Trial Outcomes & Findings for Cardiometabolic Disease and Pulmonary Hypertension (NCT NCT03349775)
NCT ID: NCT03349775
Last Updated: 2022-01-21
Results Overview
The metformin and placebo groups will be compared with respect to resting mean pulmonary artery pressure (mmHg)
Recruitment status
TERMINATED
Study phase
EARLY_PHASE1
Target enrollment
21 participants
Primary outcome timeframe
Baseline and 3 months
Results posted on
2022-01-21
Participant Flow
Participant milestones
| Measure |
Metformin
Metformin: 500mg tablet orally twice daily for 1 week, followed by two 500mg tablets orally twice daily for a total of 3 months.
|
Placebo
Placebo: 500 mg tablet orally twice daily for 1 week, followed by two 500 mg tablets orally twice daily for a total of 3 months.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
|
Overall Study
COMPLETED
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
Metformin
Metformin: 500mg tablet orally twice daily for 1 week, followed by two 500mg tablets orally twice daily for a total of 3 months.
|
Placebo
Placebo: 500 mg tablet orally twice daily for 1 week, followed by two 500 mg tablets orally twice daily for a total of 3 months.
|
|---|---|---|
|
Overall Study
Side Effects
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
No primary outcome measurements
|
0
|
1
|
Baseline Characteristics
Cardiometabolic Disease and Pulmonary Hypertension
Baseline characteristics by cohort
| Measure |
Metformin
n=8 Participants
Metformin: 500mg tablet orally twice daily for 1 week, followed by two 500mg tablets orally twice daily for a total of 3 months.
|
Placebo
n=7 Participants
Placebo: 500 mg tablet orally twice daily for 1 week, followed by two 500 mg tablets orally twice daily for a total of 3 months.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 10 • n=99 Participants
|
60 years
STANDARD_DEVIATION 10 • n=107 Participants
|
63 years
STANDARD_DEVIATION 10 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 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
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 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
|
|
Height
|
65.1 inches
STANDARD_DEVIATION 2.9 • n=99 Participants
|
67.7 inches
STANDARD_DEVIATION 4.2 • n=107 Participants
|
66.3 inches
STANDARD_DEVIATION 3.7 • n=206 Participants
|
|
Weight
|
212.9 pounds
STANDARD_DEVIATION 44.1 • n=99 Participants
|
224.0 pounds
STANDARD_DEVIATION 32.9 • n=107 Participants
|
218.1 pounds
STANDARD_DEVIATION 38.3 • n=206 Participants
|
|
Body Mass Index (BMI)
|
35.3 kg/m^2
STANDARD_DEVIATION 6.0 • n=99 Participants
|
34.4 kg/m^2
STANDARD_DEVIATION 4.6 • n=107 Participants
|
34.9 kg/m^2
STANDARD_DEVIATION 5.2 • n=206 Participants
|
|
Heart Rate (HR)
|
70 beats per minute (bpm)
STANDARD_DEVIATION 13 • n=99 Participants
|
70 beats per minute (bpm)
STANDARD_DEVIATION 15 • n=107 Participants
|
70 beats per minute (bpm)
STANDARD_DEVIATION 14 • n=206 Participants
|
|
Systolic Blood Pressure (SBP)
|
133 mmHg
STANDARD_DEVIATION 18 • n=99 Participants
|
142 mmHg
STANDARD_DEVIATION 14 • n=107 Participants
|
137 mmHg
STANDARD_DEVIATION 17 • n=206 Participants
|
|
Diastolic Blood Pressure (DBP)
|
80 mmHg
STANDARD_DEVIATION 8 • n=99 Participants
|
86 mmHg
STANDARD_DEVIATION 11 • n=107 Participants
|
83 mmHg
STANDARD_DEVIATION 9 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsThe metformin and placebo groups will be compared with respect to resting mean pulmonary artery pressure (mmHg)
Outcome measures
| Measure |
Metformin
n=8 Participants
Metformin: 500mg tablet orally twice daily for 1 week, followed by two 500mg tablets orally twice daily for a total of 3 months.
|
Placebo
n=7 Participants
Placebo: 500 mg tablet orally twice daily for 1 week, followed by two 500 mg tablets orally twice daily for a total of 3 months.
|
|---|---|---|
|
Pulmonary Vascular Hemodynamics (Rest)
|
-3.00 mmHg
Standard Deviation 5.35
|
-0.43 mmHg
Standard Deviation 4.89
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsThe metformin and placebo groups will be compared with respect to augmentation of mean pulmonary artery pressure divided by augmentation of cardiac output during cardiopulmonary exercise testing (change in mean PAP divided by change in cardiac output from rest to peak exercise)
Outcome measures
| Measure |
Metformin
n=8 Participants
Metformin: 500mg tablet orally twice daily for 1 week, followed by two 500mg tablets orally twice daily for a total of 3 months.
|
Placebo
n=7 Participants
Placebo: 500 mg tablet orally twice daily for 1 week, followed by two 500 mg tablets orally twice daily for a total of 3 months.
|
|---|---|---|
|
Pulmonary Vascular Hemodynamics (Exercise)
|
-0.29 mmHg/L/min
Standard Deviation 0.83
|
-1.42 mmHg/L/min
Standard Deviation 3.00
|
SECONDARY outcome
Timeframe: baseline and 3 monthsWe will compare the metformin and placebo groups. Specifically we will examine the following pulmonary artery endothelial cell phenotypes: (1) activation of phospho-eNOS as detected by immunofluorescence staining
Outcome measures
Outcome data not reported
Adverse Events
Metformin
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Metformin
n=10 participants at risk
Metformin: 500mg tablet orally twice daily for 1 week, followed by two 500mg tablets orally twice daily for a total of 3 months.
|
Placebo
n=11 participants at risk
Placebo: 500 mg tablet orally twice daily for 1 week, followed by two 500 mg tablets orally twice daily for a total of 3 months.
|
|---|---|---|
|
Cardiac disorders
Left arm numbness and chest pain
|
0.00%
0/10 • Adverse event data were collected for the metformin and placebo groups over the course of the 3 months on randomized assignment to study drug.
|
9.1%
1/11 • Adverse event data were collected for the metformin and placebo groups over the course of the 3 months on randomized assignment to study drug.
|
Other adverse events
| Measure |
Metformin
n=10 participants at risk
Metformin: 500mg tablet orally twice daily for 1 week, followed by two 500mg tablets orally twice daily for a total of 3 months.
|
Placebo
n=11 participants at risk
Placebo: 500 mg tablet orally twice daily for 1 week, followed by two 500 mg tablets orally twice daily for a total of 3 months.
|
|---|---|---|
|
Gastrointestinal disorders
Acid Reflux
|
10.0%
1/10 • Number of events 2 • Adverse event data were collected for the metformin and placebo groups over the course of the 3 months on randomized assignment to study drug.
|
0.00%
0/11 • Adverse event data were collected for the metformin and placebo groups over the course of the 3 months on randomized assignment to study drug.
|
|
Gastrointestinal disorders
GI upset (e.g. nausea, diarrhea, vomiting, abdominal discomfort, flatulence)
|
70.0%
7/10 • Number of events 11 • Adverse event data were collected for the metformin and placebo groups over the course of the 3 months on randomized assignment to study drug.
|
36.4%
4/11 • Number of events 5 • Adverse event data were collected for the metformin and placebo groups over the course of the 3 months on randomized assignment to study drug.
|
|
General disorders
Fatigue/Weakness
|
0.00%
0/10 • Adverse event data were collected for the metformin and placebo groups over the course of the 3 months on randomized assignment to study drug.
|
18.2%
2/11 • Adverse event data were collected for the metformin and placebo groups over the course of the 3 months on randomized assignment to study drug.
|
|
Skin and subcutaneous tissue disorders
Itching and rash/hives
|
10.0%
1/10 • Number of events 2 • Adverse event data were collected for the metformin and placebo groups over the course of the 3 months on randomized assignment to study drug.
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected for the metformin and placebo groups over the course of the 3 months on randomized assignment to study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle or joint soreness
|
0.00%
0/10 • Adverse event data were collected for the metformin and placebo groups over the course of the 3 months on randomized assignment to study drug.
|
27.3%
3/11 • Adverse event data were collected for the metformin and placebo groups over the course of the 3 months on randomized assignment to study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma Flare
|
0.00%
0/10 • Adverse event data were collected for the metformin and placebo groups over the course of the 3 months on randomized assignment to study drug.
|
9.1%
1/11 • Adverse event data were collected for the metformin and placebo groups over the course of the 3 months on randomized assignment to study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.00%
0/10 • Adverse event data were collected for the metformin and placebo groups over the course of the 3 months on randomized assignment to study drug.
|
9.1%
1/11 • Adverse event data were collected for the metformin and placebo groups over the course of the 3 months on randomized assignment to study drug.
|
|
General disorders
Non-Specific Symptoms
|
0.00%
0/10 • Adverse event data were collected for the metformin and placebo groups over the course of the 3 months on randomized assignment to study drug.
|
9.1%
1/11 • Adverse event data were collected for the metformin and placebo groups over the course of the 3 months on randomized assignment to study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place