Chronotropic Incompetence (CI) Diagnostic Algorithm in Heart Failure Patients

Medtronic

Status: Terminated

Conditions: Heart Failure

Treatments: Diagnostic Test: Chronotropic Incompetence Diagnostic Algorithm

Study type: Interventional

Funder types: Industry

Identifiers

NCT02358603

CI in Heart Failure Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups, including a placebo group

Case group

Experimental group

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.

Treatment:

Diagnostic Test: Chronotropic Incompetence Diagnostic Algorithm

Control group

Placebo Comparator group

Description:

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

Treatment:

Diagnostic Test: Chronotropic Incompetence Diagnostic Algorithm