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Metformin for PH+HFpEF

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ClinicalTrials.gov Identifier: NCT03629340
Recruitment Status : Recruiting
First Posted : August 14, 2018
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Marc A. Simon, University of Pittsburgh

Brief Summary:
The main objective of this study is to determine the clinical efficacy of metformin versus placebo and the therapeutic response with regards to functional capacity and hemodynamics in PH-HFpEF.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Heart Failure Drug: Metformin Drug: Placebo oral capsule Phase 2

Detailed Description:
This is a 12-week blinded cross over trial of metformin in PH-HFpEF to improve exercise hemodynamics, functional capacity, and glucose metabolism. This phase II clinical trial will provide detailed phenotyping, physiological and mechanistic data on PH-HFpEF.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Trial of Metformin for Pulmonary Hypertension in Heart Failure With Preserved Ejection Fraction
Actual Study Start Date : February 26, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Drug: Metformin
500mg PO (by mouth) BID (two times daily) x 1 week then increase to 1000mg PO BID x 11 weeks
Drug: Metformin
500 mg PO BID x 1 week then increase to 1000 mg PO BID x 11 weeks

Placebo Comparator: Placebo Oral Capsule
Placebo capsule that is of identical size, shape, and color to experimental drug capsule PO (by mouth) BID (two times each day) for 12 weeks
Drug: Placebo oral capsule
Placebo capsule that is of identical size, shape, and color to experimental drug capsule PO (by mouth) BID (two times each day) for 12 weeks




Primary Outcome Measures :
  1. The primary endpoint of the trial will be mean pulmonary artery pressure (mPAP) during submaximal exercise as compared between placebo and metformin at 12 weeks (i.e. the week 12 RHC of placebo vs week 12 RHC of metformin). [ Time Frame: 12 weeks (i.e. the 12th week of placebo vs 12th week of metformin) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

2. PH-HFpEF Confirmed diagnosis by RHC within the past 6 months:

Mean Pulmonary Arterial Pressure (mPAP) ≥ 25 mm Hg AND Pulmonary artery wedge pressure (PAWP) ≥ 15 mm Hg AND Transpulmonary Gradient (TPG) ≥ 12 mm Hg

OR Exercise measurements

Mean Pulmonary Arterial Pressure (mPAP) ≥ 30 mm Hg AND Pulmonary artery wedge pressure (PAWP) ≥ 20 mm Hg AND PA calculation (change in mPAP/change in cardiac output) = ≥3 mmHg/L/min

3. Three or more features of metabolic syndrome defined as:

Body Mass Index (BMI) ≥ 30 kg/m² Systolic blood pressure (BP) ≥ 130 mm Hg and/or diastolic BP ≥ 85 mm Hg Elevated waist circumference > 102 cm in men and > 88 cm in women Fasting triglyceride (TG) level over 150 mg/dl High-density lipoprotein <40 mg/dL in men or < 50 mg/dL in women

Exclusion Criteria:

  1. Age less than 18 years;
  2. Uncontrolled systemic hypertension based on repeated measurement of sitting systolic blood pressure >170 mm Hg or sitting diastolic blood pressure >95 mm Hg at Screening;
  3. Systemic sitting blood pressure < 110 mmHg systolic or < 60 mm Hg diastolic at Screening;
  4. Hemoglobin A1C > 10;
  5. Currently taking metformin or history of intolerance to metformin or contraindication to taking metformin;
  6. Known type 1 diabetes
  7. Positive urine pregnancy test or breastfeeding
  8. Ejection Fraction < 50%
  9. Dementia;

11. End-stage malignancy; 12. Major cardiovascular event or procedure within 6 weeks prior to enrollment; 13. Severe valvular disease; 14. Other severe acute or chronic medical, psychiatric or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study or would prevent completion of the study; 15. Current Smoker; 16. Hemoglobin <9 g/dL; 17. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2; 18. Receipt of an investigational product or device, or participation in a drug research study within a period of 15 days 19. <3 months of stable dose of PDE5i


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03629340


Contacts
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Contact: Sara Onesi, RN 412-864-3265 onesisa@upmc.edu
Contact: Nicole Helbling, MS, BSN, RN 412-692-2285 helblingnl@upmc.edu

Locations
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United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Sara Onesi, RN    412-864-3265    onesisa@upmc.edu   
Principal Investigator: Marc Simon, MD         
Sponsors and Collaborators
Marc A. Simon
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Marc Simon, MD, MS, FACC University of Pittsburgh

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Responsible Party: Marc A. Simon, Associate Professor of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03629340     History of Changes
Other Study ID Numbers: PRO18030354
R01AG058659 ( U.S. NIH Grant/Contract )
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Hypertension
Heart Failure
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Lung Diseases
Respiratory Tract Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs