Trial Outcomes & Findings for Management of Diabetes With Metformin In Patients With Chronic Heart Failure (NCT NCT01122316)

NCT ID: NCT01122316

Last Updated: 2020-09-04

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: 10 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2020-09-04

Participant Flow

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	10
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Metformin n=10 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	52.5 years STANDARD_DEVIATION 10 • n=10 Participants
Sex: Female, Male Female	2 Participants n=10 Participants
Sex: Female, Male Male	8 Participants n=10 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Analysis includes participants who completed intervention and final study assessment

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

Measure	Metformin n=8 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	56 score on a scale Standard Deviation 25
Health-Related Quality of Life (HRQoL) Three Months	53 score on a scale Standard Deviation 35

SECONDARY outcome

Timeframe: 3 months

Population: Analysis includes participants who completed intervention and final study assessment

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

Measure	Metformin n=8 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	9.1 percentage of glycated hemoglobin Standard Deviation 2.3
Glycated Hemoglobin (HbA1c) Three Months	8.9 percentage of glycated hemoglobin Standard Deviation 3.0

SECONDARY outcome

Timeframe: 3 months

Population: Analysis includes participants who completed intervention and final study assessment

Obtained from Echocardiography

Outcome measures

Measure	Metformin n=8 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	22 percent ejection fraction Standard Deviation 11
Left Ventricular Ejection Fraction (LVEF) Three Months	28 percent ejection fraction Standard Deviation 11

SECONDARY outcome

Timeframe: 3 months

Population: Analysis includes participants who completed intervention and final study assessment

Serum creatinine

Outcome measures

Measure	Metformin n=8 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	1.04 mg/dL Standard Deviation 0.18
Creatinine Level as a Measure of Renal Function Three Months	1.09 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: thorwich@mednet.ucla.edu

Results disclosure agreements

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