Trial Outcomes & Findings for A Pilot Study: Metformin Therapy in Heart Failure Patients With Early Diabetes or at High Risk of Developing Diabetes (Pre-Diabetes) (NCT NCT01573949)

Results Overview

HRQoL as assessed by the Minnesota Living With Heart Failure Questionnaire (MLHFQ) The MLHFQ is a self-administered questionnaire for patients with HF, comprising 21 items rated on six-point Likert scales, representing different degrees of impact of HF on HRQoL, from 0 (none) to 5 (very much). It provides a total score range 0-105. Lower scores indicate better health-related quality of life (HRQoL).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

7 participants

Primary outcome timeframe

3 months

Results posted on

2020-09-04

Participant Flow

Participant milestones

Participant milestones
Measure	Metformin Metformin at 500 mg PO BID and pending lab values may have been titrated to 1000 mg PO BID at 1 month.
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Metformin n=7 Participants Metformin at 500 mg PO BID and pending lab values may have been titrated to 1000 mg PO BID at 1 month.
Age, Continuous	59 years STANDARD_DEVIATION 8 • n=7 Participants
Sex: Female, Male Female	1 Participants n=7 Participants
Sex: Female, Male Male	6 Participants n=7 Participants
Region of Enrollment United States	7 Participants n=7 Participants

PRIMARY outcome

Timeframe: 3 months

HRQoL as assessed by the Minnesota Living With Heart Failure Questionnaire (MLHFQ) The MLHFQ is a self-administered questionnaire for patients with HF, comprising 21 items rated on six-point Likert scales, representing different degrees of impact of HF on HRQoL, from 0 (none) to 5 (very much). It provides a total score range 0-105. Lower scores indicate better health-related quality of life (HRQoL).

Outcome measures

Outcome measures
Measure	Metformin n=7 Participants Metformin at 500 mg PO BID and pending lab values may have been titrated to 1000 mg PO BID at 1 month.
Health-Related Quality of Life (HRQoL) Baseline	37 score on a scale Interval 1.0 to 91.0
Health-Related Quality of Life (HRQoL) Three Months	37 score on a scale Interval 6.0 to 86.0

SECONDARY outcome

Timeframe: 3 months

The HbA1c test measures how much glucose is bound to hemoglobin in the red blood cells. The test shows the average level of glucose in blood for the past 3 months (the average lifespan of red blood cells). If glucose levels have been high over recent weeks, the hemoglobin A1c test will be higher.

Outcome measures

Outcome measures
Measure	Metformin n=7 Participants Metformin at 500 mg PO BID and pending lab values may have been titrated to 1000 mg PO BID at 1 month.
Glycated Hemoglobin (HbA1c) Baseline	6.1 percentage of glycated hemoglobin Standard Deviation 0.4
Glycated Hemoglobin (HbA1c) Three Months	6.2 percentage of glycated hemoglobin Standard Deviation 0.4

SECONDARY outcome

Timeframe: 3 months

Obtained from Echocardiography

Outcome measures

Outcome measures
Measure	Metformin n=7 Participants Metformin at 500 mg PO BID and pending lab values may have been titrated to 1000 mg PO BID at 1 month.
Left Ventricular Ejection Fraction (LVEF) Baseline	25 percent ejection fraction Standard Deviation 8
Left Ventricular Ejection Fraction (LVEF) Three Months	26 percent ejection fraction Standard Deviation 9

SECONDARY outcome

Timeframe: 3 months

Serum creatinine

Outcome measures

Outcome measures
Measure	Metformin n=7 Participants Metformin at 500 mg PO BID and pending lab values may have been titrated to 1000 mg PO BID at 1 month.
Creatinine Level as a Measure of Renal Function Baseline	1.1 mg/dL Standard Deviation 0.2
Creatinine Level as a Measure of Renal Function Three Months	1.1 mg/dL Standard Deviation 0.2

Adverse Events

Metformin

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

Tamara Horwich, MD, MS

University of California Los Angeles

Phone: 310-825-8816

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place