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Clinical trial

Evaluation of the Cardiac and Metabolic Effects of Dapagliflozin in Heart Failure With Preserved Ejection Fraction (CAMEO-DAPA): A Phase II, Prospective, Double-Blind Study

ID
Name
20-005646
Description
The purpose of this study is to determine whether treatment with Dapagliflozin (DAPA) for 6 months will improve pulmonary capillary wedge pressure (PCWP) during exercise in heart failure/preserved ejection fraction (HFpEF) and improve cardiac metabolism.
Trial arms
Trial start
2021-02-24
Estimated PCD
2022-11-17
Trial end
2022-11-17
Status
Completed
Phase
Early phase I
Treatment
Dapagliflozin
10 mg orally once a day
Arms:
Dapagliflozin Group
Placebo
Taken orally once a day, the placebo looks identical to the study drug but it contains no active ingredient
Arms:
Placebo Group
Size
38
Primary endpoint
Pulmonary Capillary Wedge Pressure (PCWP) at Maximal Exercise
Baseline, 24 weeks
Pulmonary Capillary Wedge Pressure (PCWP) at Rest
Baseline, 24 weeks
Eligibility criteria
Inclusion Criteria: * Signed informed consent prior to any study specific procedures. * Male or female. * Symptoms of dyspnea (NYHA II-III) with no non-cardiac or ischemia explanation. * EF ≥ 50% + BMI ≥ 30 kg/m\^2 * Elevated pulmonary capillary wedge pressure (PCWP) during exercise (≥ 25 mmHg) ascertained at Visit 1. Patients that have consented to study procedures but do not meet this invasive criterion will be considered as screen failures and will not be randomized . Exclusion Criteria: * Type I diabetes. * Type II diabetes with poor control (HgbA1C ≥ 10%). * Recent hospitalization (\< 30 days) or revascularization (\< 90 days). * Primary cardiomyopathy (such as amyloid). * Constrictive pericarditis. * Dyspnea due to primary lung disease or myocardial ischemia in the opinion of the investigator. * Severe anemia (hemoglobin \< 9gm/dl. * Significant left-sided valvular heart disease (\> mild stenosis, \> moderate regurgitation), * Severe kidney disease (estimated glomerular filtration rate (GFR) \< 30) or liver disease,
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 38, 'type': 'ACTUAL'}}
Updated at
2023-10-12

1 organization

2 drugs

1 indication

Organization
Mayo Clinic
Drug
Dapagliflozin
Indication
Heart Failure with Preserved Ejection Fraction
Drug
Varlilumab