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NCT04613193Completed

Blood Pressure Reduction in Patients With Asymptomatic Aortic VALVE Stenosis

Source: ClinicalTrials.gov · Last updated 1 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
60 (actual)
First submitted
9 Jul 2020
Start date
1 Mar 2019
Primary completion date
1 May 2025
Lead sponsor
Henrik Wiggers
NCT number
NCT04613193

What you commit to

  • Study type: Interventional
  • Participants enrolled: 60
  • From 1 Mar 2019 to the primary completion date, 1 May 2025
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participation in other randomized drug study (device studies accepted)
  • 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.

Other illness

  • Suspicion of secondary hypertension
  • Significant coronary obstructive lesions detected by baseline Cardiac CT that requires a revascularisation procedure.
  • Other disease, comorbidity or treatment making the subject unsuitable for study participation as judged by the investigator

Lab values

  • eGFR \< 30 ml/min or end-stage renal disease

Other

  • Symptoms due to AS
  • Symptomatic orthostatic hypotension and/or one minute standing SBP \< 110 mmHg (16).
  • Moderat to severe aortic valve regurgitation e.g. vena contracta \> 5 mm, assessed by echocardiography)

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Dept. of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99
Coordinator of this site? Confirm its status
AarhusDenmarkUnknown status
Dept. of Cardiology, Herning Hospital
Coordinator of this site? Confirm its status
HerningDenmarkUnknown status
Dept. of cardiology, Horsens Hospital
Coordinator of this site? Confirm its status
HorsensDenmarkUnknown status
Dept. of cardiology, Randers Hospital
Coordinator of this site? Confirm its status
RandersDenmarkUnknown status
Silkeborg Hospital
Coordinator of this site? Confirm its status
SilkeborgDenmarkUnknown status
Dept. of cardiology, Viborg Hospital
Coordinator of this site? Confirm its status
ViborgDenmarkUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.