    • Renin inhibitors
    • Compounding agents

  4. Percentage of Patients Achieving the Guideline-recommended BP Categorized by Patient Characteristics

    Time frame: Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12)

    The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019) will be used to establish systolic and diastolic blood pressure goals.

    Patient characteristics include, but are not limited to, age, gender, body mass index (BMI), comorbidities, and combinations of comorbidities.

  5. Number of Patients Categorized by Place of Residence

    Time frame: Baseline

  6. Height

    Time frame: Baseline

  7. Weight

    Time frame: Baseline

  8. Number of Patients Categorized by Comorbidities

    Time frame: Baseline

    Comorbidities include:

    • Heart disease
    • Diabetes
    • Dyslipidemia
    • Renal disease
    • Cerebrovascular disease
    • Other, specify

  9. Relative Contribution of Baseline Characteristics in Achieving the Guideline-recommended BP

    Time frame: Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12)

    The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019) will be used to establish systolic and diastolic blood pressure goals.

    Multivariate logistic regression analysis will be used to determine the association of the following variables in achieving the guideline-recommended BP.

    • Age
    • Gender
    • Comorbidities
    • Body mass index (BMI)
    • BP category at index date
    • Number of classes of antihypertensive medicines taken before starting sacubitril/valsartan

  10. Persistence on Sacubitril/Valsartan

    Time frame: Up to 16 weeks

    Proportion of patients remaining on treatment with sacubitril/valsartan and proportion of patients permanently discontinuing sacubitril/valsartan during the study.

  11. Number of Episodes of Hypotension-related Events

    Time frame: Up to 16 weeks

    Hypotension-related events include:

    • Orthostatic hypotension
    • Postural hypotension
    • Secondary orthostatic hypotension
    • Hypertension due to the drugs
    • Episodic hypotension
    • Hypotension
    • Vertigo
    • Feeling dizzy
    • Dizziness
    • Sudden dizziness
    • Syncope

  12. Number of Episodes of Renal Events

    Time frame: Up to 16 weeks

    Renal events include:

    • Renal diseases
    • Chronic kidney disease (CKD)
    • Estimated glomerular filtration rate (eGFR) reduction of 40% or more

  13. Number of Episodes of Dehydration-related Events

    Time frame: Up to 16 weeks

    Dehydration-related events include:

    • Dehydration
    • Isotonic dehydration

  14. Number of Episodes of Diuresis-related Events

    Time frame: Up to 16 weeks

    Diuresis-related events include:

    • Polyuria
    • Idiopathic polyuria
    • Frequent urination
    • Nocturnal polyuria
    • Nocturia

  15. Number of Episodes of Edema or Angioedema-related Events

    Time frame: Up to 16 weeks

    Edema or angioedema-related events include:

    • Angioneurotic edema
    • Quincke's edema

  16. Percentage of Patients Treated With Sacubitril/Valsartan Achieving the Guideline-recommended BP Compared to the Percentage of Patients Treated With Angiotensin-converting Enzyme Inhibitor/Angiotensin Receptor Blocker (ACEi/ARB)

    Time frame: Up to approximately 12 weeks (the BP measurement timepoint closest to 8 weeks between weeks 8 and 12)

    The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019) will be used to establish systolic and diastolic blood pressure goals.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

Effectiveness of Entresto (Sacubitril/Valsartan) to Blood Pressure Control in Japanese Patients With Hypertension: the Database Analysis of Electronic Medical Records

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 20, 2024
Registry last updated
Sep 20, 2024

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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