Blood Pressure Reduction in Patients With Asymptomatic Aortic VALVE Stenosis

Launched by HENRIK WIGGERS · Oct 27, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how strict control of blood pressure can affect patients who have moderate to severe aortic valve stenosis but do not show any symptoms. Aortic valve stenosis is a condition where the heart's aortic valve becomes narrow, making it harder for the heart to pump blood. The researchers want to see if keeping blood pressure under tight control can slow down changes in the heart and the aortic valve over time compared to standard care. They will look at how this blood pressure management impacts the need for surgery or other heart-related problems over a period of up to 10 years.

To participate in the study, you must be over 18 years old, have specific measurements related to your aortic valve and blood pressure, and have a good heart function. Women who can become pregnant need to use reliable birth control. During the study, participants will receive regular check-ups and guidance on managing their blood pressure. It’s important to note that if you have symptoms related to aortic valve stenosis or other serious heart conditions, you may not be eligible to join. Overall, this trial aims to find better ways to manage heart health in patients with this specific condition.

Gender

ALL

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