Phase
Condition
Chest Pain
Heart Failure
Arrhythmia
Treatment
Placebo
JK07
Clinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants with New York Heart Association (NYHA) Class II-III.
Cohort 1 - Left Ventricular Ejection Fraction (LVEF) ≤ 40%.
Cohort 2 - Left Ventricular Ejection Fraction (LVEF) >40% and ≤ 65%, elevatedN-terminal pro B-type natriuretic peptide (NT-proBNP) ≥ 600pg/mL and atrialfibrillation/flutter.
Stable heart failure and on optimal medical therapy.
Screening hemoglobin ≥ 9.0 g/dL.
Exclusion
Exclusion Criteria:
Uncontrolled hypertension.
Sustained systolic Blood Pressure (BP) < 90 mmHg and/or diastolic BP < 50 mmHg on 2consecutive (duplicate seated) readings at screening.
Heart failure due to hypertrophic cardiomyopathy, restrictive and/or infiltrativecardiomyopathy, arrhythmogenic right ventricular dysplasia, Fabry disease, or Noonansyndrome with LV hypertrophy or a positive serum immunofixation result.
Diagnosis of stress-induced (Takotsubo) cardiomyopathy, myocarditis, or peripartumcardiomyopathy.
Diagnosis of chemotherapy- or radiation-induced cardiomyopathy.
Diagnosed with stroke or Transient Ischemic Attack (TIA) within 12 weeks ofscreening.
History of syncope within the last 12 weeks prior to screening or sustainedventricular tachycardia without an implantable cardioverter-defibrillator.
Moderate or severe aortic and/or mitral valve stenosis.
Medically documented unstable angina, acute coronary syndrome (e.g., myocardialinfarction, troponin-positive with symptoms of angina or unstable angina) within thelast 8 weeks prior to start of screening.
Medically documented ST-elevation myocardial infarction within 12 weeks ofscreening.
Any tachycardia (inclusive of Atrial Fibrillation (AF) or atrial flutter) with aresting ventricular rate > 110 beats per minute at screening.
For participants with a history of AF or atrial flutter, not on adequateanticoagulant therapy via non-vitamin K oral anticoagulants or warfarin if theCHA2DS2-VASc score is ≥ 2 in men or ≥ 3 in women or per local guidelines.Percutaneous occlusion of the left atrial appendage alone is not adequate.
AF ablation within the last 12 weeks prior to screening or planned during the studyduration.
Symptomatic bradycardia or second (Mobitz Type II)- or third-degree heart blockwithout a pacemaker.
Cardiac surgery, coronary artery revascularization or indication for coronary arteryrevascularization, percutaneous coronary intervention, valve repair/replacement orvalvuloplasty within 12 weeks prior to screening.
Implantation of a Cardiac Resynchronization Therapy (CRT) device within 12 weeksprior to screening, or intent to implant a CRT device during the course of thestudy.
Previous cardiac transplantation, or any use of mechanical circulatory support orsimilar device, or implantation expected after randomization.
Receiving mechanical hemodynamic support or invasive mechanical ventilation withinthe last 8 weeks prior to screening.
Receiving Intravenous (IV) inotropes or IV vasopressors within the last 8 weeksprior to screening.
Receiving IV vasodilators within the last 4 weeks prior to screening.
Receiving noninvasive mechanical ventilation within the last 4 weeks prior toscreening. The use of noninvasive ventilation for sleep disordered breathing ispermitted.
