Actively Recruiting
LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2
Led by Tenax Therapeutics, Inc. · Updated on 2026-03-16
540
Participants Needed
92
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess the efficacy and safety of the study drug, levosimendan (given orally), compared to placebo in participants with pulmonary hypertension with heart failure with preserved left ventricular ejection fraction (PH-HFpEF) as measured by the change in 6-Minute Walk Distance.
CONDITIONS
Official Title
LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 18 to 85 years
- New York Heart Association (NYHA) Class II or III symptoms, or ambulatory Class IV symptoms
- Diagnosed with WHO Group 2 pulmonary hypertension with preserved left ventricular ejection fraction
- Qualifying measurements from right heart catheterization and echocardiogram
- Qualifying 6-minute walk distance test
- 48-hour ambulatory heart rhythm monitoring during screening
- Compliance with childbearing potential, contraception, and egg/sperm donation requirements
You will not qualify if you...
- Diagnosis of pulmonary hypertension WHO Groups 1, 3, 4, or 5
- Evidence of hypertrophic, restrictive, infiltrative cardiomyopathy, constrictive pericarditis, or cardiac amyloidosis
- Prior or planned valve repair or replacement, or significant valve disease
- Pre-existing lung disease
- History of severe allergic or anaphylactic reaction to study drug components
- Major surgery within 60 days before study
- Prior heart, lung, or combined transplants or life expectancy under 12 months
- Other serious diseases limiting study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 92 locations
1
Tenax Investigational Site
Alexander City, Alabama, United States, 35010
Actively Recruiting
2
Tenax Investigational Site
Tamarac, Florida, United States, 33321
Not Yet Recruiting
3
Tenax Investigational Site
Mount Prospect, Illinois, United States, 60056
Not Yet Recruiting
4
Tenax Investigational Site
Peoria, Illinois, United States, 61636
Actively Recruiting
5
Tenax Investigational Site
New Orleans, Louisiana, United States, 70115-6969
Actively Recruiting
6
Tenax Investigational Site
West Monroe, Louisiana, United States, 71291
Actively Recruiting
7
Tenax Investigational Site
Ypsilanti, Michigan, United States, 48197
Not Yet Recruiting
8
Tenax Investigational Site
Reno, Nevada, United States, 89502
Actively Recruiting
9
Tenax Investigational Site
New York, New York, United States, 10032
Not Yet Recruiting
10
Tenax Investigational Site
Winston-Salem, North Carolina, United States, 27101
Actively Recruiting
11
Tenax Investigational Site
Allentown, Pennsylvania, United States, 18105
Not Yet Recruiting
12
Tenax Investigational Site
Wynnewood, Pennsylvania, United States, 19096-3450
Not Yet Recruiting
13
Tenax Investigational Site
Nashville, Tennessee, United States, 37205
Actively Recruiting
14
Tenax Investigational Site
Austin, Texas, United States, 78705
Actively Recruiting
15
Tenax Investigational Site
Dallas, Texas, United States, 75390
Actively Recruiting
16
Tenax Investigational Site
Houston, Texas, United States, 77002
Actively Recruiting
17
Tenax Investigational Site
Norfolk, Virginia, United States, 23507-1904
Not Yet Recruiting
18
Tenax Investigational Site
Marshfield, Wisconsin, United States, 54449
Not Yet Recruiting
19
Tenax Investigational Site
Buenos Aires, Buenos Aires F.D., Argentina, 1280
Not Yet Recruiting
20
Tenax Investigational Site
Corrientes, Corrientes Province, Argentina, W3400AMZ
Not Yet Recruiting
21
Tenax Investigational Site
San Luis, San Luis Province, Argentina, D5702JRS
Not Yet Recruiting
22
Tenax Investigational Site
Braunau am Inn, Austria, 5280
Not Yet Recruiting
23
Tenax Investigational Site
Graz, Austria, 8036
Not Yet Recruiting
24
Tenax Investigational Site
Klagenfurt, Austria, 9020
Not Yet Recruiting
25
Tenax Investigational Site
Sankt Pölten, Austria, 3100
Not Yet Recruiting
26
Tenax Investigational Site
Vienna, Austria, 1100
Not Yet Recruiting
27
Tenax Investigational Site
Salvador, Estado de Bahia, Brazil, 40170-130
Not Yet Recruiting
28
Tenax Investigational Site
Belo Horizonte, Minas Gerais, Brazil, 30220
Not Yet Recruiting
29
Tenax Investigational Site
Curitiba, Paraná, Brazil, 80215-901
Not Yet Recruiting
30
Tenax Investigational Site
Ribeirão Preto, São Paulo, Brazil, 14026-020
Not Yet Recruiting
31
Tenax Investigational Site
Pleven, Bulgaria, 5800
Not Yet Recruiting
32
Tenax Investigational Site
Sofia, Bulgaria, 1407
Not Yet Recruiting
33
