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Blood Pressure Reduction in Patients With Asymptomatic Aortic VALVE Stenosis

NCT04613193 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-11-03

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Blood presssure reduction

Patients will be uptitrated in antihypertensive treatment until the treatment target is achieved.

Sponsors & Collaborators

  • Danish Heart Foundation

    collaborator OTHER

  • Henrik Wiggers

    lead OTHER

Principal Investigators

  • Henrik Wiggers · Aarhus University Hospital, Department of Cardiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2031-01-01
Completion
2031-06-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04613193 on ClinicalTrials.gov