Chronotropic Incompetence (CI) Diagnostic Algorithm in Heart Failure Patients

Not Applicable

Terminated

• Conditions: Heart Failure

• Registration Number: NCT02358603
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Brief Summary

This study is to collect human activity and electrocardiogram (ECG) data from heart failure (HF) patients to aid in the development of a novel chronotropic incompetence (CI) algorithm designed to diagnose CI in patients with HF.

Detailed Description

The Investigation of the Chronotropic Incompetence Diagnostic Algorithm in Heart Failure Patients (CI Algorithm Study) is an acute data collection study using market released actigraphy devices (wGT3X-BT) and holter devices (DR 180) to measure study subjects' daily activities and surface ECG data simultaneously. The data will be analyzed to develop an algorithm to diagnose CI in patients with HF.

Study Timeline

• Study First Submitted: 2014-05-16
• Study Start: 2014-06
• Study First Submitted QC: 2015-02-03
• Study First Posted: 2015-02-09
• Primary Completion: 2015-06
• Study Completion: 2015-12
• Results First Submitted: 2017-04-25
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-23
• Last Update Submitted: 2020-01-23
• Results First Posted: 2020-02-05
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Chronotropic Incompetence Index of Patients With Heart Failure Disease	Implant through 6 months	Compare chronotropic incompetence index in patients with heart failure using an interventional diagnostic algorithm compared to standard of care diagnostics.; Chronotropic Index = \[achieved maximal HR-resting HR\]/\[age-predicted maximal HR-resting HR\]. Normal CI is \~ 1 with low CI considered \< 0.8; Measurement described as: Chronotropic index=HRR/metabolic reserve.

Trial Locations

Locations (2)

Ruijin Hospital Luwan Branch, Shanghai JiaoTong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China

Sixth People's Hospital Affiliated to Shanghai Jiaotong University; 🇨🇳 Shanghai, Shanghai, China