Hypertension Clinical Trial
Official title:
Randomized Preventive Vascular Screening Trial of 65-74 Year Old Men in the Central Region of Denmark
Well-documented health benefits may be achieved through prophylactic screening for
cardiovascular disease. The advantages are fewer premature deaths and a reduction in the
number of hospital admissions and amputations. Furthermore, hospitals will benefit from the
derived reduction in the pressure on surgery and intensive care capacities at vascular
surgery departments.
It therefore seems extremely relevant to offer joint screening for abdominal aortic
aneurysm, peripheral arterial disease and hypertension, even if the benefit and costs of
such a measure are not currently known.
Consequently, the primary objective of the study is to establish the effect and
cost-efficiency of a joint circulation screening programme for 40,000 men aged 65-74 years
in a randomised, clinically controlled study.
The project manager will train six nurses to measure ABI and perform ultrasound scans of the
aorta. The nurses form three teams which will each be equipped with a portable Doppler,
blood pressure cuff and portable ultrasound scanner. Each team will operate from the
hospitals in the Region. Civil registration number (in Danish: CPR), name and address
information will be supplied by the Clinical Epidemiological Department (CED), which will
also perform the randomisation in groups of approx. 1,000 to avoid too long a period from
data extraction to invitation. Half of the randomised subjects will be invited to
participate in a circulation examination focused on PAD, AAA and hypertension, while the
other half will be controls Men with positive findings are informed and proper preventive
actions is taken. Annual controls are offered, and AAA exceeding 5.5 cm in diameter is
offered operation.
The primary efficiency variables are death, cardiovascular death and AAA-death. The
secondary efficiency variables are hospital services related to cardiovascular conditions
and costs for such services in accordance with current DRG rates.
The entire population, the controls as well as the screening group, will be monitored for a
period of 10 years. Information concerning deaths, including date of death, is obtained from
the Civil Registration System, information on visits to outpatient clinics and hospital
admissions caused by cardiovascular conditions including amputations is obtained from the
National Patient Registry. From the Danish Causes of Death Registry information on cause of
death is collected. The information is classified with regards to cause; AAA or
cardiovascular. The cardiovascular interventions are identified in the vascular surgery
database (Karbasen). Major follow-up is performed at 3, 5 and 10 years.
A steering and data validation group will be formed including the project manager and a
representative from the Clinical Epidemiology Department. Furthermore, a vascular surgeon
from each of the two affected departments in the region will participate.
Total mortality, cardiovascular and AAA-related mortality and initial cardiovascular
hospital service are compared for the two groups using Cox proportional hazards-regression
analysis which facilitates description of the risk ratio. The cost-efficiency calculation
will be adjusted for quality of life.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Screening
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04591808 -
Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia
|
Phase 3 | |
Recruiting |
NCT04515303 -
Digital Intervention Participation in DASH
|
||
Completed |
NCT05433233 -
Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension
|
N/A | |
Completed |
NCT05491642 -
A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses
|
Phase 1 | |
Completed |
NCT03093532 -
A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Completed |
NCT05529147 -
The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
|
||
Recruiting |
NCT06363097 -
Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
|
||
Recruiting |
NCT05976230 -
Special Drug Use Surveillance of Entresto Tablets (Hypertension)
|
||
Completed |
NCT06008015 -
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT05387174 -
Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period
|
N/A | |
Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
Recruiting |
NCT05121337 -
Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension
|
N/A | |
Withdrawn |
NCT04922424 -
Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men
|
Phase 1 | |
Active, not recruiting |
NCT05062161 -
Sleep Duration and Blood Pressure During Sleep
|
N/A | |
Completed |
NCT05087290 -
LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
|
||
Not yet recruiting |
NCT05038774 -
Educational Intervention for Hypertension Management
|
N/A | |
Completed |
NCT05621694 -
Exploring Oxytocin Response to Meditative Movement
|
N/A | |
Completed |
NCT05688917 -
Green Coffee Effect on Metabolic Syndrome
|
N/A | |
Recruiting |
NCT05575453 -
OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure
|
N/A |