Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-01-15 @ 2:50 PM
Study NCT ID:
NCT03046420
Status:
COMPLETED
Last Update Posted:
2021-05-20
First Post:
2017-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypertension in Long-Term Care Facilities
Sponsor:
Louisiana State University Health Sciences Center in New Orleans
Organization:
Study Overview
Official Title:
Hypertension Prevalence, Treatment Patterns and Outcomes in Long-Term Care Facilities
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is exploratory in nature and seeks to describe hypertension diagnosis and management among patients in long-term care (LTC) facilities.
Specifically, the primary objective is to:
• Identify LTC patients who are diagnosed with hypertension and assess the management and different outcomes of proper control of BP regarding to incidence of falls, cognitive decline, kidney diseases, cardiovascular diseases and incidence of cerebrovascular accidents
The secondary objectives are to:
Describe treatment patterns of hypertension in LTC facilities
* Identify patients who are receiving non-pharmacological treatment and effectiveness of this modality of treatment.
* Identify different classes of drugs used to treat hypertension in patients staying at LTC facility
* Identify different drug adverse effects encountered by patients receiving medical treatment.
* Identify patients who achieved normal blood pressure according to current guidelines
Specifically, the primary objective is to:
• Identify LTC patients who are diagnosed with hypertension and assess the management and different outcomes of proper control of BP regarding to incidence of falls, cognitive decline, kidney diseases, cardiovascular diseases and incidence of cerebrovascular accidents
The secondary objectives are to:
Describe treatment patterns of hypertension in LTC facilities
* Identify patients who are receiving non-pharmacological treatment and effectiveness of this modality of treatment.
* Identify different classes of drugs used to treat hypertension in patients staying at LTC facility
* Identify different drug adverse effects encountered by patients receiving medical treatment.
* Identify patients who achieved normal blood pressure according to current guidelines
Detailed Description:
Isolated systolic hypertension is more common in elderly than younger adults. Also blood pressure (BP) in elderly tends to be very high, difficult to treat. Many studies are done to understand the mechanism of hypertension in older adults, most of them concluded that the main mechanisms are chronic inflammation, oxidative stress and endothelial dysfunction. Hypertension is often called a "silent killer" and it is a major high risk factor of heart, chronic kidney and cerebrovascular diseases . Systolic BP (SBP) gradually increases from early adulthood to old age, whilst diastolic BP (DBP) increases until around 50 years of age then reaches a plateau before decreasing again , causing widening of pulse pressure, and elevated blood pressure known as Isolated Systolic Hypertension (ISH).
There is a general consensus across international guidelines for a recommended target BP of SBP ≤ 140 mmHg and DBP≤90 mmHg for the general adult population without diabetes mellitus (DM) however the treatment of hypertension in the elderly requires further clarification and further studies as many international guidelines are inconsistent in providing recommendation on optimal BP for both initiation ant of therapy ad for treatment in the elderly due to the limited outcome date form randomized controlled trials (RCT) in this population .
The American Heart Association recommendations to initiate treatment starting with lifestyle changes and then medication if necessary at 140/90 mmHg until age 80, then at 150/90 mmHg for adults ˃ 80 years old '
The 2014 Joint National Committee's eights report (JNC 8) recommends that in general population aged ≥60 years, to initiate pharmacologic treatment to lower BP at systolic BP (SBP) ≥150 mm Hg or diastolic BP (DBP) ≥90 mm Hg and treat to a goal SBP\<150 mm Hg and goal DBP \<90 mm Hg . However Reisin et al published a commentary on JNC 8 disagreeing with it, having a concern that increasing the SBP level requiring treatment in those ≥60 years old to ≥150/≥90 mmHg may adversely affect renal function.
As Per the European society of Cardiology and the European Society of Hypertension: in elderly patients drug treatment is recommended when systolic BP is ≥160 mmHg, or ≥140 mmHg if younger than 80 years and treatment is well tolerated. It is not recommended to initiate antihypertensive treatment at high normal BP and in younger patients with isolated systolic hypertension.
As per 2011 NICE guidelines the aim for target average blood pressure is \<135/85 mmHg for People \<80 years old and \<145/85mmHg for people ≥80 years .
There is a general consensus across international guidelines for a recommended target BP of SBP ≤ 140 mmHg and DBP≤90 mmHg for the general adult population without diabetes mellitus (DM) however the treatment of hypertension in the elderly requires further clarification and further studies as many international guidelines are inconsistent in providing recommendation on optimal BP for both initiation ant of therapy ad for treatment in the elderly due to the limited outcome date form randomized controlled trials (RCT) in this population .
The American Heart Association recommendations to initiate treatment starting with lifestyle changes and then medication if necessary at 140/90 mmHg until age 80, then at 150/90 mmHg for adults ˃ 80 years old '
The 2014 Joint National Committee's eights report (JNC 8) recommends that in general population aged ≥60 years, to initiate pharmacologic treatment to lower BP at systolic BP (SBP) ≥150 mm Hg or diastolic BP (DBP) ≥90 mm Hg and treat to a goal SBP\<150 mm Hg and goal DBP \<90 mm Hg . However Reisin et al published a commentary on JNC 8 disagreeing with it, having a concern that increasing the SBP level requiring treatment in those ≥60 years old to ≥150/≥90 mmHg may adversely affect renal function.
As Per the European society of Cardiology and the European Society of Hypertension: in elderly patients drug treatment is recommended when systolic BP is ≥160 mmHg, or ≥140 mmHg if younger than 80 years and treatment is well tolerated. It is not recommended to initiate antihypertensive treatment at high normal BP and in younger patients with isolated systolic hypertension.
As per 2011 NICE guidelines the aim for target average blood pressure is \<135/85 mmHg for People \<80 years old and \<145/85mmHg for people ≥80 years .
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: