ACTIVE_NOT_RECRUITING

Metformin for Older Patients With Heart Failure With Preserved Ejection Fraction

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Conditions

Heart Failure With Preserved Ejection Fractionheart failure, metformin, inflammation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Met-PEF will be a randomized, double-blind, placebo-controlled trial to examine the effects of 20 weeks of 1500 mg/day of metformin on physical function, quality of life (QOL), microbiome diversity, leaky gut, and systemic inflammation in patients with 86 older patients with heart failure with preserved ejection fraction (HFpEF).

Official Title

Metformin for Older Patients With Heart Failure With Preserved Ejection Fraction

Quick Facts

Study Start:2022-01-04
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05093959

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Heart failure with preserved ejection fraction (HFpEF) will be defined in accord with the American College of Cardiology/American Heart Association 2013 guidelines statement on Management of heart failure and as previously described. The 4 key inclusion criteria for HFpEF include: 1) clinical signs and symptoms as scored by National Health and Nutrition Examination Survey (NHANES)-HF Clinical Score ≥3 and the Rich Criteria; 2) a normal left ventricular (LV) ejection fraction (≥50%) by echocardiography; 3) LV diastolic dysfunction \> grade 1 (American Society of Echocardiography Recommendations); 4) no evidence of significant ischemic, valvular, pulmonary or other medical disorder to account for their symptoms.
  2. * Age ≥60
  3. * Stable HF symptoms and medications for ≥3 weeks
  4. * Final eligibility will be based upon all information available at the conclusion of the baseline visits tests, including review of hospital and outpatient records, history, physical examination, echocardiogram, and familiarization/screening exercise test by a board-certified investigator cardiologist who have extensive experience in heart failure investigations in older persons with HFpEF
  1. * History of treatment with metformin or other anti-diabetic drug intended to treat diabetes
  2. * Body mass index (BMI) \<25.0
  3. * Uncontrolled dysrhythmia
  4. * Uncontrolled hypertension (systolic blood pressure \[SPB\]\>200 mmHg or diastolic blood pressure \[DBP\]\>100 mmHg at rest)
  5. * Significant anemia (\<9.5 g hemoglobin \[Hb\]) (eligibility will be determined by complete blood count)
  6. * Significant renal insufficiency (estimated glomerular filtration rate \[eGFR\] \<45 ml/min/1.73 m2) (eligibility will be determined by comprehensive metabolic panel)
  7. * Acute or chronic metabolic acidosis
  8. * Type 2 diabetes, or HbA1c\>6.5
  9. * Low vitamin B12 (\<232 pg/mL)
  10. * Known valvular heart disease, infiltrative cardiomyopathy, or hypertrophic obstructive cardiomyopathy with active obstruction as the primary etiology of HF
  11. * Evidence of significant chronic obstructive pulmonary disease (COPD) defined as either: a. On continuous home oxygen therapy for COPD; b. Hospitalization for COPD in last 6 months
  12. * Any condition that in the judgement of the investigator precludes participation in study or study procedures such as significant dementia, mobility impairment, uncontrolled psychiatric disease, etc.
  13. * Alcohol abuse (\>14 drinks/week)
  14. * Current or recent cancer, or chemotherapy/radiation treatment
  15. * Pregnancy-women of child-bearing potential are excluded from participation in this study.
  16. * A treadmill exercise test revealing: a. Evidence of significant ischemia; b. Electrocardiogram: 1mm flat ST depression; c. Stopped exercising due to chest or leg claudication or any reason other than exhaustion/fatigue/dyspnea; d. Exercise SBP \> 240 mmHg, DBP \> 110 mmHg ; e. Unstable hemodynamics or rhythm; f. Unwilling or unable to complete adequate exercise test
  17. * Exclusions for microbiome testing: a. Antibiotics use within last 30 days; b. Diarrhea and/or vomiting within last 30 days; c. Surgery related to gut in last 6 months; d. Inflammatory bowel disease (such as Crohn's disease or ulcerative colitis), or irritable bowel syndrome
  18. * Plans to leave area within 1 year
  19. * Currently participating in other investigational study
  20. * Refuses informed consent

Contacts and Locations

Principal Investigator

Dalane W. Kitzman, MD
PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences

Study Locations (Sites)

Atrium Health Sanger Heart and Vascular Clinic Institute
Charlotte, North Carolina, 28203
United States
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • Dalane W. Kitzman, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-04
Study Completion Date2025-12

Study Record Updates

Study Start Date2022-01-04
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • heart failure, metformin, inflammation

Additional Relevant MeSH Terms

  • Heart Failure With Preserved Ejection Fraction