Trial Outcomes & Findings for Dapagliflozin (DAPA) Effects in HFpEF (NCT NCT04730947)
NCT ID: NCT04730947
Last Updated: 2023-10-12
Results Overview
Pulmonary capillary wedge pressure is a measure of cardiac filling pressure, measured using a high-fidelity micromanometer advanced through the lumen of a fluid-filled catheter during exercise.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
Baseline, 24 weeks
Results posted on
2023-10-12
Participant Flow
Participant milestones
| Measure |
Dapagliflozin Group
Subjects with heart failure/preserved ejection fraction (HFpEF) will take the study drug dapagliflozin daily
Dapagliflozin: 10 mg orally once a day
|
Placebo Group
Subjects with HFpEF will take a placebo daily
Placebo: Taken orally once a day, the placebo looks identical to the study drug but it contains no active ingredient
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
17
|
|
Overall Study
COMPLETED
|
21
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Dapagliflozin Group
Subjects with heart failure/preserved ejection fraction (HFpEF) will take the study drug dapagliflozin daily
Dapagliflozin: 10 mg orally once a day
|
Placebo Group
Subjects with HFpEF will take a placebo daily
Placebo: Taken orally once a day, the placebo looks identical to the study drug but it contains no active ingredient
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Dapagliflozin Group
n=21 Participants
Subjects with HFpEF will take the study drug dapagliflozin daily
Dapagliflozin: 10 mg orally once a day
|
Placebo Group
n=17 Participants
Subjects with HFpEF will take a placebo daily
Placebo: Taken orally once a day, the placebo looks identical to the study drug but it contains no active ingredient
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 9 • n=21 Participants
|
67 years
STANDARD_DEVIATION 9 • n=17 Participants
|
67 years
STANDARD_DEVIATION 9 • n=38 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=21 Participants
|
11 Participants
n=17 Participants
|
25 Participants
n=38 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=21 Participants
|
6 Participants
n=17 Participants
|
13 Participants
n=38 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
21 participants
n=21 Participants
|
17 participants
n=17 Participants
|
38 participants
n=38 Participants
|
PRIMARY outcome
Timeframe: Baseline, 24 weeksPulmonary capillary wedge pressure is a measure of cardiac filling pressure, measured using a high-fidelity micromanometer advanced through the lumen of a fluid-filled catheter during exercise.
Outcome measures
| Measure |
Dapagliflozin Group
n=21 Participants
Subjects with HFpEF will take the study drug dapagliflozin daily
Dapagliflozin: 10 mg orally once a day
|
Placebo Group
n=16 Participants
Subjects with HFpEF will take a placebo daily
Placebo: Taken orally once a day, the placebo looks identical to the study drug but it contains no active ingredient
|
|---|---|---|
|
Pulmonary Capillary Wedge Pressure (PCWP) at Maximal Exercise
|
-6.6 mmHg
Standard Deviation 7.2
|
-0.4 mmHg
Standard Deviation 8.4
|
PRIMARY outcome
Timeframe: Baseline, 24 weeksPulmonary capillary wedge pressure is a measure of cardiac filling pressure, measured using a high-fidelity micromanometer advanced through the lumen of a fluid-filled catheter during rest.
