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Thiazolidinedione

Pioglitazone for Heart Failure in Type 2 Diabetes (PIOHF Trial)

Phase 4
Recruiting
Led By Ralph DeFronzo, MD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Only T2D patients treated with diet/exercise, metformin, sulfonylurea, metformin/SU, DPP4i or insulin will be studied.
eGFR greater than 45 ml/min/1.73m²
Must not have
Subjects with history of osteoporosis or proliferative diabetic retinopathy
Subjects treated with a SGLT2i
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6-months post treatment (approximately 24 weeks)
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial tests if Pioglitazone can help type-2 diabetic obese patients with Heart failure by improving heart function and insulin sensitivity.

Who is the study for?
This trial is for obese individuals aged 30-70 with type-2 diabetes and heart failure (NYHA class II-III) who have an ejection fraction over 50%. Participants should be on certain diabetes medications but not on GLP-1 RA, thiazolidinedione, or SGLT2i. They must have stable heart medication use and no history of severe heart conditions unrelated to their diabetes.
What is being tested?
The study tests Pioglitazone's effect on heart function in diabetic patients with heart failure. It aims to see if the drug can improve energy production in the heart by reducing fat around it and increasing insulin sensitivity. Half will receive Pioglitazone; the other half a placebo.
What are the potential side effects?
Pioglitazone may cause fluid retention leading to swelling, weight gain, fatigue, bone fractures in women, bladder cancer risk increase after long-term use, and potential worsening of diabetic eye disease.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have type 2 diabetes and am treated with specific medications or diet/exercise.
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My kidney function is good.
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I am between 30 and 70 years old.
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I have moderate heart failure.
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My heart pumps well (EF > 50%).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of osteoporosis or diabetic eye disease.
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I have been treated with a medication for diabetes that belongs to the SGLT2 inhibitors class.
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I do not have heart failure or severe heart conditions.
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My heart failure medication has significantly changed in the last month.
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I am currently taking GLP-1 receptor agonists or thiazolidinediones.
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I have symptoms of heart disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6-months post treatment (approximately 24 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6-months post treatment (approximately 24 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Diastolic function
Change in Systolic function
Secondary study objectives
Myocardial fat content
Myocardial insulin sensitivity
PCr:ATP ratio

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Pioglitazone Administration GroupActive Control1 Intervention
Pioglitazone 15mg/day titrated to 30 mg/day at week 2 and to 45 mg/day at week 4
Group II: Placebo/Control GroupPlacebo Group1 Intervention
Placebo

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor
477 Previous Clinical Trials
92,892 Total Patients Enrolled
5 Trials studying Heart Failure
227 Patients Enrolled for Heart Failure
Ralph DeFronzo, MDPrincipal InvestigatorUniversity of Texas
11 Previous Clinical Trials
952 Total Patients Enrolled
2 Trials studying Heart Failure
101 Patients Enrolled for Heart Failure
Ralph A DeFronzo, MDPrincipal InvestigatorUniversity of Texas
9 Previous Clinical Trials
1,078 Total Patients Enrolled
1 Trials studying Heart Failure
78 Patients Enrolled for Heart Failure

Media Library

Pioglitazone (Thiazolidinedione) Clinical Trial Eligibility Overview. Trial Name: NCT05838287 — Phase 4
Heart Failure Research Study Groups: Pioglitazone Administration Group, Placebo/Control Group
Heart Failure Clinical Trial 2023: Pioglitazone Highlights & Side Effects. Trial Name: NCT05838287 — Phase 4
Pioglitazone (Thiazolidinedione) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05838287 — Phase 4
~52 spots leftby Apr 2028
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