Left ventricular reverse remodelling after aortic valve replacement in severe valvular aortic stenosis - effect of blockade of the angiotensin-II receptor

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001930-34-DK

Enrollment

140

Registered

2005-11-25

Start date

2005-11-25

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with severe aortic valve stenosis treated with Aortic Valve Replacement (AVR)

Interventions

Trade Name: Atacand (Candesartancilexetil) Product Name: Atacand Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria 1. Symptomatic severe AVS referred for valve replacement (mechanic prosthesis or bioprosthesis) at Odense University Hospital 2. Age > 18 years 3. Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria 1. Severe renal failure (s-creatinine >300 mmole/l) 2. Moderate or severe hepatic failure (ALAT >150 IU/l) 3. Moderate or severe LV systolic dysfunction (LVEF<40%) 4. Known intolerance for angiotensin II receptor antagonist (Atacand) 5. Unwilling to participate in the study 6. Poor echocardiographic window 7. Women of childbearing potential (only postmenopausal women)

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary objectives 1.In a consecutive population undergoing AVR for symptomatic AVS to compare a.LV mass index b.LA volume index c.plasma nt-pro BNP concentration after 12 months treatment with Atacand compared with conventional treatment ;Secondary Objective: 1.In a consecutive population undergoing AVR for symptomatic AVS to compare: a.Echocardiographic diastolic E/e’ ratio b.Overall LV function assessed by the Doppler echocardiographic Tei Index d.Regional LV function assessed with echocardiographic tissue Doppler imaging e.LV end systolic and end diastolic volume index after 12 months treatment with Atacand compared with conventional treatment. 1. the occurence and atrial arrhythmias assessed with 48h Holther after 12 months treatment with Atacand compared with conventional management. 2. exercise capacity after 12 months treatment with Atacand compared with conventional management. 3. assess serial changes in LV diastolic, overall LV function and regional LV systolic function 12 months after valve replacement 4. assess serial changes in plasma nt-pro BNP, ANP, and renin 12 months after valve replacement ;Primary end point(s): Primary end points Left ventricular mass index assessed by echocardiography, left atrial volume and N terminal pro brain natriuretic peptide concentration 12 months after valve replacement. Secondary end point Echocardiographic assessment of diastolic function, occurrence of atrial arrhytmias 12 months after AVR.	—

Measure

Time frame

Main Objective: Primary objectives 1.In a consecutive population undergoing AVR for symptomatic AVS to compare a.LV mass index b.LA volume index c.plasma nt-pro BNP concentration after 12 months treatment with Atacand compared with conventional treatment ;Secondary Objective: 1.In a consecutive population undergoing AVR for symptomatic AVS to compare: a.Echocardiographic diastolic E/e’ ratio b.Overall LV function assessed by the Doppler echocardiographic Tei Index d.Regional LV function assessed with echocardiographic tissue Doppler imaging e.LV end systolic and end diastolic volume index after 12 months treatment with Atacand compared with conventional treatment. 1. the occurence and atrial arrhythmias assessed with 48h Holther after 12 months treatment with Atacand compared with conventional management. 2. exercise capacity after 12 months treatment with Atacand compared with conventional management. 3. assess serial changes in LV diastolic, overall LV function and regional LV systolic function 12 months after valve replacement 4. assess serial changes in plasma nt-pro BNP, ANP, and renin 12 months after valve replacement ;Primary end point(s): Primary end points Left ventricular mass index assessed by echocardiography, left atrial volume and N terminal pro brain natriuretic peptide concentration 12 months after valve replacement. Secondary end point Echocardiographic assessment of diastolic function, occurrence of atrial arrhytmias 12 months after AVR.

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Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026