Blood Pressure Reduction in Patients With Asymptomatic Aortic VALVE Stenosis

Last updated: October 27, 2020
Sponsor: Henrik Wiggers
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hyponatremia

High Blood Pressure (Hypertension - Pediatric)

Chest Pain

Treatment

N/A

Clinical Study ID

NCT04613193
BP-AVALVE
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Aortic valve peak velocity (Vmax) of 3.0-5.0 m/s and/or aortic valve area (AVA) ≤ 1.2cm2
  • 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 orinjections 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

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 byechocardiography)
  • Known or suspected ischemic heart disease (coronary angiography with >70% stenosis ina major epicardial vessel, symptoms or signs of myocardial ischemia, e.g. anginapectoris, wall motion abnormalities). Patients who have previously undergone completerevascularization of major coronary arteries due to angina pectoris are eligible forinclusion.
  • Significant coronary obstructive lesions detected by baseline Cardiac CT that requiresa revascularisation procedure.
  • eGFR < 30 ml/min or end-stage renal disease
  • Other disease, comorbidity or treatment making the subject unsuitable for studyparticipation as judged by the investigator

Study Design

Total Participants: 200
Study Start date:
March 01, 2019
Estimated Completion Date:
June 01, 2031

Connect with a study center

  • Dept. of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99

    Aarhus,
    Denmark

    Active - Recruiting

  • Dept. of Cardiology, Herning Hospital

    Herning,
    Denmark

    Site Not Available

  • Dept. of cardiology, Horsens Hospital

    Horsens,
    Denmark

    Site Not Available

  • Dept. of cardiology, Randers Hospital

    Randers,
    Denmark

    Site Not Available

  • Silkeborg Hospital

    Silkeborg,
    Denmark

    Site Not Available

  • Dept. of cardiology, Viborg Hospital

    Viborg,
    Denmark

    Site Not Available

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