Heart Failure With Preserved Ejection Fraction Clinical Trial
Official title:
Metformin for Older Patients With Heart Failure With Preserved Ejection Fraction
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 80 older patients with heart failure with preserved ejection fraction (HFpEF).
Enrollment of participants will be conducted at both Wake Forest and Atrium Health (approximately 40 participants at each site) following assessment of eligibility criteria and willingness to participate in the trial. Eligibility criteria are designed to target the population under study and exclude participants unable to safely take the study intervention or undergo study procedures. Informed consent will be obtained from qualified participants. Participants will complete baseline assessments before masked, random assignment to metformin or placebo. The assigned study medications will be dispensed by the research pharmacy. Participants will take assigned metformin or placebo for a treatment period of 20 weeks, starting at 500mg/day and escalating over the first 3 weeks to a target dose of 1500mg/day. Participants will be contacted every 2 weeks for assessment of adverse events, side effects, and adherence. At week 4, participants will be seen in clinic for safety laboratory assessments. At week 20, participants will complete follow-up assessments by an assessor blinded to treatment group. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Suspended |
NCT05839730 -
Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
|
N/A | |
Recruiting |
NCT05095688 -
Relationship Between Adipose Tissue Distribution and Arterial Stiffness in HFpEF
|
||
Recruiting |
NCT06379152 -
Effect of Bilirubin on Prognosis in Heart Failure With Preserved Ejection Fraction
|
||
Recruiting |
NCT05676684 -
Dapagliflozin, Spironolactone or Both for HFpEF
|
Phase 2/Phase 3 | |
Recruiting |
NCT04153136 -
Effects of Sacubitril/Valsartan on Subclinical Heart Failure in HIV (The ENCHANTMENT HIV Study)
|
Phase 2 | |
Recruiting |
NCT06114498 -
Hospital Register of Decompensated Heart Failure With Preserved Ejection Fraction
|
||
Recruiting |
NCT05715697 -
Renal Denervation in Patients With Chronic Heart Failure With Preserved Ejection Fraction
|
N/A | |
Recruiting |
NCT04745013 -
PeRsonalIzed remOtely Guided Preventive exeRcIse Therapy for a healThY Heart
|
N/A | |
Completed |
NCT05126836 -
Cilostazol for HFpEF
|
Phase 2 | |
Completed |
NCT05586828 -
A Single-center Retrospective Cohort Study to Explore the Prognostic Significance of CONUT in Elderly CAD Patients With HFpEFand Compare CONUT With Other Objective Nutritional Indices.
|
||
Recruiting |
NCT04594499 -
The Relationship Between Pericardial Fat Thickness and Arterial Stiffness in HFpEF Patients
|
||
Active, not recruiting |
NCT05204238 -
Follow Up of acuTe Heart failUre: a pRospective Echocardiographic and Clinical Study (FUTURE)
|
||
Completed |
NCT04535726 -
The Relationship Between Blood Pressure and Arterial Stiffness in HFpEF Patients With Different Levels of Obesity
|
||
Recruiting |
NCT03550235 -
Exploration of Dyspnea at Non-high Brain Natriuretic Peptide (BNP)
|
||
Completed |
NCT04633460 -
Acute Effects of Exogenous Ketone Ester Administration in Heart Failure
|
Phase 2 | |
Completed |
NCT06228807 -
Clinical Characteristics and Predictors of Adverse Outcomes in HFpEF
|
||
Active, not recruiting |
NCT05284617 -
Exploratory Ph 2A, Double-Blind, Placebo-Controlled Dose Escalation Study of Safety, Tolerability, PD, & PK of HU6 for Subjects With Obese HFpEF
|
Phase 2 | |
Recruiting |
NCT05562063 -
Sotagliflozin in Heart Failure With Preserved Ejection Fraction (HFpEF) Patients
|
Phase 4 | |
Recruiting |
NCT06027307 -
Enavogliflozin Outcome Trial in Functional Tricuspid Regurgitation
|
Phase 3 | |
Recruiting |
NCT05582044 -
Exercise Lower-body Negative Pressure in Heart Failure With Preserved Ejection Fraction
|
N/A |