Study Design
Connect with a study center
Site 202
Winnepeg, Manitoba 6065171 R2H2A6
CanadaActive - Recruiting
Site 203
Brampton, Ontario L6Z 4N5
CanadaSite Not Available
Site 203
Brampton 5907364, Ontario 6093943 L6Z 4N5
CanadaActive - Recruiting
Ecogene-21
Chicoutimi, Quebec G7H 7K9
CanadaActive - Recruiting
Site 200
Chicoutimi, Quebec G7H 7K9
CanadaSite Not Available
Site 201
Trois-Rivieres, Quebec G9A 4P3
CanadaSite Not Available
Site 200
Chicoutimi 5921225, Quebec 6115047 G7H 7K9
CanadaActive - Recruiting
Site 201
Trois-Rivières 6169141, Quebec 6115047 G9A 4P3
CanadaActive - Recruiting
Site 305
Changsha, Hunan 410005
ChinaSite Not Available
Site 305
Changsha 1815577, Hunan 1806691 410005
ChinaActive - Recruiting
Site 303
Nanjing, Jiangsu 210009
ChinaSite Not Available
Site 303
Nanjing 1799962, Jiangsu 1806260 210009
ChinaActive - Recruiting
Site 306
Jining, Shandong 272100
ChinaSite Not Available
Site 306
Jining 1805518, Shandong 1796328 272100
ChinaActive - Recruiting
Site 301
Chengdu, Sichuan 610041
ChinaSite Not Available
Site 301
Chengdu 1815286, Sichuan 1794299 610041
ChinaActive - Recruiting
Site 300
Beijing, 100037
ChinaSite Not Available
Site 300
Beijing 1816670, 100037
ChinaActive - Recruiting
Site 304
Chongqing, 404000
ChinaSite Not Available
Site 304
Chongqing 1814906, 404000
ChinaActive - Recruiting
Site 156
Ponce, 00717
Puerto RicoSite Not Available
Site 156
Ponce 4566880, 00717
Puerto RicoActive - Recruiting
Advanced Cardiovascular LLC
Alexander City, Alabama 35010
United StatesActive - Recruiting
Site 121
Alexander City, Alabama 35010
United StatesSite Not Available
Site 130
Birmingham, Alabama 35211
United StatesActive - Recruiting
Site 139
Birmingham, Alabama 35294
United StatesSite Not Available
Site 138
Huntsville, Alabama 35801
United StatesSite Not Available
Site 121
Alexander City 4829843, Alabama 4829764 35010
United StatesActive - Recruiting
Site 130
Birmingham 4049979, Alabama 4829764 35211
United StatesActive - Recruiting
Site 139
Birmingham 4049979, Alabama 4829764 35294
United StatesActive - Recruiting
Site 138
Huntsville 4068590, Alabama 4829764 35801
United StatesActive - Recruiting
Arizona Arrhythmia Research Center
Phoenix, Arizona 85016
United StatesActive - Recruiting
Site 111
Phoenix, Arizona 85016
United StatesSite Not Available
Site 111
Phoenix 5308655, Arizona 5551752 85016
United StatesActive - Recruiting
Site 127
Little Rock, Arkansas 72205
United StatesSite Not Available
Site 127
Little Rock 4119403, Arkansas 4099753 72205
United StatesActive - Recruiting
National Institute of Clinical Research
Huntington Beach, California 92648
United StatesActive - Recruiting
Site 128
Huntington Beach, California 92648
United StatesSite Not Available
Site 157
Los Angeles, California 90033
United StatesSite Not Available
Site 158
Orange, California 92868
United StatesSite Not Available
Site 116
Pasadena, California 91105
United StatesSite Not Available
Southern California Heart Specialists
Pasadena, California 91105
United StatesActive - Recruiting
FOMAT Medical Research
Santa Maria, California 93454
United StatesActive - Recruiting
Site 129
Santa Maria, California 93454
United StatesSite Not Available
Site 102
Stanford, California 94305
United StatesSite Not Available
Site 113
Torrance, California 90502
United StatesSite Not Available
Blue Coast Research Center, LLC
Vista, California 92081
United StatesActive - Recruiting
Site 133
Vista, California 92081
United StatesSite Not Available
Site 128
Huntington Beach 5358705, California 5332921 92648
United StatesActive - Recruiting
Site 157
Los Angeles 5368361, California 5332921 90033
United StatesActive - Recruiting
Site 158
Orange 5379513, California 5332921 92868
