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Heart FailureCARRYINGONNCT01216670

Cardiac Rhythm Monitoring After Acute Decompensation for Heart Failure

An observational study of Heart Failure, run by Medtronic Italia at 4 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

The CARRYING ON for heart failure (HF) study is a national, prospective, post market interventional, multi-center, open-label, pilot trial.The purpose of the study is to assess a short term and a long term period, incidence of pre-specified clinical and arrhythmic events in patients with a low ejection fraction (EF)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
remote patient's management
How many people
18 participants
Where
4 sitesItaly
Study dates
Feb 2011to May 2014
Phase
Observational
Are there results?
None posted in the registry

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

Study population: Hf patients without indication to permanent device implant (PM/ICD/CRT)

Who may be able to join

  • Subject with a history of at least one heart failure (HF) hospitalization (as defined in the European Society of Cardiology or American College of Cardiology/American Heart Association guidelines), emergency department (ED) visit, or urgent office visit necessitating intravenous (IV) diuretic or augmentation of oral diuretic, IV inotropic, or IV vasodilator or other HF parenteral therapy within 15 days prior to device implant
  • Subject has an implanted Reveal® XT device (less than 15 days post implant);
  • Ejection Fraction (EF) less than 40 percent
  • Patient with access to a telephone line
  • Patient or the patient's caregiver is willing and able to use the Medtronic CareLink® Network Monitor and to perform the required duties at home or has a family member or assistant perform those duties
  • Age greater than 18 years old
  • Patient is willing and able to comply with the Clinical Investigation plan and willing to remain available for follow-up visit, through study closure
  • Patient (or patient's legally authorized representative) is willing and able to sign and date the study Informed Consent

Who cannot join

  • New York Heart Association (NYHA) Class IV (chronic or ambulatory)
  • Planned or previous implant of implantable cardioverter-defibrillator or pacemaker device
  • Patient's life expectancy is less than one year due to non cardiovascular disorders, in the opinion of the physician
  • Severe chronic obstructive pulmonary disorder (COPD)
  • Chronic Atrial Fibrillation at time of enrollment
  • ST segment elevation at time of electrocardiogram
Show all 9Show fewer
  • Cognitive disease
  • Pregnancy or childbearing potential and not on reliable contraceptive
  • Anticipated compliance problem or participation in another competitive trial

Trial locations and contacts

4 sites in 1 country.

Italy4 sites

  • A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria

    Alessandria, Alessandria, 15100

  • A.O. Ospedale S. Anna di Como

    Como, Como, 22100

  • Policlinico di Monza

    Monza, Monza, 20052

  • Clinica San Gaudenzio

    Novara, Novara, 28100

Other trials in Italy

About this study

The CARRYING ON for heart failure (HF) study is a national, prospective, post market interventional, multi-center, open-label, pilot trial.The purpose of the study is to assess a short term and a long term period, incidence of pre-specified clinical and arrhythmic events in patients with a low ejection fraction (EF) that are hospitalized for acute cardiac decompensation.

Read the detailed description

The CARRYING ON for heart failure (HF) study is a national, prospective, post market interventional, multi-center, open-label, pilot trial designed in two phases.

The purpose of the study is to assess a short term (6 months follow-up - Phase 1) and a long term period (24 months follow-up - Phase 2), incidence of pre-specified clinical and arrhythmic events in patients with a low ejection fraction (EF) that are hospitalized for acute cardiac decompensation. A previously implanted Reveal® XT device will be used to collect heart rhythm information.

Conditions
Heart Failure
Being tested
remote patient's management
Keywords
Reveal® XT, Acute Heart Failure, Low Ejection Fraction, Reveal® XT implanted
Medical subject headings
Heart Failure

What participants receive

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

  • remote patient's managementBehavioural

    Also called home monitoring

    scheduled remote CareLink data transmission

What is being measured

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

  1. Phase I: incidence of pre-specified clinical and arrhythmic events

    In patients with low ejection fraction that are hospitalized for acute cardiac decompensation, the pre-specified events include:

    1. Cardiovascular mortality or unplanned cardiovascular hospitalizations (including hospitalizations that will be scheduled due to pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization therapy device implant)
    2. Arrhythmic events

    Measured: implant to 6 months post-implant

  2. Phase II: incidence of pre-specified clinical and arrhythmic events

    In patients with low ejection fraction that are hospitalized for acute cardiac decompensation, the pre-specified events include:

    1. Cardiovascular mortality or unplanned cardiovascular hospitalizations (including hospitalizations that will be scheduled due to pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization therapy device implant)
    2. Arrhythmic events

    Measured: implant to 24 months post-implant

Secondary outcomes (2)

  1. Phase I: incidence of the pre-specified secondary clinical and arrhythmic events in patients implanted with the Reveal® XT

    Document the incidence of the pre-specified secondary clinical and arrhythmic events in patients implanted with the Reveal XT.

    The pre-specified secondary clinical and arrhythmic events are:

    • Time to first detection of brady-tachyarrhythmia episode;
    • All cause mortality or unplanned cardiovascular hospitalization;
    • Unplanned cardiovascular hospitalization;
    • Heart Failure hospitalization;
    • Cardiovascular mortality;
    • Serious cardiovascular Adverse Events.

    Measured: implant to 6 months post-implant

  2. Phase II: incidence of the pre-specified secondary clinical and arrhythmic events in patients implanted with the Reveal® XT

    Document the incidence of the pre-specified secondary clinical and arrhythmic events in patients implanted with the Reveal XT.

