Blood Pressure Reduction in Patients With Asymptomatic Aortic VALVE Stenosis (BP-AVALVE)

Henrik Wiggers

Status: Enrolling

Conditions: Hypertension,Essential; Aortic Valve Stenosis; Heart Failure

Treatments: Other: Blood presssure reduction

Study type: Interventional

Funder types: Other

Identifiers

NCT04613193

BP-AVALVE

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Strict BP intervention group

Active Comparator group

Description:

SBP \< 120 mmHg and a reduction in SBP of \>= 15 mmHg

Treatment:

Other: Blood presssure reduction

Conventional BP control group

Other group

Description:

In patients \< 75 years: SBP = 135 mmHg In patients \>/= 75 years: SBP = 145 mmHg

Treatment:

Other: Blood presssure reduction