United StatesActive - Recruiting
Site 116
Pasadena 5381396, California 5332921 91105
United StatesActive - Recruiting
Site 129
Santa Maria 5393180, California 5332921 93454
United StatesActive - Recruiting
Site 102
Stanford 5398563, California 5332921 94305
United StatesActive - Recruiting
Site 113
Torrance 5403022, California 5332921 90502
United StatesActive - Recruiting
Site 133
Vista 5406602, California 5332921 92081
United StatesActive - Recruiting
Site 161
Coral Gables, Florida 33134
United StatesSite Not Available
New Generation of Medical Research
Hialeah, Florida 33016
United StatesActive - Recruiting
Site 114
Hialeah, Florida 33016
United StatesSite Not Available
Site 162
Miami Lakes, Florida 33014
United StatesSite Not Available
Site 159
Naples, Florida 34104
United StatesSite Not Available
Site 161
Coral Gables 4151871, Florida 4155751 33134
United StatesActive - Recruiting
Site 114
Hialeah 4158476, Florida 4155751 33016
United StatesActive - Recruiting
Site 162
Miami Lakes 4164186, Florida 4155751 33014
United StatesActive - Recruiting
Site 159
Naples 4165565, Florida 4155751 34104
United StatesActive - Recruiting
Accel Research Sites
Atlanta, Georgia 30343
United StatesActive - Recruiting
Site 136
Atlanta, Georgia 30343
United StatesSite Not Available
Site 136
Atlanta 4180439, Georgia 4197000 30343
United StatesActive - Recruiting
Site 143
Boise, Idaho 83712
United StatesSite Not Available
Site 143
Boise 5586437, Idaho 5596512 83712
United StatesActive - Recruiting
Site 160
Chicago, Illinois 60611
United StatesSite Not Available
Site 154
Park Ridge, Illinois 60068
United StatesSite Not Available
Site 160
Chicago 4887398, Illinois 4896861 60611
United StatesActive - Recruiting
Site 154
Park Ridge 4905367, Illinois 4896861 60068
United StatesActive - Recruiting
Nexgen Research
Fort Wayne, Indiana 46804
United StatesActive - Recruiting
Site 137
Fort Wayne, Indiana 46804
United StatesSite Not Available
Community Health Network
Indianapolis, Indiana 46250
United StatesActive - Recruiting
Site 112
Indianapolis, Indiana 46250
United StatesSite Not Available
Site 137
Fort Wayne 4920423, Indiana 4921868 46804
United StatesActive - Recruiting
Site 112
Indianapolis 4259418, Indiana 4921868 46250
United StatesActive - Recruiting
Louisiana Heart Center
Covington, Louisiana 70433
United StatesActive - Recruiting
Site 104
Covington, Louisiana 70433
United StatesSite Not Available
Site 104
Covington 4321005, Louisiana 4331987 70433
United StatesActive - Recruiting
Site 118
Baltimore, Maryland 21201
United StatesSite Not Available
Site 118
Baltimore 4347778, Maryland 4361885 21201
United StatesActive - Recruiting
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
Site 119
Boston, Massachusetts 02114
United StatesSite Not Available
Site 119
Boston 4930956, Massachusetts 6254926 02114
United StatesActive - Recruiting
Cardiology and Vascular Associates
Bloomfield Hills, Michigan 48304
United StatesActive - Recruiting
Profound Research LLC/Cardiology and Vascular Associates - CAVA
Bloomfield Hills, Michigan 48304
United StatesActive - Recruiting
Site 122
Bloomfield Hills, Michigan 48304
United StatesSite Not Available
Pulse Cardiology
Farmington Hills, Michigan 48334
United StatesActive - Recruiting
Site 150
Farmington Hills, Michigan 48334
United StatesSite Not Available
Site 122
Bloomfield Hills 4986429, Michigan 5001836 48304
United StatesActive - Recruiting
Site 150
Farmington Hills 4992523, Michigan 5001836 48334
United StatesActive - Recruiting
Site 107
Rochester, Minnesota 55905
United StatesSite Not Available
Site 107
Rochester 5043473, Minnesota 5037779 55905
United StatesActive - Recruiting
Site 105
Saint Louis, Missouri 63136
