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Completed

NCT Number: NCT04730947

Dapagliflozin (DAPA) Effects in HFpEF

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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Key information

Conditions

Heart Failure With Preserved Ejection Fraction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Dapagliflozin

Drug

10 mg orally once a day

Placebo

Drug

Taken orally once a day, the placebo looks identical to the study drug but it contains no active ingredient

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Change in Body Weight

    Time frame: Baseline, 24 weeks

    Change in body weight as measured in kilograms (kg)

  2. Change in Total Blood Volume

    Time frame: Baseline, 24 weeks

    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)

  3. Change in Plasma Volume

    Time frame: Baseline, 24 weeks

    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)

  4. Change in Right Atrial (RA) Pressure at Maximal Exercise

    Time frame: Baseline, 24 weeks

    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.

  5. Change in Right Atrial (RA) Pressure at Rest

    Time frame: Baseline, 24 weeks

    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.

  6. Change in Mean Pulmonary Arterial Pressure (PA) at Maximal Exercise

    Time frame: Baseline, 24 weeks

    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.

  7. Change in Mean Pulmonary Arterial Pressure (PA) at Rest

    Time frame: Baseline, 24 weeks

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 29, 2021
Registry last updated
Oct 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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