Blood Pressure Reduction in Patients With Asymptomatic Aortic VALVE Stenosis

Not Applicable

Recruiting

• Conditions: Aortic Valve Stenosis; Hypertension,Essential; Heart Failure
• Interventions: Other: Blood presssure reduction

• Registration Number: NCT04613193
• Lead Sponsor: Henrik Wiggers

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:

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2020-07-09
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-27
• Last Update Submitted: 2020-10-27
• Study First Posted: 2020-11-03
• Last Update Posted: 2020-11-03
• Primary Completion: 2031-01-01
• Study Completion: 2031-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Strict BP intervention group	Blood presssure reduction	SBP \< 120 mmHg and a reduction in SBP of \>= 15 mmHg
Conventional BP control group	Blood presssure reduction	In patients \< 75 years: SBP = 135 mmHg In patients \>/= 75 years: SBP = 145 mmHg

Primary Outcome Measures

Name	Time	Method
Change in LV mass	Changes will be evaluated after an expected average of 12 months treatment	LV mass as measured by cardiac MR
Clinical composite endpoint:	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	Changes will be evaluated after an expected average of 2-3 years treatment	Cardiac CT and Echocardiography

Secondary Outcome Measures

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

Trial Locations

Locations (6)

Dept. of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99; 🇩🇰 Aarhus, Denmark

Dept. of Cardiology, Herning Hospital; 🇩🇰 Herning, Denmark

Dept. of cardiology, Horsens Hospital; 🇩🇰 Horsens, Denmark

Dept. of cardiology, Randers Hospital; 🇩🇰 Randers, Denmark

Silkeborg Hospital; 🇩🇰 Silkeborg, Denmark

Dept. of cardiology, Viborg Hospital; 🇩🇰 Viborg, Denmark