Outcome measures
| Measure |
Dapagliflozin Group
n=21 Participants
Subjects with HFpEF will take the study drug dapagliflozin daily
Dapagliflozin: 10 mg orally once a day
|
Placebo Group
n=16 Participants
Subjects with HFpEF will take a placebo daily
Placebo: Taken orally once a day, the placebo looks identical to the study drug but it contains no active ingredient
|
|---|---|---|
|
Pulmonary Capillary Wedge Pressure (PCWP) at Rest
|
-2.5 mmHg
Standard Deviation 3.7
|
1.1 mmHg
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksChange in body weight as measured in kilograms (kg)
Outcome measures
| Measure |
Dapagliflozin Group
n=21 Participants
Subjects with HFpEF will take the study drug dapagliflozin daily
Dapagliflozin: 10 mg orally once a day
|
Placebo Group
n=16 Participants
Subjects with HFpEF will take a placebo daily
Placebo: Taken orally once a day, the placebo looks identical to the study drug but it contains no active ingredient
|
|---|---|---|
|
Change in Body Weight
|
-3.7 kg
Standard Deviation 4.2
|
-0.2 kg
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksTotal blood volume was assessed using a radiolabeled iodinated albumin (131I, 5-25 μCu) indicator dilution technique with the BVA-100 Blood Volume Analyzer. Measured in millimeters (mL)
Outcome measures
| Measure |
Dapagliflozin Group
n=21 Participants
Subjects with HFpEF will take the study drug dapagliflozin daily
Dapagliflozin: 10 mg orally once a day
|
Placebo Group
n=16 Participants
Subjects with HFpEF will take a placebo daily
Placebo: Taken orally once a day, the placebo looks identical to the study drug but it contains no active ingredient
|
|---|---|---|
|
Change in Total Blood Volume
|
-118 mL
Standard Deviation 542
|
142 mL
Standard Deviation 399
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPlasma volume was assessed using a radiolabeled iodinated albumin (131I, 5-25 μCu) indicator dilution technique with the BVA-100 Blood Volume Analyzer. Measured in millimeters (mL)
Outcome measures
| Measure |
Dapagliflozin Group
n=21 Participants
Subjects with HFpEF will take the study drug dapagliflozin daily
Dapagliflozin: 10 mg orally once a day
|
Placebo Group
n=16 Participants
Subjects with HFpEF will take a placebo daily
Placebo: Taken orally once a day, the placebo looks identical to the study drug but it contains no active ingredient
|
|---|---|---|
|
Change in Plasma Volume
|
-170 mL
Standard Deviation 343
|
115 mL
Standard Deviation 322
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksRight Atrial (RA) pressure is a measure of cardiac filling pressure, measured using a high-fidelity micromanometer advanced through the lumen of a fluid-filled catheter during exercise.
Outcome measures
| Measure |
Dapagliflozin Group
n=21 Participants
Subjects with HFpEF will take the study drug dapagliflozin daily
Dapagliflozin: 10 mg orally once a day
|
Placebo Group
n=16 Participants
Subjects with HFpEF will take a placebo daily
Placebo: Taken orally once a day, the placebo looks identical to the study drug but it contains no active ingredient
|
|---|---|---|
|
Change in Right Atrial (RA) Pressure at Maximal Exercise
|
-3.4 mmHg
Standard Deviation 4.0
|
0.8 mmHg
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksRight Atrial (RA) pressure is a measure of cardiac filling pressure, measured using a high-fidelity micromanometer advanced through the lumen of a fluid-filled catheter during rest.
Outcome measures
| Measure |
Dapagliflozin Group
n=21 Participants
Subjects with HFpEF will take the study drug dapagliflozin daily
Dapagliflozin: 10 mg orally once a day
|
Placebo Group
n=16 Participants
Subjects with HFpEF will take a placebo daily
Placebo: Taken orally once a day, the placebo looks identical to the study drug but it contains no active ingredient
|
|---|---|---|
|
Change in Right Atrial (RA) Pressure at Rest
|
-1.6 mmHg
Standard Deviation 2.6
|
0.3 mmHg
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPulmonary Arterial (PA) pressure is a measure of cardiac filling pressure, measured using a high-fidelity micromanometer advanced through the lumen of a fluid-filled catheter during exercise.
Outcome measures
| Measure |
Dapagliflozin Group
n=21 Participants
Subjects with HFpEF will take the study drug dapagliflozin daily
Dapagliflozin: 10 mg orally once a day
|
Placebo Group
n=16 Participants
Subjects with HFpEF will take a placebo daily
Placebo: Taken orally once a day, the placebo looks identical to the study drug but it contains no active ingredient
|
|---|---|---|
|
Change in Mean Pulmonary Arterial Pressure (PA) at Maximal Exercise
|
-5.2 mmHg
Standard Deviation 6.6
|
0.7 mmHg
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPulmonary Arterial (PA) pressure is a measure of cardiac filling pressure, measured using a high-fidelity micromanometer advanced through the lumen of a fluid-filled catheter during rest.
Outcome measures
| Measure |
Dapagliflozin Group
n=21 Participants
Subjects with HFpEF will take the study drug dapagliflozin daily
Dapagliflozin: 10 mg orally once a day
|
Placebo Group
n=16 Participants
Subjects with HFpEF will take a placebo daily
Placebo: Taken orally once a day, the placebo looks identical to the study drug but it contains no active ingredient
|
|---|---|---|
|
Change in Mean Pulmonary Arterial Pressure (PA) at Rest
|
-1.8 mmHg
Standard Deviation 4.0
|
1.1 mmHg
Standard Deviation 7.4
|
Adverse Events
Dapagliflozin Group
Serious events: 4 serious events
Other events: 21 other events
Deaths: 0 deaths
Placebo Group
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dapagliflozin Group
n=21 participants at risk
Subjects with HFpEF will take the study drug dapagliflozin daily
Dapagliflozin: 10 mg orally once a day
|
Placebo Group
n=17 participants at risk
Subjects with HFpEF will take a placebo daily
Placebo: Taken orally once a day, the placebo looks identical to the study drug but it contains no active ingredient
|
|---|---|---|
|
Surgical and medical procedures
humerus fracture
|
4.8%
1/21 • Number of events 1 • Adverse events were collected on each participant from enrollment through approximately one week following the final on-site study visit for a total of approximately seven months.
