Trial Outcomes & Findings for Ertugliflozin for Functional Mitral Regurgitation (NCT NCT04231331)

NCT ID: NCT04231331

Last Updated: 2025-01-06

Results Overview

Change of effective regurgitant orifice area (EROA) of functional mitral regurgitation

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 128 participants
• Primary outcome timeframe: Baseline and 12 months
• Results posted on: 2025-01-06

Participant Flow

Analyses followed the intention-to-treat principle, where all randomized patients were included in the group to which they were originally allocated.

Participant milestones

Measure	Placebo All patients will receive placebo in addition to their usual medications. Titration of HF medications should be completed and patients must take a stable, optimized dose of a β-blocker and an ACE inhibitor (or ARB) for at least 4 weeks prior to study entry. Placebo: Placebo qd for 12 months	Ertugliflozin All patients will receive ertugliflozin 5 mg qd in addition to their usual medications. Titration of HF medications should be completed and patients must take a stable, optimized dose of a β-blocker and an ACE inhibitor (or ARB) for at least 4 weeks prior to study entry. Ertugliflozin: Ertugliflozin 5mg qd for 12 months
Overall Study STARTED	65	63
Overall Study COMPLETED	56	58
Overall Study NOT COMPLETED	9	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Placebo n=65 Participants Placebo	Ertugliflozin n=63 Participants Ertugliflozin	Total n=128 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=65 Participants	0 Participants n=63 Participants	0 Participants n=128 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=65 Participants	50 Participants n=63 Participants	100 Participants n=128 Participants
Age, Categorical >=65 years	15 Participants n=65 Participants	13 Participants n=63 Participants	28 Participants n=128 Participants
Age, Continuous	67 years STANDARD_DEVIATION 11 • n=65 Participants	65 years STANDARD_DEVIATION 12 • n=63 Participants	66 years STANDARD_DEVIATION 11 • n=128 Participants
Sex: Female, Male Female	27 Participants n=65 Participants	23 Participants n=63 Participants	50 Participants n=128 Participants
Sex: Female, Male Male	38 Participants n=65 Participants	40 Participants n=63 Participants	78 Participants n=128 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Diabetes	9 Participants n=65 Participants	7 Participants n=63 Participants	16 Participants n=128 Participants
Atrial fibrillation	32 Participants n=65 Participants	33 Participants n=63 Participants	65 Participants n=128 Participants

PRIMARY outcome

Timeframe: Baseline and 12 months

Population: Primary analysis included all 114 patients who completed the study.

Change of effective regurgitant orifice area (EROA) of functional mitral regurgitation

Outcome measures

Measure	Placebo n=56 Participants Placebo	Ertugliflozin n=58 Participants Ertugliflozin
Change of EROA	0.03 square cm Standard Deviation 0.12	-0.05 square cm Standard Deviation 0.06

SECONDARY outcome

Timeframe: Baseline and 12 months

Change of regurgitant volume of functional mitral regurgitation

Outcome measures

Measure	Placebo n=56 Participants Placebo	Ertugliflozin n=58 Participants Ertugliflozin
Change of Regurgitant Volume	39.3 mL Standard Deviation 31.1	24.6 mL Standard Deviation 14.3

SECONDARY outcome

Timeframe: Baseline and 12 months

Left ventricular end-systolic volume was measured with the use of echocardiography. Left ventricular end-systolic volume index was obtained by dividing end-systolic volume by body surface area.

Outcome measures

Measure	Placebo n=56 Participants Placebo	Ertugliflozin n=58 Participants Ertugliflozin
Change of End-systolic Volume Index	-3.6 mL/square m Standard Deviation 13.4	-4.1 mL/square m Standard Deviation 8.1

SECONDARY outcome

Timeframe: Baseline and 12 months

Left ventricular end-diastolic volume was measured with the use of echocardiography. Left ventricular end-diastolic volume index was obtained by dividing end-diastolic volume by body surface area.

Outcome measures

Measure	Placebo n=56 Participants Placebo	Ertugliflozin n=58 Participants Ertugliflozin
Change of End-diastolic Volume Index	-5.7 mL/square m Standard Deviation 17.2	-4.7 mL/square m Standard Deviation 11.0

SECONDARY outcome

Timeframe: Baseline and 12 months

Change of NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)

Outcome measures

Measure	Placebo n=56 Participants Placebo	Ertugliflozin n=58 Participants Ertugliflozin
Change of NT-proBNP	126 pg/mL Standard Deviation 1112	-154 pg/mL Standard Deviation 815

SECONDARY outcome

Timeframe: Baseline and 12 months

Myocardial strain is a measure of percenage shortening of myocardium. Myocardial strain measurement was performed with a semiautomated alogithm using speckle-tracking echocardiogrphy. Measurements of eft ventricular global longitudinal strain were made in the 3 standard apical views and averaged.

Outcome measures

Measure	Placebo n=56 Participants Placebo	Ertugliflozin n=58 Participants Ertugliflozin
Change of Left Ventricular Global Longitudinal Strain	0.10 percent change of myocardial length Standard Deviation 2.68	-1.34 percent change of myocardial length Standard Deviation 2.57

SECONDARY outcome

Timeframe: Baseline and 12 months

Left atrial end-systolic volume was measured with the use of echocardiography. Left atrial end-systolic volume index was obtained by dividing end-systolic volume by body surface area.

Outcome measures

Measure	Placebo n=56 Participants Placebo	Ertugliflozin n=58 Participants Ertugliflozin
Change of LA End-systolic Volume Index	3.2 mL/square m Standard Deviation 17.7	-2.8 mL/square m Standard Deviation 13.8

Adverse Events

Placebo

Serious events: 3 serious events

Other events: 0 other events

Deaths: 3 deaths

Ertugliflozin

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=65 participants at risk Placebo	Ertugliflozin n=63 participants at risk Ertugliflozin
Cardiac disorders Heart failure hospitalization	4.6% 3/65 • Number of events 3 • 12 months	1.6% 1/63 • Number of events 1 • 12 months

Other adverse events

Measure	Placebo n=65 participants at risk Placebo	Ertugliflozin n=63 participants at risk Ertugliflozin
Cardiac disorders Heart failure hospitalization	0.00% 0/65 • 12 months	0.00% 0/63 • 12 months

Additional Information

Professor Duk-Hyun Kang

Asan Medical Center

Phone: 821030103166

Email: dhkang@amc.seoul.kr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place