Chronotropic Incompetence (CI) Diagnostic Algorithm in Heart Failure Patients

Not Applicable

Terminated

• Conditions: Heart Failure
• Interventions: Diagnostic Test: Chronotropic Incompetence Diagnostic Algorithm

• 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

Arm && Interventions

Group	Intervention	Description
Control group	Chronotropic Incompetence Diagnostic Algorithm	Each subject of the control group will do the same test and examination with the subjects in the case group.
Case group	Chronotropic Incompetence Diagnostic Algorithm	At the beginning of the study, each subject of the case group will complete echo examination and related lab test for BNP. During the study, each subject will have a six minutes' walk test and 24 hour ambulatory monitoring while having an ActiGraph device placed on his/her wrist and a Holter device with ECG electrodes placed on his/her chest. The treadmill test is optional to patients per physicians' instruction and/or patients' own judgment. It would be performed at the end of the study if chosen.

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)

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

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