|
0.00%
0/17 • Adverse events were collected on each participant from enrollment through approximately one week following the final on-site study visit for a total of approximately seven months.
|
|
Infections and infestations
pneumonia related to COVID-19
|
4.8%
1/21 • Number of events 1 • Adverse events were collected on each participant from enrollment through approximately one week following the final on-site study visit for a total of approximately seven months.
|
0.00%
0/17 • Adverse events were collected on each participant from enrollment through approximately one week following the final on-site study visit for a total of approximately seven months.
|
|
General disorders
allergic food reaction
|
4.8%
1/21 • Number of events 1 • Adverse events were collected on each participant from enrollment through approximately one week following the final on-site study visit for a total of approximately seven months.
|
0.00%
0/17 • Adverse events were collected on each participant from enrollment through approximately one week following the final on-site study visit for a total of approximately seven months.
|
|
General disorders
hospitalization
|
4.8%
1/21 • Number of events 1 • Adverse events were collected on each participant from enrollment through approximately one week following the final on-site study visit for a total of approximately seven months.
|
0.00%
0/17 • Adverse events were collected on each participant from enrollment through approximately one week following the final on-site study visit for a total of approximately seven months.
|
Other adverse events
| Measure |
Dapagliflozin Group
n=21 participants at risk
Subjects with HFpEF will take the study drug dapagliflozin daily
Dapagliflozin: 10 mg orally once a day
|
Placebo Group
n=17 participants at risk
Subjects with HFpEF will take a placebo daily
Placebo: Taken orally once a day, the placebo looks identical to the study drug but it contains no active ingredient
|
|---|---|---|
|
General disorders
Minor bruising or bleeding following catheterization
|
9.5%
2/21 • Number of events 2 • Adverse events were collected on each participant from enrollment through approximately one week following the final on-site study visit for a total of approximately seven months.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected on each participant from enrollment through approximately one week following the final on-site study visit for a total of approximately seven months.
|
|
General disorders
Dizziness or dehydration
|
38.1%
8/21 • Number of events 8 • Adverse events were collected on each participant from enrollment through approximately one week following the final on-site study visit for a total of approximately seven months.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected on each participant from enrollment through approximately one week following the final on-site study visit for a total of approximately seven months.
|
|
Infections and infestations
Genitourinary infections
|
14.3%
3/21 • Number of events 3 • Adverse events were collected on each participant from enrollment through approximately one week following the final on-site study visit for a total of approximately seven months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected on each participant from enrollment through approximately one week following the final on-site study visit for a total of approximately seven months.
|
|
General disorders
Hypoglycemia
|
4.8%
1/21 • Number of events 1 • Adverse events were collected on each participant from enrollment through approximately one week following the final on-site study visit for a total of approximately seven months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected on each participant from enrollment through approximately one week following the final on-site study visit for a total of approximately seven months.
|
|
General disorders
Worsening dyspenea
|
28.6%
6/21 • Number of events 6 • Adverse events were collected on each participant from enrollment through approximately one week following the final on-site study visit for a total of approximately seven months.
|
41.2%
7/17 • Number of events 7 • Adverse events were collected on each participant from enrollment through approximately one week following the final on-site study visit for a total of approximately seven months.
|
|
General disorders
Worsening fatigue
|
14.3%
3/21 • Number of events 3 • Adverse events were collected on each participant from enrollment through approximately one week following the final on-site study visit for a total of approximately seven months.
|
23.5%
4/17 • Number of events 4 • Adverse events were collected on each participant from enrollment through approximately one week following the final on-site study visit for a total of approximately seven months.
|
|
General disorders
Medication intolerance
|
0.00%
0/21 • Adverse events were collected on each participant from enrollment through approximately one week following the final on-site study visit for a total of approximately seven months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected on each participant from enrollment through approximately one week following the final on-site study visit for a total of approximately seven months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place