"De Novo" Atrial Fibrillation in Patients With Heart Failure: Incidence; Predictors and Relevance.

NCT04755010 | Unknown FDA Device

• 1 other identifier: 2019/082
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Atrial fibrillation (AF) represents a problem of great implications to patients with heart failure (HF). Therefore, the risk of having AF increases up to 4,5 -5,9 times with the presence of HF. Both conditions share risk factors and the presence of the one worsens the progress of the other. Therefore, the AF is not only relevant in terms of thromboembolic events. Timing of AF progression seems to be associated with an increase in all causes of mortality. Although, it is estimated that between 30%-40% of the patients with HF develop AF, given that in many cases it occurs with no apparent symptoms for the patients, is considered that the number of affected patients is greater. Since silent AF poses a problem of great impact in patients with HF, monitoring through continuous electrocardiographic registry could be useful in those patients with a higher risk of thromboembolic events. The purpose of this study is to understand the mechanism and biological and clinical relevance of the AF from a holistic approach. Trying to distinguish the symptomatic AF from the silent one using the implementation of insertable cardiac devices. The purpose of this study is 1. To determine in which percentage of patients with HF, episodes of AF both symptomatic and asymptomatic occur, as well as if the presence of AF represents an irrelevant fact in the progression of the insufficiency or in the contrary, it is the cause of the HF patients clinical decline. 2. To examine the presence of triggers of AF in patients with HF and to identify the presence of clinical markers, image markers of the atrium and left ventricle, as well as biomarkers which allow the risk of stratification and could mean future therapeutic targets.

Conditions

Atrial Fibrillation; Heart Failure

Keywords

Implantable cardiac monitoring

Outcome Measures

Primary Outcomes (1)

• Incidence of AF

  Prevalence and predictor of atrial fibrillation in 300 patients with heart failure and without previous history of AF determined by the Reveal LINQ Insertable Cardiac Monitor

  3 years

Secondary Outcomes (1)

• Echocardiography

  3 years

Interventions

Linq II implantable cardiac monitor DEVICE

Implantation of Linq II implantable cardiac monitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

On the basis of previously reported data, we estimated that the annual rate of AF in patients 65 years of age or older who have CHA2DS2VASc ≥ 2 and who have received an ICM or a pacemaker would be approximately 6%. We then estimated that with enrolment of 300 patients, the study would have 95% power to detect an episode of rapid atrial rate

You may qualify if:

• Patients with the previous diagnosis of HF with both preserved and depressed LVEF. Patients with preserved or intermediate LVEF will be defined according to current guidelines.
• Patients with signs and symptoms of HFor b) LVEF between 40 and 49 for "mid range" and greater than or equal to 50 for those with LVEF preserved, high natriuretic peptides (BNP\> 35 pg / ml and / or NT-proBNP\> 125 pg / mL)and at least one of these two criteria: Relevant structural disease (left ventricular hypertrophy or dilatation left earphone).
• Diastolic dysfunction.

You may not qualify if:

• Previous history of atrial fibrillation.
• CHA2DS2VASc \< 2.
• Patients requiring ventricular pacing \> 40 patients
• Patients under cardiac resynchronization therapy pacemaker/devices.
• Patients with severe valvulopathy.
• Patients with reverseble

Sponsors & Collaborators

• Hospital Clinico Universitario de Santiago: lead
• University of Salamanca: collaborator
• Hospital Universitario Virgen de la Arrixaca: collaborator
• Hospital Universitario San Juan de Alicante: collaborator

Study Sites (1)

Moises Rodriguez Mañero

Santiago de Compostela, A Coruña, 15706, Spain

RECRUITING

Related Publications (5)

• January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; ACC/AHA Task Force Members. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation. 2014 Dec 2;130(23):e199-267. doi: 10.1161/CIR.0000000000000041. Epub 2014 Mar 28. No abstract available.

  PMID: 24682347 BACKGROUND

• Healey JS, Alings M, Ha A, Leong-Sit P, Birnie DH, de Graaf JJ, Freericks M, Verma A, Wang J, Leong D, Dokainish H, Philippon F, Barake W, McIntyre WF, Simek K, Hill MD, Mehta SR, Carlson M, Smeele F, Pandey AS, Connolly SJ; ASSERT-II Investigators. Subclinical Atrial Fibrillation in Older Patients. Circulation. 2017 Oct 3;136(14):1276-1283. doi: 10.1161/CIRCULATIONAHA.117.028845. Epub 2017 Aug 4.

  PMID: 28778946 BACKGROUND

• Reiffel JA, Verma A, Kowey PR, Halperin JL, Gersh BJ, Wachter R, Pouliot E, Ziegler PD; REVEAL AF Investigators. Incidence of Previously Undiagnosed Atrial Fibrillation Using Insertable Cardiac Monitors in a High-Risk Population: The REVEAL AF Study. JAMA Cardiol. 2017 Oct 1;2(10):1120-1127. doi: 10.1001/jamacardio.2017.3180.

  PMID: 28842973 BACKGROUND

• Piccini JP, Passman R, Turakhia M, Connolly AT, Nabutovsky Y, Varma N. Atrial fibrillation burden, progression, and the risk of death: a case-crossover analysis in patients with cardiac implantable electronic devices. Europace. 2019 Mar 1;21(3):404-413. doi: 10.1093/europace/euy222.

  PMID: 30462208 BACKGROUND

• DeCicco AE, Finkel JB, Greenspon AJ, Frisch DR. Clinical significance of atrial fibrillation detected by cardiac implantable electronic devices. Heart Rhythm. 2014 Apr;11(4):719-24. doi: 10.1016/j.hrthm.2014.01.001. Epub 2014 Jan 3.

  PMID: 24394157 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biological characterization Human plasma samples: Total venous blood samples (10 ml) will be collected in EDTA tubes as anticoagulant and separated by centrifugation at 1500xg during 15 minutes plasma and cellular fractions. The supernatant and the cell pellet are transferred to tubes and stored at -80°C. The serological samples will be stored in each center of origin. Several determinations will be performed:

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• moises rodriguez mañero, PhD

  Clínico Universitario de Santiago de Compostela

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Moises rodriguez mañero, PhD

CONTACT

616903275; moirmanero@gmail.com

Jose Ramón gonzalez-juanatey, PhD

CONTACT

616245508; Jose.Ramon.Gonzalez.Juanatey@sergas.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: February 15, 2021
• Study Start: October 1, 2019
• Primary Completion: October 1, 2023
• Study Completion: November 1, 2023
• Last Updated: February 15, 2021

Record last verified: 2021-02

Locations

ES (1)