Cardiometabolic Disease and Pulmonary Hypertension

Study Purpose

This study will investigate if metformin can help people with obesity and high pressures inside their lung blood vessels. Metformin is approved by the U.S. Food and Drug Administration (FDA) to treat diabetes, but metformin is not approved by the FDA to treat pulmonary hypertension. This study will examine whether Metformin will improve the high pressure inside lung blood vessels in people who are obese. The study will help understand the effect of metformin on pressures inside lung blood vessels.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 30 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Age 30-80 years.
  • - History of obesity and current BMI ≥ 25 kg/ m2 for study volunteers or BMI ≥ 25 kg/ m2 for those with clinically indicated CPET or known HFpEF.
  • - History of Dyspnea (Grade 1 or more) - Able to provide informed consent and willing to comply with study.

Exclusion Criteria:

  • - History of diabetes mellitus.
  • - History of primary pulmonary arterial hypertension.
  • - History of moderate to severe COPD.
  • - History of severe Obstructive Sleep apnea.
  • - History of renal disease (eGFR< 45 mL/min/1.732) - History of severe liver disease.
  • - History of cardiovascular disease (recent heart attack or stroke) except known HFpEF.
  • - History of blood clot in lung.
  • - History of Splenectomy.
  • - History of Active Cancer.
  • - Platelets count of < 75,000.
  • - International normalized ration (INR) of > 1.5.
  • - History of recent anemia (HB < 9g/dL) - Current use of Metformin.
  • - Prior LVEF < 50% on echocardiogram.
  • - Indication of severe valvular disease on echo.
  • - Pregnant or planning to become pregnant in next 4 months.
- History of HIV infection

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03349775
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Massachusetts General Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jennifer E Ho, MD
Principal Investigator Affiliation Massachusetts General Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Obesity
Additional Details

Obesity can predispose people to develop high pressures inside their lung blood vessels, a condition called pulmonary hypertension, Pulmonary hypertension in turn, can lead to shortness of breath and other health complications such as heart failure. In this study, we seek to identify individuals at risk for the development of high pressures inside lung vessels based on BMI and dyspnea grade 1. Participants will be screened by echocardiography to estimate pulmonary pressures. Potential participants will undergo invasive cardiopulmonary exercise testing with hemodynamic monitoring, in order to identify individuals with abnormal pulmonary vascular function either at rest or during exercise. Patients who have undergone clinically-indicated cardiopulmonary exercise testing and meet inclusion/exclusion criteria will also be recruited. Those with abnormal pulmonary vascular function will be randomized to receive Metformin or placebo for a total of 3 months under an IND exemption. The primary outcomes include the effect on pulmonary vascular function at rest and during exercise. Secondary outcomes include change in pulmonary artery endothelial cell phenotypes.

Arms & Interventions

Arms

Active Comparator: Metformin

Metformin: 500mg twice daily for 1 week, followed by 1g twice daily for a total of 3 months.

Placebo Comparator: Placebo

Placebo: 500 mgh twice daily for 1 week, followed by 1g twice daily for a total of 3 months.

Interventions

Drug: - Metformin

One capsule by mouth twice a day, followed by an increase to two capsules by mouth twice a day for a total of 3 months

Drug: - Placebo

One capsule by mouth twice a day, followed by an increase to two capsules by mouth twice a day for a total of 3 months

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Massachusetts General Hospital, Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Site Contact

Elizabeth Liu, BS

ELIU9@MGH.HARVARD.EDU

617-724-3064

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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