Back to resultsHeart Failure With Normal Ejection Fraction (HFNEF) in Hemodialysed Patients: Beneficial Effect of Ivabradine
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Ivabradine
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart failure with normal ejection fraction, hemodialysis patients, ivabradine, Echocardiography, NYHA class, 6-minutes walking test
Eligibility Criteria
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
Sites / Locations
- Chair of Cardiology Second Univesity of Naples
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IVABRADINE, HEART FAILURE WITH NORMAL EF
Arm 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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
changes in NYHA class
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
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.
Full Information
NCT ID
NCT01373619
First Posted
May 25, 2011
Last Updated
January 18, 2012
Sponsor
University of Campania "Luigi Vanvitelli"
1. Study Identification
Unique Protocol Identification Number
NCT01373619
Brief Title
Heart Failure With Normal Ejection Fraction (HFNEF) in Hemodialysed Patients: Beneficial Effect of Ivabradine
Official Title
Heart Failure With Normal Ejection Fraction (HFNEF) in Hemodialysed Patients: Beneficial Effect of Ivabradine
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Campania "Luigi Vanvitelli"
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure with normal ejection fraction, hemodialysis patients, ivabradine, Echocardiography, NYHA class, 6-minutes walking test
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IVABRADINE, HEART FAILURE WITH NORMAL EF
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Ivabradine
Other Intervention Name(s)
Procoralan, Corlentor
Intervention Description
ivabradine titrated to 7.5 mg BID
Primary Outcome Measure Information:
Title
Echocardiofic changes of diastolic left ventricular function
Description
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.
Time Frame
baseline, 1, 3, 6, 9, 12 months
Secondary Outcome Measure Information:
Title
changes in NYHA class
Description
Measures of New York Heart Association functional class stratified I to IV at baseline and at each scheduled time.
Time Frame
baseline, 1,3,6,9,12 months
Title
changes in 6-minutes walking test
Description
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.
Time Frame
baseline, 1,3,6,9,12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gennaro Cice, MD
Organizational Affiliation
University of Campania "Luigi Vanvitelli"
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chair of Cardiology Second Univesity of Naples
City
Naples
ZIP/Postal Code
80100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Heart Failure With Normal Ejection Fraction (HFNEF) in Hemodialysed Patients: Beneficial Effect of Ivabradine
We'll reach out to this number within 24 hrs