Blood Pressure Reduction in Patients With Asymptomatic Aortic VALVE Stenosis

Overview

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.

Interventions

• Other Blood presssure reduction
  Patients will be uptitrated in antihypertensive treatment until the treatment target is achieved.

Primary outcome measures

• Change in LV mass [Time frame: Changes will be evaluated after an expected average of 12 months treatment]
• 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]
• Clinical composite endpoint: [Time frame: Will be evaluated after an expected average of 7-13 years of treatment]

Secondary outcome measures (11)

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Denmark · 6 centers

• Dept. of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99 — Aarhus
• Dept. of Cardiology, Herning Hospital — Herning
• Dept. of cardiology, Horsens Hospital — Horsens
• Dept. of cardiology, Randers Hospital — Randers
• Silkeborg Hospital — Silkeborg
• Dept. of cardiology, Viborg Hospital — Viborg

Identifiers

NCT: NCT04613193 · BP-AVALVE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