Phase
Condition
Hyponatremia
Chest Pain
Heart Failure
Treatment
TNX-103
Placebo
Clinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Men or women, ≥18 to 85 years of age
NYHA Class II or III or ambulatory NYHA Class IV symptoms
A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifyinghemodynamics verified by right heart catheterization (RHC)
A qualifying baseline RHC
A qualifying echocardiogram
A qualifying 6-MWD
A 48-hour ambulatory cardiac rhythm monitor during the Screening Period
Requirements related to child bearing potential, contraception, and egg/spermdonation)
Exclusion
Exclusion Criteria:
A diagnosis of PH WHO Groups 1, 3, 4, or 5
Echocardiographic evidence for hypertrophic cardiomyopathy, restrictivecardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or infiltrativecardiomyopathy
Structural heart repair or replacement of the aortic valve or mitral valve (surgicalor percutaneous) OR, planned valve intervention OR, the presence of significantvalve disease
A diagnosis of pre-existing lung disease
History of severe allergic or anaphylactic reaction or hypersensitivity to theexcipients in the investigational product
Major surgery within 60 days
Prior heart, lung, or heart-lung transplants or life expectancy of <12 months
History of clinically significant other diseases that may limit or complicateparticipation in the study
Study Design
Study Description
Connect with a study center
Tenax Investigational Site
Buenos Aires 3435910, Buenos Aires F.D. 3433955 1280
ArgentinaSite Not Available
Tenax Investigational Site
Corrientes 3435217, Corrientes Province 3435214 W3400AMZ
ArgentinaSite Not Available
Tenax Investigational Site
San Luis 3837056, San Luis Province 3837029 D5702JRS
ArgentinaSite Not Available
Tenax Investigational Site
Braunau am Inn 2781520, 5280
AustriaSite Not Available
Tenax Investigational Site
Graz 2778067, 8036
AustriaSite Not Available
Tenax Investigational Site
Klagenfurt 2774326, 9020
AustriaSite Not Available
Tenax Investigational Site
Sankt Pölten 2766429, 3100
AustriaSite Not Available
Tenax Investigational Site
Vienna 2761369, 1100
AustriaSite Not Available
Tenax Investigational Site
Salvador 3450554, Estado de Bahia 3471168 40170-130
BrazilSite Not Available
Tenax Investigational Site
Belo Horizonte 3470127, Minas Gerais 3457153 30220
BrazilSite Not Available
Tenax Investigational Site
Curitiba 3464975, Paraná 3455077 80215-901
BrazilSite Not Available
Tenax Investigational Site
Ribeirão Preto 3451328, São Paulo 3448433 14026-020
BrazilSite Not Available
Tenax Investigational Site
Pleven 728203, 5800
BulgariaSite Not Available
Tenax Investigational Site
Sofia 727011, 1407
BulgariaSite Not Available
Tenax Investigational Site
Ostrava 3068799, 72880
CzechiaSite Not Available
Tenax Investigational Site
Prague 3067696, 15006
CzechiaSite Not Available
Tenax Investigational Site
Le Kremlin-Bicêtre 3003737, 94270
FranceSite Not Available
Tenax Investigational Site
Montpellier 2992166, 34295
FranceSite Not Available
Tenax Investigational Site
Nantes 2990969, 44007
FranceSite Not Available
Tenax Investigational Site
Nice 2990440, 06001
FranceSite Not Available
Tenax Investigational Site
Pau 2988358, 64000
FranceSite Not Available
Tenax Investigational Site
Bad Bevensen 2949511, 29549
GermanySite Not Available
Tenax Investigational Site
Bad Nauheim 2953395, 61231
GermanySite Not Available
Tenax Investigational Site
Berlin 2950159, 12683
GermanySite Not Available
Tenax Investigational Site
Dresden 2935022, 01307
GermanySite Not Available
Tenax Investigational Site
Hamburg 2911298, 20251
GermanySite Not Available
Tenax Investigational Site
Jena 2895044, 07747
GermanySite Not Available
Tenax Investigational Site
Budapest 3054643, 1134
HungarySite Not Available
Tenax Investigational Site
Debrecen 721472, 4032
HungarySite Not Available
Tenax Investigational Site
Szeged 715429, 6275
HungarySite Not Available
Tenax Investigational Site
Acquaviva delle Fonti 3183494, 70021
