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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522475-28-00 | EU Trial (CTIS) Number |
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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.
Approximately 540 participants will be randomized in a 2:1 ratio to receive an oral dose of levosimendan or placebo. Participants will be eligible for an open label extension (OLE) of 52-weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Matching placebo (oral) |
|
| TNX-103 | Active Comparator | Oral levosimendan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TNX-103 | Drug | Oral levosimendan |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 6-Minute Walk Distance (6MWD) | Change in 6-minute walk distance | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| KCCQ (Kansas City Cardiomyopathy Questionnaire) score is a standardized measure that ranges from 0 to 100, where a higher score indicates better health. | Change in KCCQ Total Symptom Score | 26 weeks |
| Clinical Worsening Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Akshata Ashokkumar | Contact | (919) 855-2118 | a.ashokkumar@tenaxthera.com | |
| Katelyn Jansson | Contact | (919) 855-2119 | k.jansson@tenaxthera.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tenax Investigational Site | Recruiting | Alexander City | Alabama | 35010 | United States | |
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| Drug |
Matching placebo (oral) |
|
Number of Clinical Worsening Events
| 26 weeks |
| Clinical Worsening Event | Time to first occurrence of a Clinical Worsening Event | 26 weeks |
| NYHA (New York Heart Association) classification assesses and categorizes a patient's physical ability and symptoms into four classes, the lower the classification, the least impact on physical activity. | Change in NYHA Functional Class | 26 weeks |
| Tenax Investigational Site |
| Not yet recruiting |
| Tamarac |
| Florida |
| 33321 |
| United States |
| Tenax Investigational Site | Not yet recruiting | Mount Prospect | Illinois | 60056 | United States |
| Tenax Investigational Site | Recruiting | Peoria | Illinois | 61636 | United States |
| Tenax Investigational Site | Recruiting | New Orleans | Louisiana | 70115-6969 | United States |
| Tenax Investigational Site | Recruiting | West Monroe | Louisiana | 71291 | United States |
| Tenax Investigational Site | Not yet recruiting | Ypsilanti | Michigan | 48197 | United States |
| Tenax Investigational Site | Recruiting | Reno | Nevada | 89502 | United States |
| Tenax Investigational Site | Not yet recruiting | New York | New York | 10032 | United States |
| Tenax Investigational Site | Recruiting | Winston-Salem | North Carolina | 27101 | United States |
| Tenax Investigational Site | Not yet recruiting | Allentown | Pennsylvania | 18105 | United States |
| Tenax Investigational Site | Not yet recruiting | Wynnewood | Pennsylvania | 19096-3450 | United States |
| Tenax Investigational Site | Recruiting | Nashville | Tennessee | 37205 | United States |
| Tenax Investigational Site | Recruiting | Austin | Texas | 78705 | United States |
| Tenax Investigational Site | Recruiting | Dallas | Texas | 75390 | United States |
| Tenax Investigational Site | Recruiting | Houston | Texas | 77002 | United States |
| Tenax Investigational Site | Not yet recruiting | Norfolk | Virginia | 23507-1904 | United States |
| Tenax Investigational Site | Not yet recruiting | Marshfield | Wisconsin | 54449 | United States |
| Tenax Investigational Site | Not yet recruiting | Buenos Aires | Buenos Aires F.D. | 1280 | Argentina |
| Tenax Investigational Site | Not yet recruiting | Corrientes | Corrientes Province | W3400AMZ | Argentina |
| Tenax Investigational Site | Not yet recruiting | San Luis | San Luis Province | D5702JRS | Argentina |
| Tenax Investigational Site | Not yet recruiting | Braunau am Inn | 5280 | Austria |
| Tenax Investigational Site | Not yet recruiting | Graz | 8036 | Austria |
| Tenax Investigational Site | Not yet recruiting | Klagenfurt | 9020 | Austria |
| Tenax Investigational Site | Not yet recruiting | Sankt Pölten | 3100 | Austria |
| Tenax Investigational Site | Not yet recruiting | Vienna | 1100 | Austria |
| Tenax Investigational Site | Not yet recruiting | Salvador | Estado de Bahia | 40170-130 | Brazil |
| Tenax Investigational Site | Not yet recruiting | Belo Horizonte | Minas Gerais | 30220 | Brazil |
| Tenax Investigational Site | Not yet recruiting | Curitiba | Paraná | 80215-901 | Brazil |
| Tenax Investigational Site | Not yet recruiting | Ribeirão Preto | São Paulo | 14026-020 | Brazil |
| Tenax Investigational Site | Not yet recruiting | Pleven | 5800 | Bulgaria |
| Tenax Investigational Site | Not yet recruiting | Sofia | 1407 | Bulgaria |
| Tenax Investigational Site | Not yet recruiting | Sofia | 1431 | Bulgaria |
