Blood Pressure Reduction in Patients With Asymptomatic Aortic VALVE Stenosis (BP-AVALVE)

September 10, 2026 updated by: Henrik Wiggers

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Jonas A Povlsen, MD
  • Phone Number: +452270282
  • Email: jonapovl@rm.dk

Study Locations

  • Denmark
      • Aarhus, Denmark
        • Dept. of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99
      • Herning, Denmark
        • Dept. of Cardiology, Herning Hospital
      • Horsens, Denmark
        • Dept. of cardiology, Horsens Hospital
      • Randers, Denmark
        • Dept. of cardiology, Randers Hospital
      • Silkeborg, Denmark
        • Silkeborg Hospital
      • Viborg, Denmark
        • Dept. of cardiology, Viborg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Strict BP intervention group
SBP < 120 mmHg and a reduction in SBP of >= 15 mmHg
Other: Blood presssure reduction
Patients will be uptitrated in antihypertensive treatment until the treatment target is achieved.
Other: Conventional BP control group
In patients < 75 years: SBP = 135 mmHg In patients >/= 75 years: SBP = 145 mmHg
Other: Blood presssure reduction
Patients will be uptitrated in antihypertensive treatment until the treatment target is achieved.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Changes will be evaluated after an expected average of 12 months treatment
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
Changes will be evaluated after an expected average of 2-3 years treatment
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.
Will be evaluated after an expected average of 7-13 years of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
LV mass-cavity ratio.
Time Frame: Through study completion, an average of 1 year
Cardiac MR
Through study completion, an average of 1 year
LV myocardial fibrosis
Time Frame: Through study completion, an average of 1 year
Cardiac MR
Through study completion, an average of 1 year
Myocardial perfusion during rest and stress
Time Frame: Through study completion, an average of 1 year
Cardiac MR
Through study completion, an average of 1 year
Aortic peak and mean gradients
Time Frame: Through study completion, an average of 1 year
Echocardiography
Through study completion, an average of 1 year
Aortic valve area
Time Frame: Through study completion, an average of 1 year
Echocardiography
Through study completion, an average of 1 year
Left ventricular global longitudinal strain
Time Frame: Through study completion, an average of 1 year
Echocardiography
Through study completion, an average of 1 year
Valvolu-arterial impedance
Time Frame: Through study completion, an average of 1 year
Echocardiography
Through study completion, an average of 1 year
NT-proBNP
Time Frame: Baseline and follow-up
Blood test
Baseline and follow-up
Minnesota living with heart failure questionnaire
Time Frame: Through study completion, an average of 1 year
Questionnaire
Through study completion, an average of 1 year
Ambulatory 24-hour blood pressure measurement
Time Frame: Through study completion, an average of 1 year
Ambulatory 24-hour blood pressure measurement
Through study completion, an average of 1 year
Dimensions and aortic calcium score of the thoracic aorta.
Time Frame: Through study completion, an average of 2 years
cardiac CT
Through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Henrik Wiggers

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Danish Heart Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Henrik Wiggers, Aarhus University Hospital, Department of Cardiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 3, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BP-AVALVE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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