Trial Outcomes & Findings for Metformin in Heart Failure Without Diabetes (NCT NCT03331861)
NCT ID: NCT03331861
Last Updated: 2024-07-18
Results Overview
The VO2 change outcomes will be assessed for normality using standard visual assessments (Q-Q plots and histograms) and statistical tests (Kolmogorov-Smirnov). VE/VCO2 slope change will be calculated.
TERMINATED
PHASE2
6 participants
Baseline and 6 months
2024-07-18
Participant Flow
2 out of 6 participants screen failed and no further information was collected or analyzed.
Participant milestones
| Measure |
Metformin
Metformin for 6 months
Metformin hydrochloride: Metformin starting at 500mg twice a day and increasing to 1000mg twice a day for a total of 6 months
|
Placebo
Matched placebo for 6 months
Placebo: Similar dosing regime as active comparator
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Metformin in Heart Failure Without Diabetes
Baseline characteristics by cohort
| Measure |
Metformin
n=2 Participants
Metformin for 6 months
Metformin hydrochloride: Metformin starting at 500mg twice a day and increasing to 1000mg twice a day for a total of 6 months
|
Placebo
n=2 Participants
Matched placebo for 6 months
Placebo: Similar dosing regime as active comparator
|
Total
n=4 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
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 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
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 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
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: Study was terminated early; data was not collected due to low enrollment, thus cannot be analyzed.
The VO2 change outcomes will be assessed for normality using standard visual assessments (Q-Q plots and histograms) and statistical tests (Kolmogorov-Smirnov). VE/VCO2 slope change will be calculated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: Study was terminated early; data was not collected due to low enrollment, thus cannot be analyzed.
Dyspnea Assessment. 100mm line scale ranging from 0 (worse imaginable breathing) to 100 (best imaginable breathing).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: Study was terminated early; data was not collected due to low enrollment, thus cannot be analyzed.
A validated patient-oriented measure of the adverse effects of heart failure on a patient's life. The questionnaire is comprised of 21 questions around several physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. After receiving brief standardized instructions, the patient marks a 0 (zero) to 5 (five) scale to indicate the extent to which each itemized adversity of heart failure has prevented the patient from living as they wanted to live during the past 4 weeks. The questionnaire is simply scored by summation of all 21 responses.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: Study was terminated early; data was not collected due to low enrollment, thus cannot be analyzed.
Oxygen consumption (VO2) (ml/min) will be measured on a breath by breath basis. Peak VO2 will be computed using standard methods.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Study was terminated early; data was not collected due to low enrollment, thus cannot be analyzed.
The number of hospitalizations recorded during the study will be tallied.
Outcome measures
Outcome data not reported
Adverse Events
Metformin
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Barry Fine, MD
Columbia University Irving Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place