Blood Pressure Reduction in Patients With Asymptomatic Aortic VALVE Stenosis

Heart Failure Clinical Trial

— BP-AVALVE  

Official title:

Blood Pressure Reduction in Patients With Asymptomatic Aortic VALVE Stenosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04613193
• Other study ID #: BP-AVALVE
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: June 1, 2031

Study information

• Verified date: October 2020
• Source: Aarhus University Hospital
• Contact: Henrik Wiggers, MD, PhD
• Email: henrikwiggers[@]dadlnet.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 1, 2031
• Est. primary completion date: January 1, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic
• Essential Hypertension
• Heart Failure
• Hypertension
• Hypertension,Essential

Intervention

Other:
• Blood presssure reduction
Patients will be uptitrated in antihypertensive treatment until the treatment target is achieved.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Henrik Wiggers	Danish Heart Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in LV mass	LV mass as measured by cardiac MR	Changes will be evaluated after an expected average of 12 months treatment
Primary	Change in aortic valve CT calcium volume and aortic peak gradient	Cardiac CT and Echocardiography	Changes will be evaluated after an expected average of 2-3 years treatment
Primary	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.	Will be evaluated after an expected average of 7-13 years of treatment
Secondary	LV mass-cavity ratio.	Cardiac MR	Through study completion, an average of 1 year
Secondary	LV myocardial fibrosis	Cardiac MR	Through study completion, an average of 1 year
Secondary	Myocardial perfusion during rest and stress	Cardiac MR	Through study completion, an average of 1 year
Secondary	Aortic peak and mean gradients	Echocardiography	Through study completion, an average of 1 year
Secondary	Aortic valve area	Echocardiography	Through study completion, an average of 1 year
Secondary	Left ventricular global longitudinal strain	Echocardiography	Through study completion, an average of 1 year
Secondary	Valvolu-arterial impedance	Echocardiography	Through study completion, an average of 1 year
Secondary	NT-proBNP	Blood test	Baseline and follow-up
Secondary	Minnesota living with heart failure questionnaire	Questionnaire	Through study completion, an average of 1 year
Secondary	Ambulatory 24-hour blood pressure measurement	Ambulatory 24-hour blood pressure measurement	Through study completion, an average of 1 year
Secondary	Dimensions and aortic calcium score of the thoracic aorta.	cardiac CT	Through study completion, an average of 2 years