Aortic Valve StenosisBP-AVALVENCT04613193
Blood Pressure Reduction in Patients With Asymptomatic Aortic VALVE Stenosis
A study testing Blood presssure reduction in people with Aortic Valve Stenosis and Hypertension,Essential, run by Henrik Wiggers at 6 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Hypertension,Essential, Heart Failure
- What is being tested?
- Blood presssure reduction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 6 sitesDenmark
- Study dates
- 1 Mar 2019to 1 Sep 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Denmark6 sites
Dept. of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99
Aarhus
Dept. of Cardiology, Herning Hospital
Herning
Dept. of cardiology, Horsens Hospital
Horsens
Dept. of cardiology, Randers Hospital
Randers
Silkeborg Hospital
Silkeborg
Dept. of cardiology, Viborg Hospital
Viborg
About this study
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:
- Strict BP control for 12 months reduces the progression of LV remodelling compared to conventional treatment.
- Strict BP control for 2 years reduces the increase in aortic valve calcification and LV remodelling compared to conventional treatment.
- Strict BP reduction for up to 10 years reduces the need for aortic valve replacement and cardiovascular events compared to conventional care.
- Conditions
- Aortic Valve Stenosis, Hypertension,Essential, Heart Failure
- Being tested
- Blood presssure reduction
- Keywords
- Aortic Valve Stenosis, Hypertension, Heart failure
- Medical subject headings
- Aortic Valve Stenosis, Essential Hypertension, Heart Failure, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood presssure reductionOther
Patients will be uptitrated in antihypertensive treatment until the treatment target is achieved.
| Study group | Role | What they receive |
|---|---|---|
| Strict BP intervention group | Active comparator | SBP < 120 mmHg and a reduction in SBP of >= 15 mmHg Receives: Other: Blood presssure reduction |
| Conventional BP control group | Other | In patients < 75 years: SBP = 135 mmHg In patients >/= 75 years: SBP = 145 mmHg Receives: Other: Blood presssure reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LV mass
LV mass as measured by cardiac MR
Measured: Changes will be evaluated after an expected average of 12 months treatment
Change in aortic valve CT calcium volume and aortic peak gradient
Cardiac CT and Echocardiography
Measured: Changes will be evaluated after an expected average of 2-3 years treatment
Clinical composite endpoint:
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.
Measured: Will be evaluated after an expected average of 7-13 years of treatment
Secondary outcomes (11)
LV mass-cavity ratio.
Cardiac MR
Measured: Through study completion, an average of 1 year
LV myocardial fibrosis
Cardiac MR
Measured: Through study completion, an average of 1 year
Myocardial perfusion during rest and stress
Cardiac MR
Measured: Through study completion, an average of 1 year
Aortic peak and mean gradients
Echocardiography
Measured: Through study completion, an average of 1 year
Aortic valve area
Echocardiography
Measured: Through study completion, an average of 1 year
Left ventricular global longitudinal strain
Echocardiography
Measured: Through study completion, an average of 1 year
Valvolu-arterial impedance
Echocardiography
Measured: Through study completion, an average of 1 year
NT-proBNP
Blood test
Measured: Baseline and follow-up
Minnesota living with heart failure questionnaire
Questionnaire
Measured: Through study completion, an average of 1 year
Ambulatory 24-hour blood pressure measurement
Ambulatory 24-hour blood pressure measurement
Measured: Through study completion, an average of 1 year
Dimensions and aortic calcium score of the thoracic aorta.
cardiac CT
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start1 Mar 2019
- Primary completion1 May 2025
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1\. BP-AVALVE I: 60 patients will be randomized (1:1) to either strict BP control (N=30) or conventional treatment (N=30). Treatment period will be 12 months. 2\. BP-AVALVE II: 200 patients will be randomized (1:1) to either strict BP control as in study 1 (N=100) or conventional care as in study 1 (N=100). Average treatment period will be 2 (1-3) years. 3\. BP-AVALVE III: Patients from BP-AVALVE-II continue in the randomized design until they develop symptoms of AS or have been followed for 10 (7-13) years. Patients will be reexamined at the end of the study period or in case they develop symptoms or LV failure and thus indication of valve replacement. Since the medicinal products used in this study is not the subject of the trial, the Danish Medicines Agency has classified this study as a clinical trial, in which medicinal products are used as a tool to induce a well-known physiological response. Therefor no further approval from the Danish Medicine Agency is required.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henrik Wiggers
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Heart Foundation
- Responsible party
- Sponsor-investigator, Henrik Wiggers, Aarhus University Hospital
- Investigators
- Henrik Wiggers, Principal investigator, Aarhus University Hospital, Department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613193
- Sponsor's protocol ID
- BP-AVALVE
- Acronym
- BP-AVALVE
- Status last verified
- Sep 2026
- First submitted
- 9 Jul 2020
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No