Blood Pressure Reduction in Patients With Asymptomatic Aortic VALVE Stenosis

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The aim of this study is to investigate the effect of strict blood pressure control versus conventional care in patients with asymptomatic moderate to severe aortic valve stenosis. The study is a randomized (1:1), open label, controlled intervention trial. Hypothesis: 1. Strict BP control for 12 months reduces the progression of LV remodelling compared to conventional treatment. 2. Strict BP control for 2 years reduces the increase in aortic valve calcification and LV remodelling compared to conventional treatment. 3. Strict BP reduction for up to 10 years reduces the need for aortic valve replacement and cardiovascular events compared to conventional care.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Aortic valve peak velocity (Vmax) of 3.0-5.0 m/s and/or aortic valve area (AVA) ≤ 1.2 cm2

• Blood pressure: SBP \>= 127 mmHg measured by BP-TRU

• LVEF ≥ 50%

• Age \> 18 years

• Safe birth control management (intrauterine devices or hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release)) for women of childbearing potential.

• Negative urine-HCG for women of childbearing potential

• Ability to understand the written patient information and to give informed consent.

Locations
Other Locations
Denmark
Dept. of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99
RECRUITING
Aarhus
Dept. of Cardiology, Herning Hospital
NOT_YET_RECRUITING
Herning
Dept. of cardiology, Horsens Hospital
NOT_YET_RECRUITING
Horsens
Dept. of cardiology, Randers Hospital
NOT_YET_RECRUITING
Randers
Silkeborg Hospital
NOT_YET_RECRUITING
Silkeborg
Dept. of cardiology, Viborg Hospital
NOT_YET_RECRUITING
Viborg
Contact Information
Primary
Henrik Wiggers, MD, PhD
henrikwiggers@dadlnet.dk
Backup
Jonas A Povlsen, MD
jonapovl@rm.dk
+452270282
Time Frame
Start Date: 2019-03-01
Estimated Completion Date: 2031-06-01
Participants
Target number of participants: 200
Treatments
Active_comparator: Strict BP intervention group
SBP \< 120 mmHg and a reduction in SBP of \>= 15 mmHg
Other: Conventional BP control group
In patients \< 75 years: SBP = 135 mmHg In patients \>/= 75 years: SBP = 145 mmHg
Related Therapeutic Areas
Sponsors
Leads: Henrik Wiggers
Collaborators: Danish Heart Foundation

This content was sourced from clinicaltrials.gov