Dapagliflozin (DAPA) Effects in HFpEF

Heart Failure With Preserved Ejection Fraction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04730947
• Other study ID #: 20-005646
• Status: Completed
• Phase: Phase 2
• Start date: February 24, 2021
• Est. completion date: November 17, 2022

Study information

• Verified date: September 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 17, 2022
• Est. primary completion date: November 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction

Intervention

Drug:
• Dapagliflozin
10 mg orally once a day
• Placebo
Taken orally once a day, the placebo looks identical to the study drug but it contains no active ingredient

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline, 24 weeks
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.	Baseline, 24 weeks
Secondary	Change in Body Weight	Change in body weight as measured in kilograms (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)	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)	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.	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.	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.	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.	Baseline, 24 weeks

External Links

•   Mayo Clinic Clinical Trials