Heart Failure With Preserved Ejection FractionPhase 2NCT04730947
Dapagliflozin (DAPA) Effects in HFpEF
A Phase 2 study testing Dapagliflozin in people with Heart Failure With Preserved Ejection Fraction, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2021to 17 Nov 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 .
Who cannot join
- 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.
Show all 9Show fewer
- 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,
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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
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.
- Being tested
- Dapagliflozin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
10 mg orally once a day
PlaceboDrug
Taken orally once a day, the placebo looks identical to the study drug but it contains no active ingredient
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin Group | Experimental | Subjects with HFpEF will take the study drug dapagliflozin daily Receives: Drug: Dapagliflozin |
| Placebo Group | Placebo comparator | Subjects with HFpEF will take a placebo daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 24 weeks
Secondary outcomes (7)
Change in Body Weight
Change in body weight as measured in kilograms (kg)
Measured: Baseline, 24 weeks
Change in Total Blood Volume
Total blood volume was assessed using a radiolabeled iodinated albumin (131I, 5-25 μCu) indicator dilution technique with the BVA-100 Blood Volume Analyzer. Measured in millimeters (mL)
Measured: Baseline, 24 weeks
Change in Plasma Volume
Plasma volume was assessed using a radiolabeled iodinated albumin (131I, 5-25 μCu) indicator dilution technique with the BVA-100 Blood Volume Analyzer. Measured in millimeters (mL)
Measured: Baseline, 24 weeks
Change in Right Atrial (RA) Pressure at Maximal Exercise
Right Atrial (RA) 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.
Measured: Baseline, 24 weeks
Change in Right Atrial (RA) Pressure at Rest
Right Atrial (RA) 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.
Measured: Baseline, 24 weeks
Change in Mean Pulmonary Arterial Pressure (PA) at Maximal Exercise
Pulmonary Arterial (PA) 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.
Measured: Baseline, 24 weeks
Change in Mean Pulmonary Arterial Pressure (PA) at Rest
Pulmonary Arterial (PA) 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.
Measured: Baseline, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start24 Feb 2021
- Primary completion17 Nov 2022
- Study completion17 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barry Borlaug, Mayo Clinic
- Investigators
- Barry A Borlaug, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730947
- Sponsor's protocol ID
- 20-005646
- Status last verified
- Sep 2023
- First submitted
- 27 Jan 2021
- Last updated
- 12 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39101201Reddy 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.
PubMed 39046727Borlaug 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.
PubMed 37534453
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04730947
- Acronym / sponsor ID
- 20-005646
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 17 Nov 2022 (actual)
- Study completion
- 17 Nov 2022 (actual)
- First posted
- 29 Jan 2021 (actual)
- Results
- Posted 12 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin Group | Experimental | Drug: DapagliflozinSubjects with HFpEF will take the study drug dapagliflozin daily |
| Placebo Group | Placebo comparator | Drug: PlaceboSubjects with HFpEF will take a placebo daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 .
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin10 mg orally once a day | Drug | Dapagliflozin Group |
| PlaceboTaken orally once a day, the placebo looks identical to the study drug but it contains no active ingredient | Drug | Placebo Group |
Primary outcome
Pulmonary Capillary Wedge Pressure (PCWP) at Maximal Exercise
Time frame: Baseline, 24 weeks
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.
Pulmonary Capillary Wedge Pressure (PCWP) at Rest
Time frame: Baseline, 24 weeks
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.
7 secondary outcomes
Change in Body Weight
Time frame: Baseline, 24 weeks
Change in Total Blood Volume
Time frame: Baseline, 24 weeks
Change in Plasma Volume
Time frame: Baseline, 24 weeks
Change in Right Atrial (RA) Pressure at Maximal Exercise
Time frame: Baseline, 24 weeks
Change in Right Atrial (RA) Pressure at Rest
Time frame: Baseline, 24 weeks
Change in Mean Pulmonary Arterial Pressure (PA) at Maximal Exercise
Time frame: Baseline, 24 weeks
Change in Mean Pulmonary Arterial Pressure (PA) at Rest
Time frame: Baseline, 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39101201Tada 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.
- Derived from this study: PubMed 39046727Reddy 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.
- Derived from this study: PubMed 37534453Borlaug 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.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry A Borlaug principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dapagliflozin in people with Heart Failure With Preserved Ejection Fraction, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Capillary Wedge Pressure (PCWP) at Maximal Exercise (time frame: Baseline, 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04730947, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023; AzTrials last refreshed its copy on 30 Oct 2026.