Graz Study on the Risk of Atrial Fibrillation

Hypertension Clinical Trial

— GRAF  

Official title:

Randomized Controlled Trial to Evaluate Implanted Event Recorders for the First Diagnosis of Atrial Fibrillation in High-risk Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01461434
• Other study ID #: GRAF-01-SCCT
• Status: Active, not recruiting
• Phase: Phase 4
• First received: October 23, 2011
• Last updated: December 20, 2015
• Start date: November 2011
• Est. completion date: January 2016

Study information

• Verified date: December 2015
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial Summary

Atrial fibrillation (AF) is the most common clinical arrhythmia. AF is associated with increased risk for stroke due to blood clots formed in the fibrillating atria. Some patient characteristics increase the likelyhood of AF and at the same time the risk of stroke when AF has developed. To reduce the risk of stroke, anticoagulation therapy is recommended in patients with AF and risk factors (such as high blood pressure, diabetes, vessel disease). However, occasional (paroxysmal) AF may occur without symptoms and remain undetected, leaving patients at risk.

Aim of the prospective randomized study is to compare two management strategies for patients at increased risk for AF but without a known history of AF. Patients are seen regularly (monthly, then quarterly) for follow-up (incl. ECG recording and blood sample). One group of patients additionally receives a subcutaneous implantation of a loop recorder for continuous rhythm monitoring, while the control group remains on standard follow-up. Observation period is one year (optional extension for 3 years). The time to first diagnosis of AF is compared between groups, blood samples are analyzed for potential biomarkers of AF.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 82
• Est. completion date: January 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• CHA2DS2-VASc risk score >= 4*

• 18 years or older

Exclusion Criteria:

• known history of atrial fibrillation

• implanted rhythm device

• pre-existing indication for oral anticoagulation

(*)CHA2DS2-VASc: C - chronic heart failure (1 point); H - hypertension (1 point); A - age >= 75 years (2 points); D - diabetes (1 point); S - stroke (2 points); V - vascular disease (1 point); A - age >=65 and < 75 years (1 point); Sc - sex category (female) (1 point) ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Atrial Fibrillation
• Chronic Heart Failure
• Diabetes
• Hypertension
• Vascular Disease
• Vascular Diseases

Intervention

Device:
• Medtronic Reveal XT implantable loop recorder
subcutaneous implantation

Locations

Country	Name	City	State
Austria	LKH/Uniklinikum - Klinische Abteilung für Kardiologie	Graz

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Graz	Medtronic

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first diagnosis of atrial fibrillation		12 months	No
Secondary	Time to change in therapy based on the diagnosis of atrial fibrillation		Baseline (0 months), 1,2,3,4,5,6,9 and 12 months	No
Secondary	Hospitalizations		12 months	No
Secondary	Change in NTproBNP serum level associated with occurrence of atrial fibrillation		Baseline (0 months), 1,2,3,4,5,6,9 and 12 months	No
Secondary	Death		12 months	No
Secondary	Stroke		12 months	No