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Biguanide

Metformin for Pulmonary Hypertension (PH-HFpEF Trial)

Phase 2

Recruiting

Led By Michael Risbano, MD, MA

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks (i.e. the 12th week of placebo vs 12th week of metformin)

Awards & highlights

PH-HFpEF Trial Summary

This trial is testing whether the diabetes drug metformin can improve outcomes in people with PH-HFpEF. The study will look at how well metformin works compared to placebo and what the effects are on heart function and capacity.

Who is the study for?

This trial is for adults with PH-HFpEF, a type of heart failure with high blood pressure in the lungs. Participants must have been diagnosed within the last 6 months and show at least three signs of metabolic syndrome. People under 18, those with uncontrolled hypertension or very low blood pressure, severe diabetes, recent major heart events, certain chronic diseases, or who are pregnant/breastfeeding cannot join.Check my eligibility

What is being tested?

The study aims to see if Metformin can improve how well the heart and lungs work in people with PH-HFpEF compared to a placebo (a pill without any medicine). Patients will be randomly assigned to either receive Metformin or the placebo while their functional capacity and hemodynamics (blood flow) are monitored.See study design

What are the potential side effects?

Metformin may cause side effects like stomach upset, diarrhea, muscle pain, low vitamin B12 levels, and rarely lactic acidosis (a buildup of lactate in the body), which is serious but uncommon.

PH-HFpEF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks (i.e. the 12th week of placebo vs 12th week of metformin)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks (i.e. the 12th week of placebo vs 12th week of metformin)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks (i.e. the 12th week of placebo vs 12th week of metformin) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Metformin

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221

13%

Nasopharyngitis

10%

Hyperhidrosis

Hunger

Tremor

Asthenia

Hypoglycaemia

Femoral neck fracture

Squamous cell carcinoma of the tongue

100%

80%

60%

40%

20%

Study treatment Arm

Vildagliptin (LAF237)

Placebo

PH-HFpEF Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Drug: MetforminExperimental Treatment1 Intervention

500mg PO (by mouth) BID (two times daily) x 1 week then increase to 1000mg PO BID x 11 weeks

Group II: Placebo Oral CapsulePlacebo Group1 Intervention

Placebo capsule that is of identical size, shape, and color to experimental drug capsule PO (by mouth) BID (two times each day) for 12 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Metformin

2006

Completed Phase 4

~2430

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH

1,672 Previous Clinical Trials

28,018,653 Total Patients Enrolled

University of California, San FranciscoLead Sponsor

2,505 Previous Clinical Trials

15,237,545 Total Patients Enrolled

Marc A Simon, MD, MSStudy DirectorUniversity of California, San Francisco

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA cleared Metformin for general use?

"Metformin is a medication that, according to our assessment, ranks as a 2 in terms of safety. This is due to it being in Phase 2 trials meaning while there is evidence suggesting it is safe, there is no data yet affirming its efficacy."

Answered by AI

How many people fit the requirements to enroll in this experiment?

"That is correct. The clinical trial in question, which was first posted on February 26th 2019 and updated most recently on December 17th 2021, is currently seeking enrolment from 10 patients at 2 locations."

Answered by AI

Are there any other ongoing investigations that include Metformin?

"Currently, 179 clinical trials involving Metformin are ongoing with 44 of those in the final stage. Many trials are based in Pittsburgh, but there are 1951 locations conducting research on this medication."

Answered by AI

Are we still accepting participants for this experiment?

"That is correct. The clinicaltrials.gov website provides information which indicates that this study is still recruiting individuals. This trial was initially posted on February 26th, 2019 and updated December 17th, 2021. There are currently 10 patients enrolled at 2 locations."

Answered by AI

What are the primary conditions that Metformin is indicated to treat?

"Metformin is a medication with many potential applications. It is commonly used to treat exercise, but it can also help manage type 1 diabetes mellitus, diabetic ketoacidosis, and polycystic ovary syndrome."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Metformin for Pulmonary Hypertension HFpEF

2019. "Metformin for Pulmonary Hypertension HFpEF". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03629340.

All > Heart Failure With Preserved Ejection Fraction > Pulmonary Hypertension