Dapagliflozin (DAPA) Effects in HFpEF

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-24

Study Completion Date

2022-11-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Dapagliflozin on Submaximal Exercise Tolerance in Heart Failure

NCT04956809

HFrEF

COMPLETED PHASE2

DETERMINE-reduced - Dapagliflozin Effect on Exercise Capacity Using a 6-minute Walk Test in Patients With Heart Failure With Reduced Ejection Fraction

NCT03877237

Heart Failure With Reduced Ejection Fraction (HFrEF)

COMPLETED PHASE3

Stratified Treatment to Ameliorate Diastolic Left Ventricular Stiffness in Heart Failure With Preserved Ejection Fraction

NCT04475042

Heart Failure, Diastolic

UNKNOWN PHASE2

CAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation

NCT06762964

Fontan Circulation Single Ventricle Heart Disease HFpEF - Heart Failure With Preserved Ejection Fraction

RECRUITING PHASE2

Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure.

NCT03619213

Heart Failure With Preserved Ejection Fraction

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure With Preserved Ejection Fraction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dapagliflozin Group

Subjects with HFpEF will take the study drug dapagliflozin daily

Group Type EXPERIMENTAL

Dapagliflozin

Intervention Type DRUG

10 mg orally once a day

Placebo Group

Subjects with HFpEF will take a placebo daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dapagliflozin

10 mg orally once a day

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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,

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No