Chronotropic Incompetence (CI) Diagnostic Algorithm in Heart Failure Patients

Investigation of the Chronotropic Incompetence Diagnostic Algorithm in Heart Failure Patients

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.

Study Overview

• Status: Terminated
• Conditions: Heart Failure
• Intervention / Treatment: Diagnostic test: Chronotropic Incompetence Diagnostic Algorithm

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200020
      • Ruijin Hospital Luwan Branch, Shanghai JiaoTong University School of Medicine
    • Shanghai, Shanghai, China, 200233
      • Sixth people's Hospital Affiliated to Shanghai Jiaotong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria for the case group:

• Patient is greater than 18 years of age and less than 70 years of old.
• Patient is willing and able to give informed consent.
• Patient has been diagnosed with stable chronic HF according to European Society of Cardiology 2012 HF guidance.
• New York Heart Association class I- III, including with HF with preserved ejection fraction and HF with reduced ejection fraction patients.
• Patients can perform moderate exercise.
• Left ventricular ejection fraction less than 55% but greater than 35%.

Inclusion criteria for the control group:

• Subject is greater than 18 years of age and less than 70 years of old.
• Subject is willing and able to give informed consent.

Exclusion criteria for the case group:

• Patient is unable or unwilling to sign the patient informed consent.
• Patient has implantable pacemaker, Implantable cardiovert defibrillator (ICD) or cardiac resynchronize therapy (CRT) device.
• Patient has at least one pacemaker, ICD or CRT indications.
• Patients has persistent atrial fibrillation (AF).
• Patient whose hear rate baseline at the rest is greater than 95 beats per minutes (BPM).
• Patient has contraindications for cardio-pulmonary exercise testing, including but not limited to, unstable angina, decompensated heart failure, active pericarditis or myocarditis and ECG ST-segment shift > 2mm at the resting.
• New York Heart Association Class IV.
• Less than 45 days after myocardial infarction.
• Less than 3 months after acute heart failure.
• Patient has uncontrolled hypertension.
• Patient is pregnant.
• Patient has a medical condition that would limit study participation.
• Patient is enrolled in a concurrent study that may affect the outcome of this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Case group; 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.	Diagnostic test: Chronotropic Incompetence Diagnostic Algorithm; Other Names: Standard of Care Diagnostic Testing
Placebo Comparator: Control group; Each subject of the control group will do the same test and examination with the subjects in the case group.	Diagnostic test: Chronotropic Incompetence Diagnostic Algorithm; Other Names: Standard of Care Diagnostic Testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronotropic Incompetence Index of Patients With Heart Failure Disease	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.	Implant through 6 months

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: Principal Investigator: Jianrong Zhao, MD, Ruijin Hospital Luwan Branch, Shanghai JiaoTong University School of Medicine; Principal Investigator: Jinbo Li, MD, Sixth people's Hospital Affiliated to Shanghai Jiaotong University

Publications and helpful links

General Publications

• Shen H, Zhao J, Zhou X, Li J, Wan Q, Huang J, Li H, Wu L, Yang S, Wang P. Impaired chronotropic response to physical activities in heart failure patients. BMC Cardiovasc Disord. 2017 May 25;17(1):136. doi: 10.1186/s12872-017-0571-9.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: May 16, 2014
• First Submitted That Met QC Criteria: February 3, 2015
• First Posted (Estimate): February 9, 2015

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 23, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Heart Failure; Chronotropic Incompetence
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CI in Heart Failure Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No