Tenax Investigational Site
Sofia, Bulgaria, 1431
Not Yet Recruiting
34
Tenax Investigational Site
Sofia, Bulgaria, 1750
Not Yet Recruiting
35
Tenax Investigational Site
Ostrava, Czechia, 72880
Not Yet Recruiting
36
Tenax Investigational Site
Prague, Czechia, 10034
Not Yet Recruiting
37
Tenax Investigational Site
Prague, Czechia, 15006
Not Yet Recruiting
38
Tenax Investigational Site
Le Kremlin-Bicêtre, France, 94270
Not Yet Recruiting
39
Tenax Investigational Site
Montpellier, France, 34295
Not Yet Recruiting
40
Tenax Investigational Site
Nantes, France, 44007
Not Yet Recruiting
41
Tenax Investigational Site
Nice, France, 06001
Not Yet Recruiting
42
Tenax Investigational Site
Pau, France, 64000
Not Yet Recruiting
43
Tenax Investigational Site
Bad Bevensen, Germany, 29549
Not Yet Recruiting
44
Tenax Investigational Site
Bad Nauheim, Germany, 61231
Not Yet Recruiting
45
Tenax Investigational Site
Berlin, Germany, 12683
Not Yet Recruiting
46
Tenax Investigational Site
Dresden, Germany, 01307
Not Yet Recruiting
47
Tenax Investigational Site
Hamburg, Germany, 20251
Not Yet Recruiting
48
Tenax Investigational Site
Jena, Germany, 07747
Not Yet Recruiting
49
Tenax Investigational Site
Budapest, Hungary, 1122
Not Yet Recruiting
50
Tenax Investigational Site
Budapest, Hungary, 1134
Not Yet Recruiting
51
Tenax Investigational Site
Debrecen, Hungary, 4032
Not Yet Recruiting
52
Tenax Investigational Site
Szeged, Hungary, 6275
Not Yet Recruiting
53
Tenax Investigational Site
Acquaviva delle Fonti, Italy, 70021
Not Yet Recruiting
54
Tenax Investigational Site
Messina, Italy, 98125
Not Yet Recruiting
55
Tenax Investigational Site
Milan, Italy, 20132
Not Yet Recruiting
56
Tenax Investigational Site
Milan, Italy, 20138
Not Yet Recruiting
57
Tenax Investigational Site
Milan, Italy, 20149
Not Yet Recruiting
58
Tenax Investigational Site
Pavia, Italy, 27100
Not Yet Recruiting
59
Tenax Investigational Site
Pisa, Italy, 56126
Not Yet Recruiting
60
Tenax Investigational Site
Roma, Italy, 00168
Not Yet Recruiting
61
Tenax Investigational Site
Rozzano, Italy, 20089
Not Yet Recruiting
62
Tenax Investigational Site
Poznan, Poland, 61848
Not Yet Recruiting
63
Tenax Investigational Site
Wroclaw, Poland, 50556
Not Yet Recruiting
64
Tenax Investigational Site
Wroclaw, Poland, 50891
Not Yet Recruiting
65
Tenax Investigational Site
Cheongju-si, South Korea, 28644
Not Yet Recruiting
66
Tenax Investigational Site
Gwangju, South Korea, 61469
Not Yet Recruiting
67
Tenax Investigational Site
Incheon, South Korea, 21565
Not Yet Recruiting
68
Tenax Investigational Site
Seoul, South Korea, 03080
Not Yet Recruiting
69
Tenax Investigational Site
Seoul, South Korea, 08308
Not Yet Recruiting
70
Tenax Investigational Site
Wŏnju, South Korea, 26426
Not Yet Recruiting
71
Tenax Investigational Site
Barcelona, Spain, 08003
Not Yet Recruiting
72
Tenax Investigational Site
Barcelona, Spain, 08035
Not Yet Recruiting
73
Tenax Investigational Site
Barcelona, Spain, 08036
Not Yet Recruiting
74
Tenax Investigational Site
Lugo, Spain, 27003
Not Yet Recruiting
75
Tenax Investigational Site
Madrid, Spain, 28041
Not Yet Recruiting
76
Tenax Investigational Site
Madrid, Spain, 28046
Not Yet Recruiting
77
Tenax Investigational Site
Madrid, Spain, 28055
Not Yet Recruiting
78
Tenax Investigational Site
Marbella, Spain, 29603
Not Yet Recruiting
79
Tenax Investigational Site
Málaga, Spain, 29010
Not Yet Recruiting
80
Tenax Investigational Site
Pamplona, Spain, 31008
Not Yet Recruiting
81
Tenax Investigational Site
Salamanca, Spain, 37007
Not Yet Recruiting
82
Tenax Investigational Site
Seville, Spain, 41009
Not Yet Recruiting
83
Tenax Investigational Site
Toledo, Spain, 45007
Not Yet Recruiting
84
Tenax Investigational Site
Valencia, Spain, 46010
Not Yet Recruiting
85
Tenax Investigational Site
Valencia, Spain, 46020
Not Yet Recruiting
86
Tenax Investigational Site
Kaohsiung City, Taiwan, 80756
Not Yet Recruiting
87
Tenax Investigational Site
Kaohsiung City, Taiwan, 813414
Not Yet Recruiting
88
Tenax Investigational Site
Taipei, Taiwan, 10449
Not Yet Recruiting
89
Tenax Investigational Site
Taipei, Taiwan, 110
Not Yet Recruiting
90
Tenax Investigational Site
Taoyuan, Taiwan, 33305
Not Yet Recruiting
91
Tenax Investigational Site
Cambridge, United Kingdom, CB233RE
Not Yet Recruiting
92
Tenax Investigational Site
Swindon, United Kingdom, SN36BB
Not Yet Recruiting
Research Team
A
Akshata Ashokkumar
CONTACT
K
Katelyn Jansson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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