Phase
Condition
Congestive Heart Failure
Hyponatremia
Heart Failure
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 R2H2A6
CanadaActive - Recruiting
Site 203
Brampton, Ontario L6Z 4N5
CanadaActive - Recruiting
Ecogene-21
Chicoutimi, Quebec G7H 7K9
CanadaActive - Recruiting
Site 200
Chicoutimi, Quebec G7H 7K9
CanadaActive - Recruiting
Site 201
Trois-Rivieres, Quebec G9A 4P3
CanadaActive - Recruiting
Site 305
Changsha, Hunan 410005
ChinaActive - Recruiting
Site 303
Nanjing, Jiangsu 210009
ChinaActive - Recruiting
Site 306
Jining, Shandong 272100
ChinaActive - Recruiting
Site 301
Chengdu, Sichuan 610041
ChinaActive - Recruiting
Site 300
Beijing, 100037
ChinaActive - Recruiting
Site 304
Chongqing, 404000
ChinaActive - Recruiting
Site 156
Ponce, 00717
Puerto RicoActive - Recruiting
Advanced Cardiovascular LLC
Alexander City, Alabama 35010
United StatesActive - Recruiting
Site 121
Alexander City, Alabama 35010
United StatesActive - Recruiting
Site 130
Birmingham, Alabama 35211
United StatesActive - Recruiting
Site 139
Birmingham, Alabama 35294
United StatesActive - Recruiting
Site 138
Huntsville, Alabama 35801
United StatesActive - Recruiting
Arizona Arrhythmia Research Center
Phoenix, Arizona 85016
United StatesActive - Recruiting
Site 111
Phoenix, Arizona 85016
United StatesActive - Recruiting
Site 127
Little Rock, Arkansas 72205
United StatesActive - Recruiting
National Institute of Clinical Research
Huntington Beach, California 92648
United StatesActive - Recruiting
Site 128
Huntington Beach, California 92648
United StatesActive - Recruiting
Site 158
Orange, California 92868
United StatesActive - Recruiting
Site 116
Pasadena, California 91105
United StatesActive - Recruiting
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 StatesActive - Recruiting
Site 102
Stanford, California 94305
United StatesActive - Recruiting
Site 113
Torrance, California 90502
United StatesActive - Recruiting
Blue Coast Research Center, LLC
Vista, California 92081
United StatesActive - Recruiting
Site 133
Vista, California 92081
United StatesActive - Recruiting
New Generation of Medical Research
Hialeah, Florida 33016
United StatesActive - Recruiting
Site 114
Hialeah, Florida 33016
United StatesActive - Recruiting
Site 159
Naples, Florida 34104
United StatesActive - Recruiting
Accel Research Sites
Atlanta, Georgia 30343
United StatesActive - Recruiting
Site 136
Atlanta, Georgia 30343
United StatesActive - Recruiting
Site 143
Boise, Idaho 83712
United StatesActive - Recruiting
Site 160
Chicago, Illinois 60611
United StatesActive - Recruiting
Site 154
Park Ridge, Illinois 60068
United StatesActive - Recruiting
Nexgen Research
Fort Wayne, Indiana 46804
United StatesActive - Recruiting
Site 137
Fort Wayne, Indiana 46804
United StatesActive - Recruiting
Community Health Network
Indianapolis, Indiana 46250
United StatesActive - Recruiting
Site 112
Indianapolis, Indiana 46250
United StatesActive - Recruiting
Louisiana Heart Center
Covington, Louisiana 70433
United StatesActive - Recruiting
Site 104
Covington, Louisiana 70433
United StatesActive - Recruiting
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
Site 119
Boston, Massachusetts 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 StatesActive - Recruiting
Pulse Cardiology
Farmington Hills, Michigan 48334
United StatesActive - Recruiting
Site 150
Farmington Hills, Michigan 48334
United StatesActive - Recruiting
Site 107
Rochester, Minnesota 55905
United StatesActive - Recruiting
Site 105
Saint Louis, Missouri 63136
United StatesActive - Recruiting
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
Ash Research Clinic
Brick, New Jersey 08724
United StatesActive - Recruiting
Site 144
Brick, New Jersey 08724
United StatesActive - Recruiting
Site 153
Valhalla, New York 10595
United StatesActive - Recruiting
Site 152
Asheville, North Carolina 28803
United StatesActive - Recruiting
Cary Research Group, LLC
Cary, North Carolina 27518
United StatesActive - Recruiting
Site 109
Cary, North Carolina 27518
United StatesActive - Recruiting
Site 140
Charlotte, North Carolina 28204
United StatesActive - Recruiting
Site 117
Cincinnati, Ohio 45219
United StatesActive - Recruiting
Cleveland Clinic
Cleveland, Ohio 44195
United StatesActive - Recruiting
Site 100
Cleveland, Ohio 44195
United StatesActive - Recruiting
Site 135
Oklahoma City, Oklahoma 73135
United StatesActive - Recruiting
Site 155
York, Pennsylvania 17403
United StatesActive - Recruiting
Site 110
Dallas, Texas 75235
United StatesActive - Recruiting
Site 115
Dallas, Texas 75246
United StatesActive - Recruiting
Southwest Family Medicine
Dallas, Texas 75235
United StatesActive - Recruiting
Site 103
Houston, Texas 77030
United StatesActive - Recruiting
LinQ Research, LLC
Tomball, Texas 77375
United StatesActive - Recruiting
Site 149
Tomball, Texas 77375
United StatesActive - Recruiting
Site 148
Arlington, Virginia 22205
United StatesActive - Recruiting
Site 123
Falls Church, Virginia 22042
United StatesActive - Recruiting
Site 126
Norfolk, Virginia 23507
United StatesActive - Recruiting
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