Trial Outcomes & Findings for Treatment of HFpEF With Nitrate Supplement (NCT NCT03289481)
NCT ID: NCT03289481
Last Updated: 2021-10-06
Results Overview
change in total time traveled on treadmill
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
13 participants
Primary outcome timeframe
after one week of active lozenges compared to one week of placebo lozenges
Results posted on
2021-10-06
Participant Flow
This study was a cross over case-control study (each subject was a control for themselves).
Participant milestones
| Measure |
Active Lozenge First
Subject will take active lozenge for one week, perform cardiac testing then take placebo lozenge for one week and perform cardiac testing.
Active lozenge: nitric oxide generating lozenge
|
Placebo Lozenge First
Subject will take placebo lozenge for one week, perform cardiac testing then take active lozenge for one week and perform cardiac testing.
Active lozenge: nitric oxide generating lozenge
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
|
Overall Study
COMPLETED
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of HFpEF With Nitrate Supplement
Baseline characteristics by cohort
| Measure |
Active Lozenge First
n=4 Participants
Subject will take active lozenge for one week, perform cardiac testing then take placebo lozenge for one week and perform cardiac testing.
Active lozenge: nitric oxide generating lozenge
|
Placebo Lozenge First
n=5 Participants
Subject will take placebo lozenge for one week, perform cardiac testing then take active lozenge for one week and perform cardiac testing.
Active lozenge: nitric oxide generating lozenge
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=99 Participants
|
5 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Diagnosis of HFpEF
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: after one week of active lozenges compared to one week of placebo lozengeschange in total time traveled on treadmill
Outcome measures
| Measure |
Active Lozenge
n=9 Participants
Participants who received Neo40 (active lozenge) in either the first week or the last week of the study.
|
Placebo
n=9 Participants
Participants who received the placebo (matching Neo40) in either the first week or the last week of the study.
|
|---|---|---|
|
Time on Treadmill
|
402.8 seconds
Interval 156.0 to 729.0
|
181.2 seconds
Interval 180.0 to 660.0
|
PRIMARY outcome
Timeframe: after one week of active lozenges compared to one week of placebo lozengeschange in metabolic equivalents on treadmill
Outcome measures
| Measure |
Active Lozenge
n=9 Participants
Participants who received Neo40 (active lozenge) in either the first week or the last week of the study.
|
Placebo
n=9 Participants
Participants who received the placebo (matching Neo40) in either the first week or the last week of the study.
|
|---|---|---|
|
Metabolic Equivalents
|
7.99 cal/min
Interval 4.2 to 12.8
|
8.46 cal/min
Interval 4.2 to 12.8
|
PRIMARY outcome
Timeframe: after one week of active lozenges compared to one week of placebo lozengeschange in E/E prime on exercise echo (E/E prime is a ratio between early mitral inflow velocity and mitral annular early diastolic velocity in order to measure diastolic dysfunction)
Outcome measures
| Measure |
Active Lozenge
n=9 Participants
Participants who received Neo40 (active lozenge) in either the first week or the last week of the study.
|
Placebo
n=9 Participants
Participants who received the placebo (matching Neo40) in either the first week or the last week of the study.
|
|---|---|---|
|
E/E Prime
|
1.93 ratio
Interval -6.2 to 8.0
|
-.05 ratio
Interval -6.8 to 2.4
|
PRIMARY outcome
Timeframe: after one week of active lozenges compared to one week of placebo lozengeschange in estimated right ventricular systolic pressure on echo
Outcome measures
| Measure |
Active Lozenge
n=9 Participants
Participants who received Neo40 (active lozenge) in either the first week or the last week of the study.
|
Placebo
n=9 Participants
Participants who received the placebo (matching Neo40) in either the first week or the last week of the study.
|
|---|---|---|
|
Estimated Right Ventricular Systolic Pressure
|
11.79 mmHg
Interval 5.0 to 27.0
|
8.6 mmHg
Interval -1.2 to 28.0
|
Adverse Events
Active Lozenge
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Lozenge
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place