| Tenax Investigational Site | Not yet recruiting | Sofia | 1750 | Bulgaria |
| Tenax Investigational Site | Not yet recruiting | Ostrava | 72880 | Czechia |
| Tenax Investigational Site | Not yet recruiting | Prague | 10034 | Czechia |
| Tenax Investigational Site | Not yet recruiting | Prague | 15006 | Czechia |
| Tenax Investigational Site | Not yet recruiting | Le Kremlin-Bicêtre | 94270 | France |
| Tenax Investigational Site | Not yet recruiting | Montpellier | 34295 | France |
| Tenax Investigational Site | Not yet recruiting | Nantes | 44007 | France |
| Tenax Investigational Site | Not yet recruiting | Nice | 06001 | France |
| Tenax Investigational Site | Not yet recruiting | Pau | 64000 | France |
| Tenax Investigational Site | Not yet recruiting | Bad Bevensen | 29549 | Germany |
| Tenax Investigational Site | Not yet recruiting | Bad Nauheim | 61231 | Germany |
| Tenax Investigational Site | Not yet recruiting | Berlin | 12683 | Germany |
| Tenax Investigational Site | Not yet recruiting | Dresden | 01307 | Germany |
| Tenax Investigational Site | Not yet recruiting | Hamburg | 20251 | Germany |
| Tenax Investigational Site | Not yet recruiting | Jena | 07747 | Germany |
| Tenax Investigational Site | Not yet recruiting | Budapest | 1122 | Hungary |
| Tenax Investigational Site | Not yet recruiting | Budapest | 1134 | Hungary |
| Tenax Investigational Site | Not yet recruiting | Debrecen | 4032 | Hungary |
| Tenax Investigational Site | Not yet recruiting | Szeged | 6275 | Hungary |
| Tenax Investigational Site | Not yet recruiting | Acquaviva delle Fonti | 70021 | Italy |
| Tenax Investigational Site | Not yet recruiting | Messina | 98125 | Italy |
| Tenax Investigational Site | Not yet recruiting | Milan | 20132 | Italy |
| Tenax Investigational Site | Not yet recruiting | Milan | 20138 | Italy |
| Tenax Investigational Site | Not yet recruiting | Milan | 20149 | Italy |
| Tenax Investigational Site | Not yet recruiting | Pavia | 27100 | Italy |
| Tenax Investigational Site | Not yet recruiting | Pisa | 56126 | Italy |
| Tenax Investigational Site | Not yet recruiting | Roma | 00168 | Italy |
| Tenax Investigational Site | Not yet recruiting | Rozzano | 20089 | Italy |
| Tenax Investigational Site | Not yet recruiting | Poznan | 61848 | Poland |
| Tenax Investigational Site | Not yet recruiting | Wroclaw | 50556 | Poland |
| Tenax Investigational Site | Not yet recruiting | Wroclaw | 50891 | Poland |
| Tenax Investigational Site | Not yet recruiting | Cheongju-si | 28644 | South Korea |
| Tenax Investigational Site | Not yet recruiting | Gwangju | 61469 | South Korea |
| Tenax Investigational Site | Not yet recruiting | Incheon | 21565 | South Korea |
| Tenax Investigational Site | Not yet recruiting | Seoul | 03080 | South Korea |
| Tenax Investigational Site | Not yet recruiting | Seoul | 08308 | South Korea |
| Tenax Investigational Site | Not yet recruiting | Wŏnju | 26426 | South Korea |
| Tenax Investigational Site | Not yet recruiting | Barcelona | 08003 | Spain |
| Tenax Investigational Site | Not yet recruiting | Barcelona | 08035 | Spain |
| Tenax Investigational Site | Not yet recruiting | Barcelona | 08036 | Spain |
| Tenax Investigational Site | Not yet recruiting | Lugo | 27003 | Spain |
| Tenax Investigational Site | Not yet recruiting | Madrid | 28041 | Spain |
| Tenax Investigational Site | Not yet recruiting | Madrid | 28046 | Spain |
| Tenax Investigational Site | Not yet recruiting | Madrid | 28055 | Spain |
| Tenax Investigational Site | Not yet recruiting | Marbella | 29603 | Spain |
| Tenax Investigational Site | Not yet recruiting | Málaga | 29010 | Spain |
| Tenax Investigational Site | Not yet recruiting | Pamplona | 31008 | Spain |
| Tenax Investigational Site | Not yet recruiting | Salamanca | 37007 | Spain |
| Tenax Investigational Site | Not yet recruiting | Seville | 41009 | Spain |
| Tenax Investigational Site | Not yet recruiting | Toledo | 45007 | Spain |
| Tenax Investigational Site | Not yet recruiting | Valencia | 46010 | Spain |
| Tenax Investigational Site | Not yet recruiting | Valencia | 46020 | Spain |
| Tenax Investigational Site | Not yet recruiting | Kaohsiung City | 80756 | Taiwan |
| Tenax Investigational Site | Not yet recruiting | Kaohsiung City | 813414 | Taiwan |
| Tenax Investigational Site | Not yet recruiting | Taipei | 10449 | Taiwan |
| Tenax Investigational Site | Not yet recruiting | Taipei | 110 | Taiwan |
| Tenax Investigational Site | Not yet recruiting | Taoyuan | 33305 | Taiwan |
| Tenax Investigational Site | Not yet recruiting | Cambridge | CB233RE | United Kingdom |
| Tenax Investigational Site | Not yet recruiting | Swindon | SN36BB | United Kingdom |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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