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Dapagliflozin (DAPA) Effects in HFpEF

Primary Purpose

Heart Failure With Preserved Ejection Fraction

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dapagliflozin
Placebo
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure With Preserved Ejection Fraction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 revasculariation (< 90 days).
  • Primary cardiomyopathy (such as amyloid).
  • Constrictive pericarditis.
  • Dyspea due to primary lung disease or myoardial 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 GFR < 30) or liver disease,

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dapagliflozin Group

Placebo Group

Arm Description

Subjects with HFpEF will take the study drug dapagliflozin daily

Subjects with HFpEF will take a placebo daily

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Change in Body Weight
Change in body weight as measured in kilograms (kg)
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)
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)
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.
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.
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.
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.

Full Information

First Posted
January 27, 2021
Last Updated
September 20, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04730947
Brief Title
Dapagliflozin (DAPA) Effects in HFpEF
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 24, 2021 (Actual)
Primary Completion Date
November 17, 2022 (Actual)
Study Completion Date
November 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Preserved Ejection Fraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dapagliflozin Group
Arm Type
Experimental
Arm Description
Subjects with HFpEF will take the study drug dapagliflozin daily
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Subjects with HFpEF will take a placebo daily
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Intervention Description
10 mg orally once a day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Taken orally once a day, the placebo looks identical to the study drug but it contains no active ingredient
Primary Outcome Measure Information:
Title
Pulmonary Capillary Wedge Pressure (PCWP) at Maximal Exercise
Description
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.
Time Frame
Baseline, 24 weeks
Title
Pulmonary Capillary Wedge Pressure (PCWP) at Rest
Description
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.
Time Frame
Baseline, 24 weeks
Secondary Outcome Measure Information:
Title
Change in Body Weight
Description
Change in body weight as measured in kilograms (kg)
Time Frame
Baseline, 24 weeks
Title
Change in Total Blood Volume
Description
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)
Time Frame
Baseline, 24 weeks
Title
Change in Plasma Volume
Description
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)
Time Frame
Baseline, 24 weeks
Title
Change in Right Atrial (RA) Pressure at Maximal Exercise
Description
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.
Time Frame
Baseline, 24 weeks
Title
Change in Right Atrial (RA) Pressure at Rest
Description
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.
Time Frame
Baseline, 24 weeks
Title
Change in Mean Pulmonary Arterial Pressure (PA) at Maximal Exercise
Description
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.
Time Frame
Baseline, 24 weeks
Title
Change in Mean Pulmonary Arterial Pressure (PA) at Rest
Description
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.
Time Frame
Baseline, 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry A Borlaug
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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Dapagliflozin (DAPA) Effects in HFpEF

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