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Chronotropic Incompetence (CI) Diagnostic Algorithm in Heart Failure Patients

Primary Purpose

Heart Failure

Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Chronotropic Incompetence Diagnostic Algorithm
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure focused on measuring Chronotropic Incompetence, Heart Failure

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ruijin Hospital Luwan Branch, Shanghai JiaoTong University School of Medicine
  • Sixth People's Hospital Affiliated to Shanghai Jiaotong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Case group

Control group

Arm Description

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.

Each subject of the control group will do the same test and examination with the subjects in the case group.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 16, 2014
Last Updated
January 23, 2020
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT02358603
Brief Title
Chronotropic Incompetence (CI) Diagnostic Algorithm in Heart Failure Patients
Official Title
Investigation of the Chronotropic Incompetence Diagnostic Algorithm in Heart Failure Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
Low recruitment rate
Study Start Date
June 2014 (Actual)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Chronotropic Incompetence, Heart Failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Case group subjects will complete study required protocol testing while wearing an experimental device, the ActiGraph device placed on his/her wrist and a Holter device with ECG electrodes placed on his/her chest. Results will be compared to a Control Group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Case group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Each subject of the control group will do the same test and examination with the subjects in the case group.
Intervention Type
Diagnostic Test
Intervention Name(s)
Chronotropic Incompetence Diagnostic Algorithm
Other Intervention Name(s)
Standard of Care Diagnostic Testing
Primary Outcome Measure Information:
Title
Chronotropic Incompetence Index of Patients With Heart Failure Disease
Description
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.
Time Frame
Implant through 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianrong Zhao, MD
Organizational Affiliation
Ruijin Hospital Luwan Branch, Shanghai JiaoTong University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jinbo Li, MD
Organizational Affiliation
Sixth People's Hospital Affiliated to Shanghai Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruijin Hospital Luwan Branch, Shanghai JiaoTong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200020
Country
China
Facility Name
Sixth People's Hospital Affiliated to Shanghai Jiaotong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200233
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28545575
Citation
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.
Results Reference
derived

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Chronotropic Incompetence (CI) Diagnostic Algorithm in Heart Failure Patients

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