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

University of Campania "Luigi Vanvitelli"

Status and phase: Completed; Phase 4

Conditions: Heart Failure

Treatments: Drug: Ivabradine

Study type: Interventional

Funder types: Other

Identifiers

NCT01373619

HFNEF-IVA-DIAL

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

IVABRADINE, HEART FAILURE WITH NORMAL EF

Experimental group

Description:

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

Treatment:

Drug: Ivabradine