Controlling blood pressure in patients with asymptomatic aortic valve stenosis

Blood Pressure Reduction in Patients With Asymptomatic Aortic VALVE Stenosis

This study is testing if keeping blood pressure under strict control can help people with moderate to severe aortic valve stenosis avoid heart problems and delay the need for valve replacement.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Aarhus University Hospital (other)
• Locations: 6 sites (Aarhus and 5 other locations)
• Trial ID: NCT04613193 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of strict blood pressure control compared to conventional care in patients with asymptomatic moderate to severe aortic valve stenosis. It is a randomized, open-label, controlled intervention trial designed to assess whether strict blood pressure management can reduce the progression of left ventricular remodeling and aortic valve calcification over time. The study will evaluate outcomes over a period of up to 10 years, focusing on the need for aortic valve replacement and cardiovascular events. Participants will be monitored for changes in their condition and overall heart health.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with asymptomatic moderate to severe aortic valve stenosis and elevated blood pressure.

Not a fit: Patients with symptomatic aortic stenosis or significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve heart health and reduce the need for surgical interventions in patients with aortic valve stenosis.

How similar studies have performed: Other studies have shown promising results with strict blood pressure management in similar patient populations, suggesting potential for success in this approach.

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

Where this trial is running

Aarhus and 5 other locations

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

Study contacts

• Principal investigator: Henrik Wiggers — Aarhus University Hospital, Department of Cardiology
• Study coordinator: Henrik Wiggers, MD, PhD

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