Cardiometabolic Disease and Pulmonary Hypertension

• Status: Terminated
• Trial end date: 2020-12-22
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Metformin

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