LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2
Condition(s) studied
Investigational drug(s) / intervention(s)
TNX-103: Oral levosimendan
Placebo: Matching placebo (oral)
Study summary
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.
Eligibility
Primary outcome measure(s)
- 6-Minute Walk Distance (6MWD) — 26 weeks
Change in 6-minute walk distance
Trial sites (141)
| Facility | City | Region | Status |
|---|---|---|---|
| Tenax Investigational Site | Alexander City | Alabama | Recruiting |
| Tenax Investigational Site | Tucson | Arizona | Not Yet Recruiting |
| Tenax Investigational Site | Sacramento | California | Not Yet Recruiting |
| Tenax Investigational Site | San Francisco | California | Not Yet Recruiting |
| Tenax Investigational Site | Stanford | California | Not Yet Recruiting |
| Tenax Investigational Site | Torrance | California | Not Yet Recruiting |
| Tenax Investigational Site | Athens | Georgia | Not Yet Recruiting |
| Tenax Investigational Site | Atlanta | Georgia | Not Yet Recruiting |
| Tenax Investigational Site | Chicago | Illinois | Not Yet Recruiting |
| Tenax Investigational Site | Chicago | Illinois | Not Yet Recruiting |
| Tenax Investigational Site | Mount Prospect | Illinois | Not Yet Recruiting |
| Tenax Investigational Site | Peoria | Illinois | Recruiting |
| Tenax Investigational Site | Indianapolis | Indiana | Recruiting |
| Tenax Investigational Site | New Orleans | Louisiana | Recruiting |
| Tenax Investigational Site | West Monroe | Louisiana | Recruiting |
| Tenax Investigational Site | Boston | Massachusetts | Not Yet Recruiting |
| Tenax Investigational Site | Ann Arbor | Michigan | Not Yet Recruiting |
| Tenax Investigational Site | Ypsilanti | Michigan | Recruiting |
| Tenax Investigational Site | Minneapolis | Minnesota | Not Yet Recruiting |
| Tenax Investigational Site | Rochester | Minnesota | Not Yet Recruiting |
| Tenax Investigational Site | Kansas City | Missouri | Not Yet Recruiting |
| Tenax Investigational Site | St Louis | Missouri | Not Yet Recruiting |
| Tenax Investigational Site | Omaha | Nebraska | Recruiting |
| Tenax Investigational Site | Reno | Nevada | Recruiting |
| Tenax Investigational Site | New York | New York | Recruiting |
| Tenax Investigational Site | New York | New York | Recruiting |
| Tenax Investigational Site | Rochester | New York | Recruiting |
| Tenax Investigational Site | Durham | North Carolina | Recruiting |
| Tenax Investigational Site | Winston-Salem | North Carolina | Recruiting |
| Tenax Investigational Site | Cleveland | Ohio | Not Yet Recruiting |
| Tenax Investigational Site | Columbus | Ohio | Not Yet Recruiting |
| Tenax Investigational Site | Allentown | Pennsylvania | Not Yet Recruiting |
| Tenax Investigational Site | Pittsburgh | Pennsylvania | Not Yet Recruiting |
| Tenax Investigational Site | Wynnewood | Pennsylvania | Not Yet Recruiting |
| Tenax Investigational Site | Charleston | South Carolina | Not Yet Recruiting |
| Tenax Investigational Site | Nashville | Tennessee | Recruiting |
| Tenax Investigational Site | Austin | Texas | Recruiting |
| Tenax Investigational Site | Dallas | Texas | Recruiting |
| Tenax Investigational Site | El Paso | Texas | Not Yet Recruiting |
| Tenax Investigational Site | Houston | Texas | Withdrawn |
+ 101 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07288398 on ClinicalTrials.gov ↗ ← All trials in Italy