Effect of ivabradine versus placebo on cardiac function and on capacity to perform exercise in patients suffering from diastolic heart failure.

• Conditions: Heart failure with preserved left ventricular ejection fraction; MedDRA version: 18.0Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-002742-20-NL
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-19
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

- Male or female patients,
- Aged 50 years or older,
- Symptomatic Chronic Heart Failure of New York Heart Association (NYHA) class II or III for at least 3 months prior to selection,
- In stable clinical condition with regards to CHF symptoms for at least 4 weeks prior to selection,
- Documented sinus rhythm and HR superior or equal to 70 bpm on a resting standard 12-lead ECG at selection and inclusion,
- Left Ventricular Ejection Fraction superior or equal to 50% and E/e’ > 13 (E = early diastolic mitral flow velocity; e’ = mean of mitral annular lateral and septal proto diastolic velocities) or e’ lateral < 10 cm/s and e’ septal < 8 cm/s or LAVI > 34 mL/m² at selection,
- Documented NT-proBNP > 300 pg/mL or BNP > 100 pg/mL at selection.
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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

- Recent (less than 3 months) myocardial infarction or coronary revascularisation,
- Scheduled coronary revascularisation,
- Severe aortic or mitral stenosis, or severe aortic regurgitation, or severe primary mitral regurgitation,
- Scheduled surgery for valvular heart disease
- Congenital heart disease,
- Previous cardiac transplantation or on list for cardiac transplantation,
- Documented permanent atrial fibrillation or other cardiac arrhythmia that interfere with the sinus node function, or recent hospitalization for atrial fibrillation or other cardiac arrhythmia that interfere with the sinus node function within the last 3 months,
- Patients able to walk more than 450 meters within 6 minutes during the selection and the inclusion visits,
- Previous or current treatment with ivabradine.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified