Blood Pressure Reduction in Patients With Asymptomatic Aortic VALVE Stenosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2031-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Aortic Valve Stenosis Hypertension,Essential Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Strict BP intervention group

SBP \< 120 mmHg and a reduction in SBP of \>= 15 mmHg

Group Type ACTIVE_COMPARATOR

Blood presssure reduction

Intervention Type OTHER

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

Conventional BP control group

In patients \< 75 years: SBP = 135 mmHg In patients \>/= 75 years: SBP = 145 mmHg

Group Type OTHER

Blood presssure reduction

Intervention Type OTHER

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

Interventions

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Blood presssure reduction

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Henrik Wiggers

Consultant, Associate professor, MD, PhD, DMSc

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Henrik Wiggers

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital, Department of Cardiology

Locations

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

Aarhus, , Denmark

Site Status RECRUITING