Heart Failure With Normal Ejection Fraction (HFNEF) in Hemodialysed Patients: Beneficial Effect of Ivabradine

NCT ID: NCT01373619

Last Updated: 2012-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-01-31

Brief Summary

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Heart failure with normal ejection fraction is often under diagnosed and certainly under treated in hemodialyzed patients. Because of the benefit of reducing heart rate, ivabradine, a pure heart-rate lowering agent without effects on blood pressure, is of potential therapeutic utility.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IVABRADINE, HEART FAILURE WITH NORMAL EF

Patient on hemodialysis with Heart failure with normal ejection fraction treated with ivabradine titrated to 7.5 mg BID to assess changes in echocardiography diastolic function and NYHA class and 6-minutes walking test

Group Type EXPERIMENTAL

Ivabradine

Intervention Type DRUG

ivabradine titrated to 7.5 mg BID

Interventions

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Ivabradine

ivabradine titrated to 7.5 mg BID

Intervention Type DRUG

Other Intervention Names

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Procoralan Corlentor

Eligibility Criteria

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Inclusion Criteria

* hemodialyzed patients
* signs and symptoms of heart failure with normal ejection fraction
* sinus rhythm

Exclusion Criteria

* atrial fibrillation/atrial flutter
* valvular heart disease
* unstable angina
* hospitalization for heart failure prior 3 months
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Campania Luigi Vanvitelli

OTHER

Sponsor Role lead

Responsible Party

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Second University of Naples

Principal Investigators

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Gennaro Cice, MD

Role: PRINCIPAL_INVESTIGATOR

University of Campania Luigi Vanvitelli

Locations

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Chair of Cardiology Second Univesity of Naples

Naples, , Italy

Site Status

Countries

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Italy

Other Identifiers

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HFNEF-IVA-DIAL

Identifier Type: -

Identifier Source: org_study_id

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