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NCT Number: NCT04613193

Blood Pressure Reduction in Patients With Asymptomatic Aortic VALVE Stenosis

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood presssure reduction

Other

Patients will be uptitrated in antihypertensive treatment until the treatment target is achieved.

Primary outcomes

  1. Change in LV mass

    Time frame: Changes will be evaluated after an expected average of 12 months treatment

    LV mass as measured by cardiac MR

  2. Change in aortic valve CT calcium volume and aortic peak gradient

    Time frame: Changes will be evaluated after an expected average of 2-3 years treatment

    Cardiac CT and Echocardiography

  3. Clinical composite endpoint:

    Time frame: Will be evaluated after an expected average of 7-13 years of treatment

    Major cardiovascular events including death from cardiovascular causes, aortic valve replacement, non-fatal myocardial infarction, hospitalization for unstable angina pectoris, heart failure, coronary artery bypass surgery, percutaneous coronary intervention, and haemorrhagic and non-haemorrhagic stroke, new onset atrial fibrillation.

Secondary outcomes

  1. LV mass-cavity ratio.

    Time frame: Through study completion, an average of 1 year

    Cardiac MR

  2. LV myocardial fibrosis

    Time frame: Through study completion, an average of 1 year

    Cardiac MR

  3. Myocardial perfusion during rest and stress

    Time frame: Through study completion, an average of 1 year

    Cardiac MR

  4. Aortic peak and mean gradients

    Time frame: Through study completion, an average of 1 year

    Echocardiography

  5. Aortic valve area

    Time frame: Through study completion, an average of 1 year

    Echocardiography

  6. Left ventricular global longitudinal strain

    Time frame: Through study completion, an average of 1 year

    Echocardiography

  7. Valvolu-arterial impedance

    Time frame: Through study completion, an average of 1 year

    Echocardiography

  8. NT-proBNP

    Time frame: Baseline and follow-up

    Blood test

  9. Minnesota living with heart failure questionnaire

    Time frame: Through study completion, an average of 1 year

    Questionnaire

  10. Ambulatory 24-hour blood pressure measurement

    Time frame: Through study completion, an average of 1 year

    Ambulatory 24-hour blood pressure measurement

  11. Dimensions and aortic calcium score of the thoracic aorta.

    Time frame: Through study completion, an average of 2 years

    cardiac CT

Study contacts

Contact information is provided by the study sponsor or research team.

Henrik Wiggers, MD, PhD

CONTACT

[email protected]

Jonas A Povlsen, MD

CONTACT

[email protected]

+452270282

Sponsors and collaborators

Lead sponsor

Henrik Wiggers

Other

Collaborators

  • Danish Heart Foundation

Registry information

Acronym: BP-AVALVE

Important dates

Study start
2019
Primary completion
2031
Study completion
2031
First posted
Nov 3, 2020
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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