Heart Rate Reduction in Heart Failure

NCT01178528 | Completed Phase 3 Results DMC

• 1 other identifier: CTG001-07
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Failure

Keywords

heart failure; heart rate; ivabradine; carvedilol

Outcome Measures

Primary Outcomes (2)

• Exercise Tolerance Assessed by 6 Minute Walking Test

  Distance measured at 6 minute walking test. The 6 minute walking test was performed according to standardised procedure at baseline, before inclusion (at least 1 week after baseline evaluation), and at the end of the study. Patients who had not done at least two tests in the past underwent two practice 6 minute walking tests at least 3 days apart. Results are expressed in terms of distance walked (metres). The test was supervised by a physical therapist. Patients were asked to walk at their own maximal pace a 100 m long hospital corridor. At the beginning of the last (6th) minute of the test a standard phrase of encouragement was told. Patients were allowed to stop if signs or symptoms of significant distress occurred (dyspnea, angina), through they were instructed to resume walking as soon as possible.

  3 months

• Maximal Oxygen Consumption

  Functional capacity was assessed by means of a cardiopulmonary exercise test with a bicycle ergometer with gas exchange monitoring (Vmax 29 C, SensorMedics). Peak oxygen consumption was defined as the maximal oxygen consumption (MVO2) observed during exercise.

  3 months

Secondary Outcomes (2)

• Quality of Life

  3 months

• New York Heart Association (NYHA) Class

  3 months

Study Arms (3)

Ivabradine

EXPERIMENTAL

7.5 mg bd

Drug: ivabradine

Carvedilol

ACTIVE COMPARATOR

up to 25 mg bd

Drug: Carvedilol

"Drug:Carvedilol" and "Drug:Ivabradine"

EXPERIMENTAL

up to 12.5/5 mg bd

Drug: "Drug:Carvedilol" and "Drug:Ivabradine"

Interventions

ivabradine DRUG

7.5 mg bd

Ivabradine

"Drug:Carvedilol" and "Drug:Ivabradine" DRUG

up to 12.5/5 mg bd

"Drug:Carvedilol" and "Drug:Ivabradine"

Carvedilol DRUG

25 mg bd

Carvedilol

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (2)

Centre for Clinical and Basic Research - IRCCS San Raffaele

Roma, Italy, 00100, Italy

Location

IRCCS San Raffaele

Roma, Italy, 00100, Italy

Location

Related Publications (2)

• 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.

  PMID: 19944362 BACKGROUND

• 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.

  PMID: 19892778 BACKGROUND

Related Links

• European Society Cardiology guidelines

MeSH Terms

Conditions

Heart Failure

Interventions

Ivabradine; Carvedilol

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: G Rosano
• Organization: IRCCS San Raffaele

giuseppe.rosano@sanraffaele.it

0652252309

Study Officials

• Maurizio Volterrani, MD

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

• Giuseppe MC Rosano, MD, PhD

  IRCCS San Raffaele

  STUDY CHAIR

• Cristiana Vitale, MD, PhD

  IRCCS San Raffaele

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigato

Study Record Dates

• First Submitted: April 19, 2010
• First Posted: August 10, 2010
• Study Start: September 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: October 1, 2010
• Last Updated: September 30, 2014
• Results First Posted: September 30, 2014

Record last verified: 2014-09

Locations

IT (2)