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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01373619
• Other study ID #: HFNEF-IVA-DIAL
• Status: Completed
• Phase: Phase 4
• First received: May 25, 2011
• Last updated: January 18, 2012
• Start date: January 2010
• Est. completion date: January 2012

Study information

• Verified date: January 2010
• Source: Second University of Naples
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy:Ministery of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Ivabradine
ivabradine titrated to 7.5 mg BID

Locations

Country	Name	City	State
Italy	Chair of Cardiology Second Univesity of Naples	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Second University of Naples

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Echocardiofic changes of diastolic left ventricular function	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.	baseline, 1, 3, 6, 9, 12 months	No
Secondary	changes in NYHA class	Measures of New York Heart Association functional class stratified I to IV at baseline and at each scheduled time.	baseline, 1,3,6,9,12 months	Yes
Secondary	changes in 6-minutes walking test	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.	baseline, 1,3,6,9,12 months	Yes