Dapagliflozin (DAPA) Effects in HFpEF
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
1 other identifier
interventional
38
1 country
1
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2021
CompletedFirst Posted
Study publicly available on registry
January 29, 2021
CompletedStudy Start
First participant enrolled
February 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 17, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 17, 2022
CompletedResults Posted
Study results publicly available
October 12, 2023
CompletedOctober 12, 2023
September 1, 2023
1.7 years
January 27, 2021
September 20, 2023
September 20, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Pulmonary Capillary Wedge Pressure (PCWP) at Maximal Exercise
Pulmonary capillary wedge pressure is a measure of cardiac filling pressure, measured using a high-fidelity micromanometer advanced through the lumen of a fluid-filled catheter during exercise.
Baseline, 24 weeks
Pulmonary Capillary Wedge Pressure (PCWP) at Rest
Pulmonary capillary wedge pressure is a measure of cardiac filling pressure, measured using a high-fidelity micromanometer advanced through the lumen of a fluid-filled catheter during rest.
Baseline, 24 weeks
Secondary Outcomes (7)
Change in Body Weight
Baseline, 24 weeks
Change in Total Blood Volume
Baseline, 24 weeks
Change in Plasma Volume
Baseline, 24 weeks
Change in Right Atrial (RA) Pressure at Maximal Exercise
Baseline, 24 weeks
Change in Right Atrial (RA) Pressure at Rest
Baseline, 24 weeks
- +2 more secondary outcomes
Study Arms (2)
Dapagliflozin Group
EXPERIMENTALSubjects with HFpEF will take the study drug dapagliflozin daily
Placebo Group
PLACEBO COMPARATORSubjects with HFpEF will take a placebo daily
Interventions
Taken orally once a day, the placebo looks identical to the study drug but it contains no active ingredient
Eligibility Criteria
You may qualify if:
- 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 .
You may not qualify if:
- 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,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Publications (3)
Tada A, Burkhoff D, Naser JA, Harada T, Pourmussa B, Reddy YNV, Jensen MD, Carter RE, Demmer RT, Testani JM, Chirinos JA, Borlaug BA. Dapagliflozin Enhances Arterial and Venous Compliance During Exercise in Heart Failure With Preserved Ejection Fraction: Insights From the CAMEO-DAPA Trial. Circulation. 2024 Sep 24;150(13):997-1009. doi: 10.1161/CIRCULATIONAHA.124.068788. Epub 2024 Aug 5.
PMID: 39101201DERIVEDReddy YNV, Carter RE, Sorimachi H, Omar M, Popovic D, Alogna A, Jensen MD, Borlaug BA. Dapagliflozin and Right Ventricular-Pulmonary Vascular Interaction in Heart Failure With Preserved Ejection Fraction: A Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2024 Sep 1;9(9):843-851. doi: 10.1001/jamacardio.2024.1914.
PMID: 39046727DERIVEDBorlaug BA, Reddy YNV, Braun A, Sorimachi H, Omar M, Popovic D, Alogna A, Jensen MD, Carter R. Cardiac and Metabolic Effects of Dapagliflozin in Heart Failure With Preserved Ejection Fraction: The CAMEO-DAPA Trial. Circulation. 2023 Sep 5;148(10):834-844. doi: 10.1161/CIRCULATIONAHA.123.065134. Epub 2023 Aug 3.
PMID: 37534453DERIVED
Related Links
MeSH Terms
Interventions
Results Point of Contact
- Title
- Dr. Barry A. Borlaug
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Barry A Borlaug
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 27, 2021
First Posted
January 29, 2021
Study Start
February 24, 2021
Primary Completion
November 17, 2022
Study Completion
November 17, 2022
Last Updated
October 12, 2023
Results First Posted
October 12, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share