Blood Pressure Reduction in Patients With Asymptomatic Aortic VALVE Stenosis

Henrik Wiggers6 sites in 1 country200 target enrollmentMarch 1, 2019

ConditionsAortic Valve Stenosis Hypertension,Essential Heart Failure

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aortic Valve Stenosis
Sponsor: Henrik Wiggers
Enrollment: 200
Locations: 6
Primary Endpoint: Change in LV mass
Status: Recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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:

Strict BP control for 12 months reduces the progression of LV remodelling compared to conventional treatment.
Strict BP control for 2 years reduces the increase in aortic valve calcification and LV remodelling compared to conventional treatment.
Strict BP reduction for up to 10 years reduces the need for aortic valve replacement and cardiovascular events compared to conventional care.

Registry

clinicaltrials.gov

Start Date

March 1, 2019

End Date

June 1, 2031

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Henrik Wiggers

Responsible Party

Sponsor Investigator

Principal Investigator

Henrik Wiggers

Consultant, Associate professor, MD, PhD, DMSc

Aarhus University Hospital

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•Symptoms due to AS
•Symptomatic orthostatic hypotension and/or one minute standing SBP \< 110 mmHg (16).
•Suspicion of secondary hypertension
•Participation in other randomized drug study (device studies accepted)
•Moderat to severe aortic valve regurgitation e.g. vena contracta \> 5 mm, assessed by echocardiography)
•Known or suspected ischemic heart disease (coronary angiography with \>70% stenosis in a major epicardial vessel, symptoms or signs of myocardial ischemia, e.g. angina pectoris, wall motion abnormalities). Patients who have previously undergone complete revascularization of major coronary arteries due to angina pectoris are eligible for inclusion.
•Significant coronary obstructive lesions detected by baseline Cardiac CT that requires a revascularisation procedure.
•eGFR \< 30 ml/min or end-stage renal disease
•Other disease, comorbidity or treatment making the subject unsuitable for study participation as judged by the investigator

Outcomes

Primary Outcomes

Change in LV mass

Time Frame: Changes will be evaluated after an expected average of 12 months treatment

LV mass as measured by cardiac MR

Clinical composite endpoint:

Time Frame: Will be evaluated after an expected average of 7-13 years of treatment

Major cardiovascular events including death from cardiovascular causes, aortic valve replacement, non-fatal myocardial infarction, hospitalization for unstable angina pectoris, heart failure, coronary artery bypass surgery, percutaneous coronary intervention, and haemorrhagic and non-haemorrhagic stroke, new onset atrial fibrillation.

Change in aortic valve CT calcium volume and aortic peak gradient

Time Frame: Changes will be evaluated after an expected average of 2-3 years treatment

Cardiac CT and Echocardiography

Secondary Outcomes

LV myocardial fibrosis(Through study completion, an average of 1 year)
Aortic peak and mean gradients(Through study completion, an average of 1 year)
Myocardial perfusion during rest and stress(Through study completion, an average of 1 year)
Valvolu-arterial impedance(Through study completion, an average of 1 year)
Ambulatory 24-hour blood pressure measurement(Through study completion, an average of 1 year)
LV mass-cavity ratio.(Through study completion, an average of 1 year)
Left ventricular global longitudinal strain(Through study completion, an average of 1 year)
Minnesota living with heart failure questionnaire(Through study completion, an average of 1 year)
Dimensions and aortic calcium score of the thoracic aorta.(Through study completion, an average of 2 years)
Aortic valve area(Through study completion, an average of 1 year)
NT-proBNP(Baseline and follow-up)