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

Primary Purpose

Aortic Valve Stenosis, Hypertension,Essential, Heart Failure

Status

Recruiting

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Blood presssure reduction

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring Aortic Valve Stenosis, Hypertension, Heart failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Strict BP intervention group

Conventional BP control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in LV mass

LV mass as measured by cardiac MR

Change in aortic valve CT calcium volume and aortic peak gradient

Cardiac CT and Echocardiography

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.

Secondary Outcome Measures

LV mass-cavity ratio.

Cardiac MR

LV myocardial fibrosis

Cardiac MR

Myocardial perfusion during rest and stress

Cardiac MR

Aortic peak and mean gradients

Echocardiography

Aortic valve area

Echocardiography

Left ventricular global longitudinal strain

Echocardiography

Valvolu-arterial impedance

Echocardiography

NT-proBNP

Blood test

Minnesota living with heart failure questionnaire

Questionnaire

Ambulatory 24-hour blood pressure measurement

Dimensions and aortic calcium score of the thoracic aorta.

cardiac CT

Full Information

NCT ID

NCT04613193

First Posted

July 9, 2020

Last Updated

October 27, 2020

Sponsor

Henrik Wiggers

Collaborators

Danish Heart Foundation

1. Study Identification

Unique Protocol Identification Number

NCT04613193

Brief Title

Blood Pressure Reduction in Patients With Asymptomatic Aortic VALVE Stenosis

Acronym

BP-AVALVE

Official Title

Blood Pressure Reduction in Patients With Asymptomatic Aortic VALVE Stenosis

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Recruiting

Study Start Date

March 1, 2019 (Actual)

Primary Completion Date

January 1, 2031 (Anticipated)

Study Completion Date

June 1, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Henrik Wiggers

Collaborators

Danish Heart Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Valve Stenosis, Hypertension,Essential, Heart Failure

Keywords

Aortic Valve Stenosis, Hypertension, Heart failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Strict BP intervention group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Conventional BP control group

Arm Type

Other

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Blood presssure reduction

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in LV mass

Description

LV mass as measured by cardiac MR

Time Frame

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

Title

Change in aortic valve CT calcium volume and aortic peak gradient

Description

Cardiac CT and Echocardiography

Time Frame

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

Title

Clinical composite endpoint:

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

LV mass-cavity ratio.

Description

Cardiac MR

Time Frame

Through study completion, an average of 1 year

Title

LV myocardial fibrosis

Description

Cardiac MR

Time Frame

Through study completion, an average of 1 year

Title

Myocardial perfusion during rest and stress

Description

Cardiac MR

Time Frame

Through study completion, an average of 1 year

Title

Aortic peak and mean gradients

Description

Echocardiography

Time Frame

Through study completion, an average of 1 year

Title

Aortic valve area

Description

Echocardiography

Time Frame

Through study completion, an average of 1 year

Title

Left ventricular global longitudinal strain

Description

Echocardiography

Time Frame

Through study completion, an average of 1 year

Title

Valvolu-arterial impedance

Description

Echocardiography

Time Frame

Through study completion, an average of 1 year

Title

NT-proBNP

Description

Blood test

Time Frame

Baseline and follow-up

Title

Minnesota living with heart failure questionnaire

Description

Questionnaire

Time Frame

Through study completion, an average of 1 year

Title

Ambulatory 24-hour blood pressure measurement

Description

Ambulatory 24-hour blood pressure measurement

Time Frame

Through study completion, an average of 1 year

Title

Dimensions and aortic calcium score of the thoracic aorta.

Description

cardiac CT

Time Frame

Through study completion, an average of 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Henrik Wiggers, MD, PhD

henrikwiggers@dadlnet.dk

First Name & Middle Initial & Last Name or Official Title & Degree

Jonas A Povlsen, MD

Phone

+452270282

jonapovl@rm.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Henrik Wiggers

Organizational Affiliation

Aarhus University Hospital, Department of Cardiology

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Aarhus

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Henrik Wiggers

Facility Name

Dept. of Cardiology, Herning Hospital

City

Herning

Country

Denmark

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Morten Bøttcher

Facility Name

Dept. of cardiology, Horsens Hospital

City

Horsens

Country

Denmark

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karen Kaae Dodt

Facility Name

Dept. of cardiology, Randers Hospital

City

Randers

Country

Denmark

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Liv Gøtzsche

Facility Name

Silkeborg Hospital

City

Silkeborg

Country

Denmark

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lars Frost

Facility Name

Dept. of cardiology, Viborg Hospital

City

Viborg

Country

Denmark

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jens Refsgaard

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Blood Pressure Reduction in Patients With Asymptomatic Aortic VALVE Stenosis

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