Chronotropic Incompetence (CI) Diagnostic Algorithm in Heart Failure Patients

NCT ID: NCT02358603

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-12-31

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Chronotropic Incompetence Diagnostic Algorithm

Intervention Type: DIAGNOSTIC_TEST

Control group

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

Group Type: PLACEBO_COMPARATOR

Chronotropic Incompetence Diagnostic Algorithm

Intervention Type: DIAGNOSTIC_TEST

Interventions

Chronotropic Incompetence Diagnostic Algorithm

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Standard of Care Diagnostic Testing

Eligibility Criteria

Inclusion Criteria

• 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%.

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianrong Zhao, MD

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital Luwan Branch, Shanghai JiaoTong University School of Medicine

Jinbo Li, MD

Role: PRINCIPAL_INVESTIGATOR

Sixth People's Hospital Affiliated to Shanghai Jiaotong University

Locations

Ruijin Hospital Luwan Branch, Shanghai JiaoTong University School of Medicine

Shanghai, Shanghai Municipality, China

Sixth People's Hospital Affiliated to Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 28545575 (View on PubMed)

Other Identifiers

CI in Heart Failure Study

Identifier Type: -

Identifier Source: org_study_id