Last reviewed · How we verify
NCT05330013
The Effect of Inflammation in Heart Failure
Phase 2 trial testing Dapagliflozin in Myocardial Dysfunction. Withdrawn.
23 June 2022
Quick facts
| Lead sponsor | National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | basic science |
| Start date | 23 June 2022 |
| Primary completion | 23 June 2022 |
| Estimated completion | 23 June 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Dapagliflozin (DAPAGLIFLOZIN) — full drug profile →
- MRI scan
- CMR imaging
Conditions studied
- Myocardial Dysfunction — all drugs for Myocardial Dysfunction →
- Heart Failure — all drugs for Heart Failure →
- Inflammation — all drugs for Inflammation →
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Who can join
Adults 18 to 90, any sex, with Myocardial Dysfunction or Heart Failure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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. ...
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
NLRP3 inflammasome: a key player in the pathogenesis of life-style disorders.
Ramachandran R, Manan A, Kim J, Choi S. · · 2024 · cited 67× · PMID 38945951 · DOI 10.1038/s12276-024-01261-8
Verify or expand the search:
- PubMed search for NCT05330013
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Myocardial Dysfunction
Currently open trials in the same condition.
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- NCT04765943 — Prognosis Impact of NSVTs After an AMI (TeVeO Study). · active not recruiting
Other National Heart, Lung, and Blood Institute (NHLBI) trials
Trials by the same sponsor.
- NCT07566494 — Escalating Doses of VAS-101 in Subjects With Stable Sickle Cell Disease · Phase 1 · not yet recruiting
- NCT07137455 — EDEN Intracardiac Electrogram Recording and Classifying System · NA · enrolling by invitation
- NCT05372627 — NHLBI-Emory Advanced Cardiac CT Reconstruction · not yet recruiting
- NCT07516379 — GRAfT 2.0. A Multimodal Prospective Approach to Define the Mechanisms and Clinical Features of Acute and Chronic Rejecti · not yet recruiting
- NCT06948097 — Syk Inhibition in MItigating Lung Allograft Rejection (SIMILAR): A Trial to Evaluate the Safety and Tolerability of Fost · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05330013 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI)
- Last refreshed: 27 June 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05330013.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing