Cardiometabolic Disease and Pulmonary Hypertension
| Status: | Recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), High Blood Pressure (Hypertension), Obesity Weight Loss |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
| Healthy: | No |
| Age Range: | 30 - 80 |
| Updated: | 10/31/2018 |
| Start Date: | November 27, 2017 |
| End Date: | September 1, 2024 |
| Contact: | Elizabeth Liu, BS |
| Email: | ELIU9@MGH.HARVARD.EDU |
| Phone: | 617-724-3064 |
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.
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.
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.
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.
Inclusion Criteria:
- Age 30-80 years
- BMI ≥ 30 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
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Phone: 617-724-3064
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