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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01373619

Enrollment

150

Registered

2011-06-15

Start date

2010-01-31

Completion date

2012-01-31

Last updated

2012-01-19

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

Conditions

Heart Failure

Keywords

Heart failure with normal ejection fraction, hemodialysis patients, ivabradine, Echocardiography, NYHA class, 6-minutes walking test

Brief summary

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.

Interventions

DRUGIvabradine

ivabradine titrated to 7.5 mg BID

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Echocardiofic changes of diastolic left ventricular function	baseline, 1, 3, 6, 9, 12 months	Measures of diastolic left ventricular function (E and A velocity and deceleration time of mitral inflow and Doppler-Tissue-Imaging E velocity and their ratio) were assessed at baseline and at each scheduled time.

Secondary

Measure	Time frame	Description
changes in NYHA class	baseline, 1,3,6,9,12 months	Measures of New York Heart Association functional class stratified I to IV at baseline and at each scheduled time.
changes in 6-minutes walking test	baseline, 1,3,6,9,12 months	American Thoracic Society At baseline and at each scheduled time a 6-minutes walking test were performed according ATS Statement. The following measures were analysed at starting and ending test: heart rate; blood pressure, dyspnea according the Borg scale, fatigue according the Borg scale, Spo2%;distance walked, symptoms.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026