Blood Pressure Reduction in Patients With Asymptomatic Aortic VALVE Stenosis

NCT04613193 | Recruiting

• 1 other identifier: BP-AVALVE
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 6

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:

1. 1.Strict BP control for 12 months reduces the progression of LV remodelling compared to conventional treatment.
2. 2.Strict BP control for 2 years reduces the increase in aortic valve calcification and LV remodelling compared to conventional treatment.
3. 3.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

Keywords

Aortic Valve Stenosis; Hypertension; Heart failure

Outcome Measures

Primary Outcomes (3)

• Change in LV mass

  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

  Cardiac CT and Echocardiography

  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.

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

Secondary Outcomes (11)

• LV mass-cavity ratio.

  Through study completion, an average of 1 year

• LV myocardial fibrosis

  Through study completion, an average of 1 year

• Myocardial perfusion during rest and stress

  Through study completion, an average of 1 year

• Aortic peak and mean gradients

  Through study completion, an average of 1 year

• Aortic valve area

  Through study completion, an average of 1 year

Study Arms (2)

Strict BP intervention group

ACTIVE COMPARATOR

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

Other: Blood presssure reduction

Conventional BP control group

OTHER

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

Other: Blood presssure reduction

Interventions

Blood presssure reduction OTHER

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

Conventional BP control group; Strict BP intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Henrik Wiggers: lead
• Danish Heart Foundation: collaborator

Study Sites (6)

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

Aarhus, Denmark

RECRUITING

Dept. of Cardiology, Herning Hospital

Herning, Denmark

NOT YET RECRUITING

Dept. of cardiology, Horsens Hospital

Horsens, Denmark

NOT YET RECRUITING

Dept. of cardiology, Randers Hospital

Randers, Denmark

NOT YET RECRUITING

Silkeborg Hospital

Silkeborg, Denmark

NOT YET RECRUITING

Dept. of cardiology, Viborg Hospital

Viborg, Denmark

NOT YET RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis; Essential Hypertension; Heart Failure; Hypertension

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Vascular Diseases

Study Officials

• Henrik Wiggers

  Aarhus University Hospital, Department of Cardiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Henrik Wiggers, MD, PhD

CONTACT

henrikwiggers@dadlnet.dk

Jonas A Povlsen, MD

CONTACT

+452270282; jonapovl@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant, Associate professor, MD, PhD, DMSc

Model Details: 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.

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: November 3, 2020
• Study Start: March 1, 2019
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): June 1, 2031
• Last Updated: November 3, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (6)