ItalySite Not Available
Tenax Investigational Site
Messina 2524170, 98125
ItalySite Not Available
Tenax Investigational Site
Milan 6951411, 20132
ItalySite Not Available
Tenax Investigational Site
Pavia 3171366, 27100
ItalySite Not Available
Tenax Investigational Site
Pisa 3170647, 56126
ItalySite Not Available
Tenax Investigational Site
Roma 8957247, 00168
ItalySite Not Available
Tenax Investigational Site
Rozzano 3168837, 20089
ItalySite Not Available
Tenax Investigational Site
Poznan 3088171, 61848
PolandSite Not Available
Tenax Investigational Site
Wroclaw 3081368, 50556
PolandSite Not Available
Tenax Investigational Site
Cheongju-si 1845604, 28644
South KoreaSite Not Available
Tenax Investigational Site
Gwangju 1841811, 61469
South KoreaSite Not Available
Tenax Investigational Site
Incheon 1843564, 21565
South KoreaSite Not Available
Tenax Investigational Site
Seoul 1835848, 03080
South KoreaSite Not Available
Tenax Investigational Site
Wŏnju 1833105, 26426
South KoreaSite Not Available
Tenax Investigational Site
Barcelona 3128760, 08035
SpainSite Not Available
Tenax Investigational Site
Lugo 3117814, 27003
SpainSite Not Available
Tenax Investigational Site
Madrid 3117735, 28046
SpainSite Not Available
Tenax Investigational Site
Marbella 2514169, 29603
SpainSite Not Available
Tenax Investigational Site
Málaga 2514256, 29010
SpainSite Not Available
Tenax Investigational Site
Pamplona 3114472, 31008
SpainSite Not Available
Tenax Investigational Site
Salamanca 3111108, 37007
SpainSite Not Available
Tenax Investigational Site
Seville 2510911, 41009
SpainSite Not Available
Tenax Investigational Site
Toledo 2510409, 45007
SpainSite Not Available
Tenax Investigational Site
Valencia 2509954, 46020
SpainSite Not Available
Tenax Investigational Site
Kaohsiung City 1673820, 813414
TaiwanSite Not Available
Tenax Investigational Site
Taipei 1668341, 10449
TaiwanSite Not Available
Tenax Investigational Site
Taoyuan District 1667905, 33305
TaiwanSite Not Available
Tenax Investigational Site
Cambridge 2653941, CB233RE
United KingdomSite Not Available
Tenax Investigational Site
Swindon 2636389, SN36BB
United KingdomSite Not Available
Tenax Investigational Site
Alexander City 4829843, Alabama 4829764 35010
United StatesSite Not Available
Tenax Investigational Site
Tamarac 4174738, Florida 4155751 33321
United StatesSite Not Available
Tenax Investigational Site
Mount Prospect 4903024, Illinois 4896861 60056
United StatesSite Not Available
Tenax Investigational Site
Peoria 4905687, Illinois 4896861 61636
United StatesSite Not Available
Tenax Investigational Site
New Orleans 4335045, Louisiana 4331987 70115-6969
United StatesSite Not Available
Tenax Investigational Site
West Monroe 4345850, Louisiana 4331987 71291
United StatesSite Not Available
Tenax Investigational Site
Ypsilanti 5015688, Michigan 5001836 48197
United StatesSite Not Available
Tenax Investigational Site
Reno 5511077, Nevada 5509151 89502
United StatesSite Not Available
Tenax Investigational Site
New York 5128581, New York 5128638 10032
United StatesSite Not Available
Tenax Investigational Site
Winston-Salem 4499612, North Carolina 4482348 27101
United StatesSite Not Available
Tenax Investigational Site
Allentown 5178127, Pennsylvania 6254927 18105
United StatesSite Not Available
Tenax Investigational Site
Wynnewood 5220230, Pennsylvania 6254927 19096-3450
United StatesSite Not Available
Tenax Investigational Site
Nashville 4644585, Tennessee 4662168 37205
United StatesSite Not Available
Tenax Investigational Site
Austin 4671654, Texas 4736286 78705
United StatesSite Not Available
Tenax Investigational Site
Houston 4699066, Texas 4736286 77002
United StatesActive - Recruiting
Tenax Investigational Site
Norfolk 4776222, Virginia 6254928 23507-1904
United StatesSite Not Available
Tenax Investigational Site
Marshfield 5261969, Wisconsin 5279468 54449
United StatesSite Not Available

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