Patients with chronic heart failure and resting heart rate of = 75 bmp
Conditions
Interventions
Trade Name: Procoralan
Product Name: Procoralan
Pharmaceutical Form: Film-coated tablet and gastro-resistant granules in sachet
INN or Proposed INN: IVABRADINE
CAS Number: 155974-00-8
Concentration un
Sponsors
German Foundation for Chronically Ill
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Symptomatic heart failure with reduced left ventricular function caused by dilated cardiomyopathy (DCM) or ischemic cardiomyopathy (ICMP) •Heart rate = 75 bpm •NYHA Class II-IV •Sinus rhythm •Cognitive capacity •Age = 18 years •Stable HF medication including beta-blocker •Dose of beta-blocker = 50% of advised dose according to German product information or beta-blocker naive patient •Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: •Pregnancy •Systolic blood pressure < 95 mm Hg Cardiac decompensation within the last 8 weeks prior to recruitment •Significantly reduced renal function (GFR < 30) •Planned invasive medical intervention within the next 8 weeks •Lack of communication skills •Permanent atrial fibrillation and/or paroxysmal AF documented in two ECGs •Implanted active CRT-Device or active pacemaker •Patients with a contraindication for beta-blocker therapy •Patients under current Ivabradine-therapy •Patients paticipats in a competing clinical trial (identical/overlapping) inclusion criteria •Patients living in a geographic region without sufficient cell network coverage
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Within one month (28 days ± 7 days), patients with CHF under telemedical control and a resting heart rate of = 75 bpm will achieve a resting heart rate of = 70 bpm more often if they are treated with a combination of Ivabradine and beat-blocker compared to a therapy with beta-blocker alone.;Secondary Objective: After one month (T1): •How many patients reach a heart rate = 70 bpm? •What is the mean difference in heart rate compared to a heart rate of 70 bpm? •What is the mean reduction of hear rate? •What is the change in quality of life? •What is the change in NYHA classification? •What is the change of the 6-minute walk test? •Does the compliance differ between the groups? After 4 month: •How differs the progress in therapy and the therapy success between an early and a late entry of Ivabradin into the therapy?;Primary end point(s): Resting heart rate = 70 bpm at T1;Timepoint(s) of evaluation of this end point: 28 (+/-7) days after individual start of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Difference between heart rate and target level of 70 bpm at T1 •Mean reduction in heart rate between T0 and T1 •Changes in KCCQ from T0 to T1 •Changes in EQ-5D from T0 to T1 •Changes in NYHA classification from T0 to T1 •Changes in 6 minute walk test from T0 to T1 •Therapy compliance in T1 •Drop outs;Timepoint(s) of evaluation of this end point: 28 (+/-7) days after individual start of the study | — |
Countries
Germany
Contacts
Public ContactClinical Trial Coordinator
German Foundation for Chronically Ill
Outcome results
None listed