All > Heart Failure With Preserved Ejection Fraction > Pulmonary Hypertension

Metformin for Pulmonary Hypertension

UCSF Medical Center, San Francisco, CA
Pulmonary Hypertension+1 More ConditionsMetformin - Drug
Eligibility
18+
All Sexes

Study 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.

Eligible Conditions
  • Pulmonary Hypertension
  • Heart Failure

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Similar Trials

1
Metformin
1
Metformin
1
Insulin

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 12 weeks (i.e. the 12th week of placebo vs 12th week of metformin)

Week 12
Metformin

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

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1
Metformin
2
Metformin
2
Insulin

Side Effects for

Vildagliptin (LAF237)
13%Nasopharyngitis
10%Hyperhidrosis
9%Tremor
9%Hunger
8%Asthenia
6%Hypoglycaemia
1%Squamous cell carcinoma of the tongue
1%Femoral neck fracture
This histogram enumerates side effects from a completed 2015 Phase 4 trial (NCT02002221) in the Vildagliptin (LAF237) ARM group. Side effects include: Nasopharyngitis with 13%, Hyperhidrosis with 10%, Tremor with 9%, Hunger with 9%, Asthenia with 8%.

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.

Trial Design

2 Treatment Groups

Drug: Metformin
1 of 2
Placebo Oral Capsule
1 of 2

Experimental Treatment

Non-Treatment Group

10 Total Participants · 2 Treatment Groups

Primary Treatment: Metformin · Has Placebo Group · Phase 2

Drug: Metformin
Drug
Experimental Group · 1 Intervention: Metformin · Intervention Types: Drug
Placebo Oral Capsule
Drug
PlaceboComparator Group · 1 Intervention: Placebo oral capsule · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks (i.e. the 12th week of placebo vs 12th week of metformin)

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,487 Previous Clinical Trials
5,129,738 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,347 Previous Clinical Trials
11,783,102 Total Patients Enrolled
Michael Risbano, MD, MAPrincipal InvestigatorUniversity of Pittsburgh
1 Previous Clinical Trials
21 Total Patients Enrolled
Marc A Simon, MD, MSStudy DirectorUniversity of California, San Francisco

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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