Heart Rate Reduction in Heart Failure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by IRCCS San Raffaele.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT01178528
First received: April 19, 2010
Last updated: August 9, 2010
Last verified: April 2010
  Purpose

Patients with heart failure (HF) have a limited exercise tolerance,few pharmachological 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.


Condition Intervention Phase
Heart Failure
Drug: ivabradine
Drug: Carvedilol/Ivabradine
Drug: Carvedilol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Ivabradine, Carvedilol or Their Combination in Patients With Heart Failure

Resource links provided by NLM:


Further study details as provided by IRCCS San Raffaele:

Primary Outcome Measures:
  • Exercise tolerance assessed by 6 minute walking test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    exercise tolerance assessed by physician supervised 6 minute walking test


Secondary Outcome Measures:
  • Quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    quality of life assessed by both a visual analog scale and by a SF36 questionnaire


Estimated Enrollment: 120
Study Start Date: September 2009
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ivabradine
7.5 mg bd
Drug: ivabradine
7.5 mg bd
Active Comparator: Carvedilol
up to 25 mg bd
Drug: Carvedilol
25 mg bd
Experimental: Carvedilol Ivabradine
up to 12.5/5 mg bd
Drug: Carvedilol/Ivabradine
up to 12.5/5 mg bd

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 Class II III 6MW tolerance between 200 and 400 m Stable medications for the past 3 months

Treatment Ivabradine up to 7.5 mg bd Carvedilol up to 25 mg bd Carvedilol Ivabradine up to 12.5/5 mg bd

Efficacy measure Intention to treat Exercise tolerance Quality of life

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 6MWT <100 m or >400 m
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01178528

Contacts
Contact: Giuseppe MC Rosano, MD, PhD 0652252310 giuseppe.rosano@sanraffaele.it
Contact: Giuseppe Marazzi, MD 0652252309 guiseppe.marazzi@sanraffaele.it

Locations
Italy
IRCCS San Raffaele Recruiting
Roma, Italy, 00100
Contact: Giuseppe MC Rosano, MD, PhD    0652252310    giuseppe.rosano@sanraffaele.it   
Principal Investigator: Maurizio Volterrani, MD         
Centre for Clinical and Basic Research - IRCCS San Raffaele Recruiting
Roma, Italy, 00100
Contact: Giuseppe Caminiti, MD    0652252321    giuseppe.caminiti@sanraffaele.it   
Sub-Investigator: Giuseppe Caminiti, MD         
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
Principal Investigator: Maurizio Volterrani, MD IRCCS San Raffaele
Study Chair: Giuseppe MC Rosano, MD, PhD IRCCS San Raffaele
Study Director: Cristiana Vitale, MD, PhD IRCCS San Raffaele
  More Information

Additional Information:
Publications:
Responsible Party: Giuseppe M.C. Rosano, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT01178528     History of Changes
Other Study ID Numbers: CTG001-07
Study First Received: April 19, 2010
Last Updated: August 9, 2010
Health Authority: Italy: Ministry of Health

Keywords provided by IRCCS San Raffaele:
heart failure
heart rate
ivabradine
carvedilol

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Carvedilol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists

ClinicalTrials.gov processed this record on August 21, 2014