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Dapagliflozin (DAPA) Effects in HFpEF

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT04730947
Collaborator
(none)
46
Enrollment
1
Location
2
Arms
28.8
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 24, 2021
Anticipated Primary Completion Date :
Jan 21, 2023
Anticipated Study Completion Date :
Jul 21, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dapagliflozin Group

Subjects with HFpEF will take the study drug dapagliflozin daily

Drug: Dapagliflozin
10 mg orally once a day
Placebo Comparator: Placebo Group

Subjects with HFpEF will take a placebo daily

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

Outcome Measures

Primary Outcome Measures

  1. Pulmonary Capillary Wedge Pressure (PCWP) [Baseline, 7 months]

    Change in the PCWP during exercise reported in mmHg

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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,

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Barry A Borlaug, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Barry Borlaug, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT04730947
Other Study ID Numbers:
  • 20-005646
First Posted:
Jan 29, 2021
Last Update Posted:
Mar 24, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Heart Failure
Dapagliflozin

Study Results

No Results Posted as of Mar 24, 2022