Actively Recruiting
Study of JK07 in Patients With Chronic Heart Failure
Led by Salubris Biotherapeutics Inc · Updated on 2025-08-22
282
Participants Needed
62
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 2, randomized, double-blind, placebo-controlled, multiple dose study to assess the safety, tolerability, and efficacy of JK07 in participants aged 18-85 with heart failure. There will be 2 cohorts in this study: Cohort 1: Heart failure (HF) participants with left ventricular ejection fraction (LVEF) of ≤ 40%. Cohort 2: Heart failure (HF) participants with left ventricular ejection fraction (LVEF) \> 40% and ≤ 65%.
CONDITIONS
Official Title
Study of JK07 in Patients With Chronic Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with New York Heart Association (NYHA) Class II-III.
- Cohort 1: Left Ventricular Ejection Fraction (LVEF) 64 40%.
- Cohort 2: Left Ventricular Ejection Fraction (LVEF) >40% and 64 65%, elevated N-terminal pro B-type natriuretic peptide (NT-proBNP) 65 600pg/mL and atrial fibrillation/flutter.
- Stable heart failure and on optimal medical therapy.
- Screening hemoglobin 64 9.0 g/dL.
You will not qualify if you...
- Uncontrolled hypertension.
- Sustained systolic Blood Pressure (BP) < 90 mmHg and/or diastolic BP < 50 mmHg on 2 consecutive (duplicate seated) readings at screening.
- Heart failure due to hypertrophic cardiomyopathy, restrictive and/or infiltrative cardiomyopathy, arrhythmogenic right ventricular dysplasia, Fabry disease, or Noonan syndrome with LV hypertrophy or a positive serum immunofixation result.
- Diagnosis of stress-induced (Takotsubo) cardiomyopathy, myocarditis, or peripartum cardiomyopathy.
- Diagnosis of chemotherapy- or radiation-induced cardiomyopathy.
- Diagnosed with stroke or Transient Ischemic Attack (TIA) within 12 weeks of screening.
- History of syncope within the last 12 weeks prior to screening or sustained ventricular tachycardia without an implantable cardioverter-defibrillator.
- Moderate or severe aortic and/or mitral valve stenosis.
- Medically documented unstable angina, acute coronary syndrome (e.g., myocardial infarction, troponin-positive with symptoms of angina or unstable angina) within the last 8 weeks prior to start of screening.
- Medically documented ST-elevation myocardial infarction within 12 weeks of screening.
- Any tachycardia (inclusive of Atrial Fibrillation (AF) or atrial flutter) with a resting ventricular rate > 110 beats per minute at screening.
- For participants with a history of AF or atrial flutter, not on adequate anticoagulant therapy via non-vitamin K oral anticoagulants or warfarin if the CHA2DS2-VASc score is 64 2 in men or 64 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 study duration.
- Symptomatic bradycardia or second (Mobitz Type II)- or third-degree heart block without a pacemaker.
- Cardiac surgery, coronary artery revascularization or indication for coronary artery revascularization, percutaneous coronary intervention, valve repair/replacement or valvuloplasty within 12 weeks prior to screening.
- Implantation of a Cardiac Resynchronization Therapy (CRT) device within 12 weeks prior to screening, or intent to implant a CRT device during the course of the study.
- Previous cardiac transplantation, or any use of mechanical circulatory support or similar device, or implantation expected after randomization.
- Receiving mechanical hemodynamic support or invasive mechanical ventilation within the last 8 weeks prior to screening.
- Receiving Intravenous (IV) inotropes or IV vasopressors within the last 8 weeks prior to screening.
- Receiving IV vasodilators within the last 4 weeks prior to screening.
- Receiving noninvasive mechanical ventilation within the last 4 weeks prior to screening. The use of noninvasive ventilation for sleep disordered breathing is permitted.