United StatesSite Not Available
Site 106
Saint Louis, Missouri 63110
United StatesActive - Recruiting
St. Louis Heart and Vascular Cardiology
Saint Louis, Missouri 63136
United StatesActive - Recruiting
Washington University School of Medicine in St. Louis
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Site 105
St Louis 4407066, Missouri 4398678 63136
United StatesActive - Recruiting
Site 106
St Louis 4407066, Missouri 4398678 63110
United StatesActive - Recruiting
Ash Research Clinic
Brick, New Jersey 08724
United StatesActive - Recruiting
Site 144
Brick, New Jersey 08724
United StatesSite Not Available
Site 144
Brick 5095947, New Jersey 5101760 08724
United StatesActive - Recruiting
Site 153
Valhalla, New York 10595
United StatesSite Not Available
Site 153
Valhalla 5142090, New York 5128638 10595
United StatesActive - Recruiting
Site 152
Asheville, North Carolina 28803
United StatesSite Not Available
Cary Research Group, LLC
Cary, North Carolina 27518
United StatesActive - Recruiting
Site 109
Cary, North Carolina 27518
United StatesSite Not Available
Site 140
Charlotte, North Carolina 28204
United StatesSite Not Available
Site 145
Durham, North Carolina 27710
United StatesSite Not Available
Site 152
Asheville 4453066, North Carolina 4482348 28803
United StatesActive - Recruiting
Site 109
Cary 4459467, North Carolina 4482348 27518
United StatesActive - Recruiting
Site 140
Charlotte 4460243, North Carolina 4482348 28204
United StatesActive - Recruiting
Site 145
Durham 4464368, North Carolina 4482348 27710
United StatesActive - Recruiting
Site 117
Cincinnati, Ohio 45219
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195
United StatesActive - Recruiting
Site 100
Cleveland, Ohio 44195
United StatesSite Not Available
Site 117
Cincinnati 4508722, Ohio 5165418 45219
United StatesActive - Recruiting
Site 100
Cleveland 5150529, Ohio 5165418 44195
United StatesActive - Recruiting
Site 135
Oklahoma City, Oklahoma 73135
United StatesSite Not Available
Site 135
Oklahoma City 4544349, Oklahoma 4544379 73135
United StatesActive - Recruiting
Site 101
Portland, Oregon 97239
United StatesSite Not Available
Site 101
Portland 5746545, Oregon 5744337 97239
United StatesActive - Recruiting
Site 155
York, Pennsylvania 17403
United StatesSite Not Available
Site 155
York 4562407, Pennsylvania 6254927 17403
United StatesActive - Recruiting
Site 110
Dallas, Texas 75235
United StatesSite Not Available
Site 115
Dallas, Texas 75246
United StatesActive - Recruiting
Southwest Family Medicine
Dallas, Texas 75235
United StatesActive - Recruiting
Site 103
Houston, Texas 77030
United StatesSite Not Available
LinQ Research, LLC
Tomball, Texas 77375
United StatesActive - Recruiting
Site 149
Tomball, Texas 77375
United StatesSite Not Available
Site 110
Dallas 4684888, Texas 4736286 75235
United StatesActive - Recruiting
Site 115
Dallas 4684888, Texas 4736286 75246
United StatesActive - Recruiting
Site 103
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting
Site 149
Tomball 4737094, Texas 4736286 77375
United StatesActive - Recruiting
Site 148
Arlington, Virginia 22205
United StatesSite Not Available
Site 123
Falls Church, Virginia 22042
United StatesSite Not Available
Site 126
Norfolk, Virginia 23507
United StatesSite Not Available
Site 163
Vienna, Virginia 22182
United StatesSite Not Available
Site 148
Arlington 4744709, Virginia 6254928 22205
United StatesActive - Recruiting
Site 123
Falls Church 4758390, Virginia 6254928 22042
United StatesActive - Recruiting
Site 126
Norfolk 4776222, Virginia 6254928 23507
United StatesActive - Recruiting
Site 163
Vienna 4791160, Virginia 6254928 22182
United StatesActive - Recruiting

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