    The pre-specified secondary clinical and arrhythmic events are:

    • Time to first detection of brady-tachyarrhythmia episode;
    • All cause mortality or unplanned cardiovascular hospitalization;
    • Unplanned cardiovascular hospitalization;
    • Heart Failure hospitalization;
    • Cardiovascular mortality;
    • Serious cardiovascular Adverse Events

    Measured: implant to 24 months post-implant

Timeline

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

  1. First posted7 Oct 2010 (estimated)
  2. Study startFeb 2011
  3. Primary completionNov 2013
  4. Study completionMay 2014

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01216670
Sponsor's protocol ID
MDT-CARRYINGONforHF
Acronym
CARRYINGON
Status last verified
Feb 2013
First submitted
21 Apr 2010
Last updated
14 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

  • Fonarow GC; ADHERE Scientific Advisory Committee. The Acute Decompensated Heart Failure National Registry (ADHERE): opportunities to improve care of patients hospitalized with acute decompensated heart failure. Rev Cardiovasc Med. 2003;4 Suppl 7:S21-30.

    PubMed 14668697

  • Nieminen MS, Bohm M, Cowie MR, Drexler H, Filippatos GS, Jondeau G, Hasin Y, Lopez-Sendon J, Mebazaa A, Metra M, Rhodes A, Swedberg K, Priori SG, Garcia MA, Blanc JJ, Budaj A, Cowie MR, Dean V, Deckers J, Burgos EF, Lekakis J, Lindahl B, Mazzotta G, Morais J, Oto A, Smiseth OA, Garcia MA, Dickstein K, Albuquerque A, Conthe P, Crespo-Leiro M, Ferrari R, Follath F, Gavazzi A, Janssens U, Komajda M, Morais J, Moreno R, Singer M, Singh S, Tendera M, Thygesen K; ESC Committe for Practice Guideline (CPG). Executive summary of the guidelines on the diagnosis and treatment of acute heart failure: the Task Force on Acute Heart Failure of the European Society of Cardiology. Eur Heart J. 2005 Feb;26(4):384-416. doi: 10.1093/eurheartj/ehi044. Epub 2005 Jan 28. No abstract available.

    PubMed 15681577

  • Di Lenarda A, Scherillo M, Maggioni AP, Acquarone N, Ambrosio GB, Annicchiarico M, Bellis P, Bellotti P, De Maria R, Lavecchia R, Lucci D, Mathieu G, Opasich C, Porcu M, Tavazzi L, Cafiero M; TEMISTOCLE Investigators. Current presentation and management of heart failure in cardiology and internal medicine hospital units: a tale of two worlds--the TEMISTOCLE study. Am Heart J. 2003 Oct;146(4):E12. doi: 10.1016/S0002-8703(03)00315-6.

    PubMed 14564335

  • Tavazzi L, Maggioni AP, Lucci D, Cacciatore G, Ansalone G, Oliva F, Porcu M; Italian survey on Acute Heart Failure Investigators. Nationwide survey on acute heart failure in cardiology ward services in Italy. Eur Heart J. 2006 May;27(10):1207-15. doi: 10.1093/eurheartj/ehi845. Epub 2006 Apr 7.

    PubMed 16603579

  • O'Connor CM, Stough WG, Gallup DS, Hasselblad V, Gheorghiade M. Demographics, clinical characteristics, and outcomes of patients hospitalized for decompensated heart failure: observations from the IMPACT-HF registry. J Card Fail. 2005 Apr;11(3):200-5. doi: 10.1016/j.cardfail.2004.08.160.

    PubMed 15812748

  • Cleland JG, Swedberg K, Follath F, Komajda M, Cohen-Solal A, Aguilar JC, Dietz R, Gavazzi A, Hobbs R, Korewicki J, Madeira HC, Moiseyev VS, Preda I, van Gilst WH, Widimsky J, Freemantle N, Eastaugh J, Mason J; Study Group on Diagnosis of the Working Group on Heart Failure of the European Society of Cardiology. The EuroHeart Failure survey programme-- a survey on the quality of care among patients with heart failure in Europe. Part 1: patient characteristics and diagnosis. Eur Heart J. 2003 Mar;24(5):442-63. doi: 10.1016/s0195-668x(02)00823-0.

    PubMed 12633546

  • Fonarow GC, Stough WG, Abraham WT, Albert NM, Gheorghiade M, Greenberg BH, O'Connor CM, Sun JL, Yancy CW, Young JB; OPTIMIZE-HF Investigators and Hospitals. Characteristics, treatments, and outcomes of patients with preserved systolic function hospitalized for heart failure: a report from the OPTIMIZE-HF Registry. J Am Coll Cardiol. 2007 Aug 21;50(8):768-77. doi: 10.1016/j.jacc.2007.04.064. Epub 2007 Aug 6.

    PubMed 17707182

  • Braunschweig F. Therapeutic and diagnostic role of electrical devices in acute heart failure. Heart Fail Rev. 2007 Jun;12(2):157-66. doi: 10.1007/s10741-007-9019-0.

    PubMed 17447136

  • Vanoli E, Mortara A, Diotallevi P, Gallone G, Mariconti B, Gronda E, Gentili A, Bisetti S, Botto GL. Cardiac Rhythm Monitoring After Acute Decompensation for Heart Failure: Results from the CARRYING ON for HF Pilot Study. JMIR Res Protoc. 2016 Apr 26;5(2):e62. doi: 10.2196/resprot.4380.

    PubMed 27118481

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by Medtronic Italia at 4 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 8 inclusion and 9 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 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Phase I: incidence of pre-specified clinical and arrhythmic events (time frame: implant to 6 months post-implant). 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 NCT01216670, which also lists 9 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 14 Oct 2015.

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