AI-Screening
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Trial Site Locations
Total: 62 locations
1
Site 121
Alexander City, Alabama, United States, 35010
Actively Recruiting
2
Site 130
Birmingham, Alabama, United States, 35211
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3
Site 139
Birmingham, Alabama, United States, 35294
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4
Site 138
Huntsville, Alabama, United States, 35801
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5
Site 111
Phoenix, Arizona, United States, 85016
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6
Site 127
Little Rock, Arkansas, United States, 72205
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7
Site 128
Huntington Beach, California, United States, 92648
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8
Site 157
Los Angeles, California, United States, 90033
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9
Site 158
Orange, California, United States, 92868
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10
Site 116
Pasadena, California, United States, 91105
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11
Site 129
Santa Maria, California, United States, 93454
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12
Site 102
Stanford, California, United States, 94305
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13
Site 113
Torrance, California, United States, 90502
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14
Site 133
Vista, California, United States, 92081
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15
Site 161
Coral Gables, Florida, United States, 33134
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16
Site 114
Hialeah, Florida, United States, 33016
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17
Site 162
Miami Lakes, Florida, United States, 33014
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18
Site 159
Naples, Florida, United States, 34104
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19
Site 136
Atlanta, Georgia, United States, 30343
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20
Site 143
Boise, Idaho, United States, 83712
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21
Site 160
Chicago, Illinois, United States, 60611
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22
Site 154
Park Ridge, Illinois, United States, 60068
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23
Site 137
Fort Wayne, Indiana, United States, 46804
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24
Site 112
Indianapolis, Indiana, United States, 46250
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25
Site 104
Covington, Louisiana, United States, 70433
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26
Site 118
Baltimore, Maryland, United States, 21201
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27
Site 119
Boston, Massachusetts, United States, 02114
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28
Site 122
Bloomfield Hills, Michigan, United States, 48304
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29
Site 150
Farmington Hills, Michigan, United States, 48334
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30
Site 107
Rochester, Minnesota, United States, 55905
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31
Site 106
St Louis, Missouri, United States, 63110
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32
Site 105
St Louis, Missouri, United States, 63136
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33
Site 144
Brick, New Jersey, United States, 08724
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34
Site 153
Valhalla, New York, United States, 10595
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35
Site 152
Asheville, North Carolina, United States, 28803
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36
Site 109
Cary, North Carolina, United States, 27518
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37
Site 140
Charlotte, North Carolina, United States, 28204
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38
Site 145
Durham, North Carolina, United States, 27710
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39
Site 117
Cincinnati, Ohio, United States, 45219
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40
Site 100
Cleveland, Ohio, United States, 44195
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41
Site 135
Oklahoma City, Oklahoma, United States, 73135
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42
Site 101
Portland, Oregon, United States, 97239
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43
Site 155
York, Pennsylvania, United States, 17403
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44
Site 110
Dallas, Texas, United States, 75235
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45
Site 115
Dallas, Texas, United States, 75246
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46
Site 103
Houston, Texas, United States, 77030
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47
Site 149
Tomball, Texas, United States, 77375
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48
Site 148
Arlington, Virginia, United States, 22205
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49
Site 123
Falls Church, Virginia, United States, 22042
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50
Site 126
Norfolk, Virginia, United States, 23507
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51
Site 163
Vienna, Virginia, United States, 22182
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52
Site 202
Winnepeg, Manitoba, Canada, R2H2A6
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53
Site 203
Brampton, Ontario, Canada, L6Z 4N5
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54
Site 200
Chicoutimi, Quebec, Canada, G7H 7K9
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55
Site 201
Trois-Rivières, Quebec, Canada, G9A 4P3
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56
Site 305
Changsha, Hunan, China, 410005
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57
Site 303
Nanjing, Jiangsu, China, 210009
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58
Site 306
Jining, Shandong, China, 272100
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59
Site 301
Chengdu, Sichuan, China, 610041
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60
Site 300
Beijing, China, 100037
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61
Site 304
Chongqing, China, 404000
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62
Site 156
Ponce, Puerto Rico, 00717
Actively Recruiting
Research Team
A
Amanda McEwen
CONTACT
A
Ashleigh Chasteen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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