Cardiac Rhythm Monitoring After Acute Decompensation for Heart Failure

Heart Failure Clinical Trial

— CARRYINGON  

Official title:

Cardiac Rhythm Monitoring After Acute Decompensation for Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01216670
• Other study ID #: MDT-CARRYINGONforHF
• Status: Completed
• Phase: Phase 4
• First received: April 21, 2010
• Last updated: October 12, 2015
• Start date: February 2011
• Est. completion date: May 2014

Study information

• Verified date: February 2013
• Source: Medtronic Italia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: Ministry of Health
• Study type: Observational

Clinical 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) that are hospitalized for acute cardiac decompensation.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Cognitive disease

• Pregnancy or childbearing potential and not on reliable contraceptive

• Anticipated compliance problem or participation in another competitive trial

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure

Intervention

Behavioral:
• remote patient's management
scheduled remote CareLink data transmission

Locations

Country	Name	City	State
Italy	A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria	Alessandria
Italy	A.O. Ospedale S. Anna di Como	Como
Italy	Policlinico di Monza	Monza
Italy	Clinica San Gaudenzio	Novara

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Italia

Country where clinical trial is conducted

Italy, 

References & Publications (8)

Braunschweig F. Therapeutic and diagnostic role of electrical devices in acute heart failure. Heart Fail Rev. 2007 Jun;12(2):157-66. Review. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2007 Aug 6. — View Citation

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. Review. — View Citation

Nieminen MS, Böhm 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. Epub 2005 Jan 28. — View Citation

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. — View Citation

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. Epub 2006 Apr 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: Cardiovascular mortality or unplanned cardiovascular hospitalizations (including hospitalizations that will be scheduled due to pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization therapy device implant); Arrhythmic events	implant to 6 months post-implant	No
Primary	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: Cardiovascular mortality or unplanned cardiovascular hospitalizations (including hospitalizations that will be scheduled due to pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization therapy device implant); Arrhythmic events	implant to 24 months post-implant	No
Secondary	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.	implant to 6 months post-implant	No
Secondary	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	implant to 24 months post-implant	No