NCT04613193 Blood Pressure Reduction in Patients With Asymptomatic Aortic VALVE Stenosis
| NCT ID | NCT04613193 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Henrik Wiggers |
| Condition | Aortic Valve Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2019-03-01 |
| Primary Completion | 2031-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2019-03-01 with a primary completion date of 2031-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Henrik Wiggers, MD, PhD
✉ henrikwiggers@dadlnet.dkHenrik Wiggers
PRINCIPAL INVESTIGATOR
Aarhus University Hospital, Department of Cardiology
Frequently Asked Questions
Who can join the NCT04613193 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Valve Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04613193 currently recruiting?
Yes, NCT04613193 is actively recruiting participants. Contact the research team at henrikwiggers@dadlnet.dk for enrollment information.
Where is the NCT04613193 trial being conducted?
This trial is being conducted at Aarhus, Denmark, Herning, Denmark, Horsens, Denmark, Randers, Denmark and 2 additional locations.
Who is sponsoring the NCT04613193 clinical trial?
NCT04613193 is sponsored by Henrik Wiggers. The principal investigator is Henrik Wiggers at Aarhus University Hospital, Department of Cardiology. The trial plans to enroll 200 participants.