Trial Outcomes & Findings for Open-Label Rollover Study of Levosimendan in PH-HFpEF Patients (NCT NCT03624010)
NCT ID: NCT03624010
Last Updated: 2026-04-22
Results Overview
Number of Adverse Events per Patient Population
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Duration of study (for up to 2 years); Assessed at Weeks 3, 6, 12, 24, and 48 and Follow-Up Visit (termination visit).
Results posted on
2026-04-22
Participant Flow
Patients completing the Phase 2 HELP Study (TNX-LVO-04) were consented to open-label levosimendan.
Participant milestones
| Measure |
Levosimendan Open-Label
Patients received weekly levosimendan IV infusions transitioned to oral levosimendan (1mg capsules)
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Levosimendan Open-Label
Patients received weekly levosimendan IV infusions transitioned to oral levosimendan (1mg capsules)
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
10
|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
not provided
|
2
|
Baseline Characteristics
Open-Label Rollover Study of Levosimendan in PH-HFpEF Patients
Baseline characteristics by cohort
| Measure |
Levosimendan IV Transitioned to Levosimendan Capsules (1mg)
n=35 Participants
Initial: A sterile 2.5 mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for weekly 24 hour infusion. Transitioned To: Levosimendan Capsules (1mg TID)
|
|---|---|
|
Age, Continuous
|
68.3 years
STANDARD_DEVIATION 9.56 • n=60 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=60 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=60 Participants
|
PRIMARY outcome
Timeframe: Duration of study (for up to 2 years); Assessed at Weeks 3, 6, 12, 24, and 48 and Follow-Up Visit (termination visit).Population: All patients consenting to enrollment in the study.
Number of Adverse Events per Patient Population
Outcome measures
| Measure |
Levosimendan Open-Label
n=35 Participants
Initial: A sterile 2.5 mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion. Ongoing patients are transitioned to oral levosimendan (1mg capsules TID)
Levosimendan 2.5 mg/ml Injectable Solution: Initial: A sterile 2.5 mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion. Transioned to: Levosimendan capsules (1 mg)
|
|---|---|
|
Clinical Safety
|
33 Participants
|
Adverse Events
Levosimendan Open-Label
Serious events: 24 serious events
Other events: 15 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Levosimendan Open-Label
n=35 participants at risk
Ongoing patients receiving weekly levosimendan IV infusions transitioned to daily oral levosimendan
|
|---|---|
|
Cardiac disorders
Cardiac disorders
|
37.1%
13/35 • Number of events 13 • 2 years
|
|
Infections and infestations
Infections and infestations
|
31.4%
11/35 • Number of events 11 • 2 years
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
17.1%
6/35 • Number of events 6 • 2 years
|
|
Renal and urinary disorders
Renal and urinary disorders
|
11.4%
4/35 • Number of events 4 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
11.4%
4/35 • Number of events 4 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
8.6%
3/35 • Number of events 3 • 2 years
|
|
General disorders
General disorders
|
8.6%
3/35 • Number of events 3 • 2 years
|
|
Vascular disorders
Vascular disorders
|
8.6%
3/35 • Number of events 3 • 2 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
5.7%
2/35 • Number of events 2 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
5.7%
2/35 • Number of events 2 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign
|
5.7%
2/35 • Number of events 2 • 2 years
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders
|
2.9%
1/35 • Number of events 1 • 2 years
|
|
Nervous system disorders
Nervous system disorders
|
2.9%
1/35 • Number of events 1 • 2 years
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders
|
2.9%
1/35 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
2.9%
1/35 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
Levosimendan Open-Label
n=35 participants at risk
Ongoing patients receiving weekly levosimendan IV infusions transitioned to daily oral levosimendan
|
|---|---|
|
Cardiac disorders
Cardiac disorders
|
17.1%
6/35 • Number of events 6 • 2 years
|
|
Nervous system disorders
Nervous system disorders
|
14.3%
5/35 • Number of events 5 • 2 years
|
|
Product Issues
Product issues
|
11.4%
4/35 • Number of events 4 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
8.6%
3/35 • Number of events 3 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
8.6%
3/35 • Number of events 3 • 2 years
|
|
General disorders
General disorders
|
5.7%
2/35 • Number of events 2 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place