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The Effect of Inflammation in Heart Failure

NCT05330013 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-06-27

No results posted yet for this study

Summary

Background:

Heart failure is a serious health condition. Researchers believe inflammation plays a role. They want to see if adding an additional heart drug to a person s treatment can help treat heart failure with preserved ejection fraction (HFpEF).

Objective:

To learn if chronic inflammation is high in heart failure and if taking dapagliflozin along with the standard of care medicines for 6 months will reduce inflammation and improve heart function in people with HFpEF.

Eligibility:

People aged 18 and older who have heart failure and qualify for dapagliflozin therapy. Healthy adult volunteers are also needed.

Design:

* Participants will be screened with:

* Medical history
* Physical exam
* Heart function tests
* X-ray scans of the heart and blood vessels. They may receive medicines to slow their heart rate or make their heart blood vessels bigger. An intravenous (IV) catheter will be placed in their arm to inject contrast.
* Blood and urine tests
* Participants will have up to 3 study visits. Some screening tests will be repeated.

Participants will take one tablet of the study drug daily for 6 months.

-Participants will have an imaging scan of their heart and blood vessels. They will receive a contrast and stress medicine through an IV to view blood supply.

Participants will have a stress test that measures exercise ability. They will wear sticky pads on their chest, a blood pressure cuff, and a mask. They will also have a 6-Minute Walk Test.

Participants will complete questionnaires about their symptoms and their health.

Participants may be on the study for up to 6 months. They will have a follow-up phone call 1 month after treatment ends.

...

Conditions

Interventions

DRUG

Dapagliflozin

Subjects will be instructed to take dapagliflozin 10 mg once daily for 6 months (with or without food).

DEVICE

MRI scan

For subjects, depending on the subject's heart rate, base, mild, or apex short-axis slices will be acquired during the first pass of the contract (60 measurements).

DEVICE

CMR imaging

Enrolled subjects will undergo stress vasodilator and rest perfusion CMR

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Principal Investigators

  • Wunan Y Zhou, M.D. · National Heart, Lung, and Blood Institute (NHLBI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-23
Primary Completion
2022-06-23
Completion
2022-06-23

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05330013 on ClinicalTrials.gov