Effectiveness of Entresto (Sacubitril/Valsartan) in Japanese Patients With Hypertension
- Conditions
- Registration Number
- NCT06604897
- Lead Sponsor
- Novartis
- Brief Summary
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 electr...
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1405
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Patients Achieving the Guideline-recommended Blood Pressure (BP) 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 Outcome Measures
Name Time Method Percentage of Patients Achieving the Guideline-recommended Blood Pressure (BP) per BP Category 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 greaterPercentage of Patients Achieving the Guideline-recommended BP Categorized by Number of Antihypertensive Medicines Taken Before Starting Sacubitril/Valsartan 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.Percentage of Patients Achieving the Guideline-recommended BP Categorized by Antihypertensive Drug Classes Prescribed With Sacubitril/Valsartan 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
...Percentage of Patients Achieving the Guideline-recommended BP Categorized by Patient Characteristics 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.Number of Patients Categorized by Place of Residence Baseline Height Baseline Weight Baseline Number of Patients Categorized by Comorbidities Baseline Comorbidities include:
* Heart disease
* Diabetes
* Dyslipidemia
* Renal disease
* Cerebrovascular disease
* Other, specifyRelative Contribution of Baseline Characteristics in Achieving the Guideline-recommended BP 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
...Persistence on Sacubitril/Valsartan Up to 16 weeks Proportion of patients remaining on treatment with sacubitril/valsartan and proportion of patients permanently discontinuing sacubitril/valsartan during the study.
Number of Episodes of Hypotension-related Events 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
* SyncopeNumber of Episodes of Renal Events Up to 16 weeks Renal events include:
* Renal diseases
* Chronic kidney disease (CKD)
* Estimated glomerular filtration rate (eGFR) reduction of 40% or moreNumber of Episodes of Dehydration-related Events Up to 16 weeks Dehydration-related events include:
* Dehydration
* Isotonic dehydrationNumber of Episodes of Diuresis-related Events Up to 16 weeks Diuresis-related events include:
* Polyuria
* Idiopathic polyuria
* Frequent urination
* Nocturnal polyuria
* NocturiaNumber of Episodes of Edema or Angioedema-related Events Up to 16 weeks Edema or angioedema-related events include:
* Angioneurotic edema
* Quincke's edemaPercentage 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) 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.
Trial Locations
- Locations (1)
Novartis
🇺🇸East Hanover, New Jersey, United States