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Heart FailurePhase 3CARVIVA-HFNCT01178528

Heart Rate Reduction in Heart Failure

A Phase 3 study testing ivabradine, "Drug:Carvedilol" and "Drug:Ivabradine" and Carvedilol in people with Heart Failure, run by IRCCS San Raffaele at 2 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 years and older
Conditions the study is for
Heart Failure
What is being tested?
ivabradine, "Drug:Carvedilol" and "Drug:Ivabradine" and Carvedilol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
2 sitesItaly
Study dates
Sep 2009to Oct 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

  • Centre for Clinical and Basic Research - IRCCS San Raffaele

    Roma, Italy, 00100

  • IRCCS San Raffaele

    Roma, Italy, 00100

Other trials in Italy

About this study

Official title: Effect of Ivabradine, Carvedilol or Their Combination in Patients With Heart Failure

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.

Read the 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

Conditions
Heart Failure
Being tested
ivabradine, "Drug:Carvedilol" and "Drug:Ivabradine", Carvedilol
Keywords
heart failure, heart rate, ivabradine, carvedilol
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ivabradineDrug

    7.5 mg bd

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

    up to 12.5/5 mg bd

  • CarvedilolDrug

    25 mg bd

Study groups in NCT01178528
Study groupRoleWhat they receive
IvabradineExperimental7.5 mg bd
Receives: Drug: ivabradine
CarvedilolActive comparatorup to 25 mg bd
Receives: Drug: Carvedilol
"Drug:Carvedilol" and "Drug:Ivabradine"Experimentalup to 12.5/5 mg bd
Receives: Drug: "Drug:Carvedilol" and "Drug:Ivabradine"

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months

  2. 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.

    Measured: 3 months

Secondary outcomes (2)

  1. Quality of Life

    Quality of life (QoL) was evaluated using the Visual Analogue Scale (VAS) which is a global measurement of QoL, allowing a subjective assessment of the impact of the disease and treatment. Patients are asked to indicate their current state in a line from 0 (worst state) to 10 (best state), with higher values therefore representing a better outcome.

    Measured: 3 months

  2. New York Heart Association (NYHA) Class

    The 1994 NYHA Classification system is a measure of functional status. It was designed for clinical assessment of patients by physicians as NYHA class I, II, III, or IV, on the basis of patient's limitations in physical activities caused by cardiac symptoms.

    Class I describes patients with cardiovascular disease (CVD) but without resulting limitation of physical activity. There is no objective evidence of CVD.

    Class II describes patients with CVD resulting in slight limitation of physical activity. There is objective evidence of minimal CVD.

    Class III describes patients with CVD resulting in marked limitation of physical activity. There is objective evidence of moderately severe CVD.

    Class IV describes patients with CVD resulting in inability to carry on any physical activity without discomfort. There is objective evidence of severe CVD.

    Here we report data on number of patients showing an improvement by at least one NYHA class according to treatment allocation.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2010 (estimated)
  2. Study startSep 2009
  3. Primary completionJun 2010
  4. Study completionOct 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01178528
Sponsor's protocol ID
CTG001-07
Acronym
CARVIVA-HF
Status last verified
Sep 2014
First submitted
19 Apr 2010
Last updated
30 Sep 2014
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 19944362

  • 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.

    PubMed 19892778

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ivabradine, "Drug:Carvedilol" and "Drug:Ivabradine" and Carvedilol in people with Heart Failure, run by IRCCS San Raffaele at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Exercise Tolerance Assessed by 6 Minute Walking Test (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01178528, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2014.

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Heart Rate Reduction in Heart Failure (NCT01178528) | AzTrials