Clinical trial NCT01178528: Heart Rate Reduction in Heart Failure
Official title: Effect of Ivabradine, Carvedilol or Their Combination in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure
Keywords: heart failure
heart rate
ivabradine
carvedilol
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2010-08-10
Enrollment: 121
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with heart failure (HF) have a limited exercise tolerance,few pharmacological interventions have been proven effective in improving exercise capacity. At the presence there i conflicting evidence on the effectiveness of beta-blockers on exercise capacity. Ivabradine has been shown to improve prognosis in patients with ischemic heart disease, left ventricular dysfunction and heart rate \> 70 bpm. The association of ivabradine and atenolol has been proven effective in increasing exercise tolerance in patients with ischemic heart disease. Aim of the present study is to evaluate the effect of heart rate reduction with ivabradine, carvedilol or their combination in patients with heart failure of ischemic origin.

Detailed description: Patients with chronic heart failure of ischemic origin (120) Stable coronary artery disease Acute coronary syndromes \> 3 months Revascularization procedures \> 3 months Naive on heart rate reducing agents New York Heart Association (NYHA) Class II III 6 minute walking test (6MW) tolerance between 200 and 400 m Stable medications for the past 3 months

Treatment Ivabradine up to 7.5 mg b.i.d. Carvedilol up to 25 mg b.i.d. Carvedilol and Ivabradine up to 12.5/5 mg b.i.d.

Efficacy measure Intention to treat Exercise tolerance Quality of life

Eligibility criteria: Inclusion Criteria:

* heart failure II-III
* ischemic origin
* stable medications from at least 3 months
* \> 3 months from an acute ischemic syndrome or revascularization procedure
* naive on heart rate reducing agents

Exclusion Criteria:

* bradycardia
* hypersensitivity or contraindications to study drugs
* exercise tolerance at 6 minute walking test \<100 m or \>400 m

Primary outcomes:
measure: Exercise Tolerance Assessed by 6 Minute Walking Test
timeFrame: 3 months
measure: Maximal Oxygen Consumption
timeFrame: 3 months
Secondary outcomes:
measure: Quality of Life
timeFrame: 3 months
measure: New York Heart Association (NYHA) Class
timeFrame: 3 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Centre for Clinical and Basic Research - IRCCS San Raffaele
city: Roma
country: Italy
facility: IRCCS San Raffaele
Study officials:
affiliation: IRCCS San Raffaele
name: Maurizio Volterrani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS San Raffaele
name: Giuseppe MC Rosano, MD, PhD
role: STUDY_CHAIR
affiliation: IRCCS San Raffaele
name: Cristiana Vitale, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Fasullo S, Cannizzaro S, Maringhini G, Ganci F, Giambanco F, Vitale G, Pinto V, Migliore G, Torres D, Sarullo FM, Paterna S, Di Pasquale P. Comparison of ivabradine versus metoprolol in early phases of reperfused anterior myocardial infarction with impaired left ventricular function: preliminary findings. J Card Fail. 2009 Dec;15(10):856-63. doi: 10.1016/j.cardfail.2009.05.013. Epub 2009 Jul 3.
citation: Swedberg K, Komajda M, Bohm M, Borer JS, Ford I, Tavazzi L. Rationale and design of a randomized, double-blind, placebo-controlled outcome trial of ivabradine in chronic heart failure: the Systolic Heart Failure Treatment with the I(f) Inhibitor Ivabradine Trial (SHIFT). Eur J Heart Fail. 2010 Jan;12(1):75-81. doi: 10.1093/eurjhf/hfp154. Epub 2009 Nov 5.