Status:
TERMINATED
Cardiometabolic Disease and Pulmonary Hypertension
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Obesity
Eligibility:
All Genders
30-80 years
Phase:
EARLY_PHASE1
Brief 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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2020
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03349775
Start Date
November 27 2017
End Date
December 22 2020
Last Update
January 21 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114