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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin Group | Experimental | Subjects with HFpEF will take the study drug dapagliflozin daily |
|
| Placebo Group | Placebo Comparator | Subjects with HFpEF will take a placebo daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | 10 mg orally once a day |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | Change in body weight as measured in kilograms (kg) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barry A Borlaug | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39101201 | Derived | 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. | |
| 39046727 |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dapagliflozin Group | Subjects with heart failure/preserved ejection fraction (HFpEF) will take the study drug dapagliflozin daily Dapagliflozin: 10 mg orally once a day |
| FG001 | Placebo Group | Subjects with HFpEF will take a placebo daily Placebo: Taken orally once a day, the placebo looks identical to the study drug but it contains no active ingredient |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dapagliflozin Group | Subjects with HFpEF will take the study drug dapagliflozin daily Dapagliflozin: 10 mg orally once a day |
| BG001 | Placebo Group | Subjects with HFpEF will take a placebo daily Placebo: Taken orally once a day, the placebo looks identical to the study drug but it contains no active ingredient |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | mmHg | Baseline, 24 weeks |
|
Adverse events were collected on each participant from enrollment through approximately one week following the final on-site study visit for a total of approximately seven months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dapagliflozin Group | Subjects with HFpEF will take the study drug dapagliflozin daily Dapagliflozin: 10 mg orally once a day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| humerus fracture | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Minor bruising or bleeding following catheterization | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Barry A. Borlaug | Mayo Clinic | 507-293-2762 | borlaug.barry@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 13, 2022 | Sep 20, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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| Drug |
Taken orally once a day, the placebo looks identical to the study drug but it contains no active ingredient |
|
| 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) | 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. | 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. | 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. | 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. | Baseline, 24 weeks |
| Derived |
| Reddy 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. |
| 37534453 | Derived | Borlaug 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | mmHg | Baseline, 24 weeks |
|
|
|
|
| Secondary | Change in Body Weight | Change in body weight as measured in kilograms (kg) | Posted | Mean | Standard Deviation | kg | Baseline, 24 weeks |
|
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | mL | Baseline, 24 weeks |
|
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | mL | Baseline, 24 weeks |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mmHg | Baseline, 24 weeks |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mmHg | Baseline, 24 weeks |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mmHg | Baseline, 24 weeks |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mmHg | Baseline, 24 weeks |
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|
| 0 |
| 21 |
| 4 |
| 21 |
| 21 |
| 21 |
| EG001 | Placebo Group | Subjects with HFpEF will take a placebo daily Placebo: Taken orally once a day, the placebo looks identical to the study drug but it contains no active ingredient | 0 | 17 | 0 | 17 | 17 | 17 |
| pneumonia related to COVID-19 | Infections and infestations | Systematic Assessment |
|
| allergic food reaction | General disorders | Systematic Assessment |
|
| hospitalization | General disorders | Systematic Assessment | Hospitalization due to patient not having someone to accompany them to hotel following catheterization |
|
| Dizziness or dehydration | General disorders | Systematic Assessment |
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| Genitourinary infections | Infections and infestations | Systematic Assessment |
|
| Hypoglycemia | General disorders | Systematic Assessment |
|
| Worsening dyspenea | General disorders | Systematic Assessment |
|
| Worsening fatigue | General disorders | Systematic Assessment |
|
| Medication intolerance | General disorders | Systematic Assessment |
|
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