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Clinical Trials/EUCTR2012-002742-20-IT
EUCTR2012-002742-20-IT
Active, not recruiting
Phase 1

Effect of ivabradine versus placebo on cardiac function, exercise capacity, and neuroendocrine activation in patients with Chronic Heart Failure with Preserved left ventricular Ejection FractionAn 8-month, randomised double-blind, placebo controlled, international, multicentre study.

Institut de Recherches Internationales Servier0 sites400 target enrollmentFebruary 27, 2013
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ConditionsHeart failure with preserved left ventricular ejection fractionMedDRA version: 15.1Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
DrugsPROCORALAN

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Heart failure with preserved left ventricular ejection fraction
Sponsor
Institut de Recherches Internationales Servier
Enrollment
400
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 27, 2013
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

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

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.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Not Applicable
Effect of ivabradine versus placebo on cardiac function and on capacity to perform exercise in patients suffering from diastolic heart failure.Heart failure with preserved left ventricular ejection fractionMedDRA version: 18.1Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
EUCTR2012-002742-20-PTInstitut de Recherches Internationales Servier400
Active, not recruiting
Not Applicable
Effect of ivabradine versus placebo on cardiac function and on capacity to perform exercise in patients suffering from diastolic heart failure.Heart failure with preserved left ventricular ejection fractionMedDRA version: 17.1Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
EUCTR2012-002742-20-BEInstitut de Recherches Internationales Servier400
Active, not recruiting
Phase 1
Effect of ivabradine versus placebo on cardiac function and on capacity to perform exercise in patients suffering from diastolic heart failure.Heart failure with preserved left ventricular ejection fractionMedDRA version: 18.1Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
EUCTR2012-002742-20-DEInstitut de Recherches Internationales Servier400
Active, not recruiting
Phase 1
Effect of ivabradine versus placebo on cardiac function and on capacity to perform exercise in patients suffering from diastolic heart failure.Heart failure with preserved left ventricular ejection fractionMedDRA version: 17.0Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
EUCTR2012-002742-20-ATInstitut de Recherches Internationales Servier400
Active, not recruiting
Phase 1
Effect of ivabradine versus placebo on cardiac function and on capacity to perform exercise in patients suffering from diastolic heart failure.
EUCTR2012-002742-20-ESaboratorios Servier S.L.400