Dapagliflozin (DAPA) Effects in HFpEF

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04730947

Enrollment

Registered

2021-01-29

Start date

2021-02-24

Completion date

2022-11-17

Last updated

2023-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure With Preserved Ejection Fraction

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.

Interventions

DRUGDapagliflozin

10 mg orally once a day

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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 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,

Design outcomes

Primary

Measure	Time frame	Description
Pulmonary Capillary Wedge Pressure (PCWP) at Maximal Exercise	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	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

Measure	Time frame	Description
Change in Plasma Volume	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)
Change in Right Atrial (RA) Pressure at Maximal Exercise	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.
Change in Body Weight	Baseline, 24 weeks	Change in body weight as measured in kilograms (kg)
Change in Mean Pulmonary Arterial Pressure (PA) at Maximal Exercise	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.
Change in Mean Pulmonary Arterial Pressure (PA) at Rest	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.
Change in Right Atrial (RA) Pressure at Rest	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.
Change in Total Blood Volume	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)

Countries

United States

Participant flow

Participants by arm

Arm	Count
Dapagliflozin Group Subjects with HFpEF will take the study drug dapagliflozin daily Dapagliflozin: 10 mg orally once a day	21
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	17
Total	38

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Withdrawal by Subject	0	1

Baseline characteristics

Characteristic	Placebo Group	Total	Dapagliflozin Group
Age, Continuous	67 years STANDARD_DEVIATION 9	67 years STANDARD_DEVIATION 9	67 years STANDARD_DEVIATION 9
Race and Ethnicity Not Collected	—	0 Participants	—
Region of Enrollment United States	17 participants	38 participants	21 participants
Sex: Female, Male Female	11 Participants	25 Participants	14 Participants
Sex: Female, Male Male	6 Participants	13 Participants	7 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 21	0 / 17
other Total, other adverse events	21 / 21	17 / 17
serious Total, serious adverse events	4 / 21	0 / 17

Outcome results

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.