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NCT03760588: PRADAII
Prevention of Cardiac Dysfunction During Breast Cancer Therapy
Phase 2 trial testing Sacubitril/valsartan in Breast Cancer Female in 138 participants. Completed in 5 September 2024.
5 September 2024
Quick facts
| Lead sponsor | Torbjorn Omland |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 138 |
| Start date | 31 January 2019 |
| Primary completion | 5 September 2024 |
| Estimated completion | 5 September 2024 |
| Sites | 4 locations across Norway |
Drugs / interventions tested
- Sacubitril/valsartan
Conditions studied
- Breast Cancer Female — all drugs for Breast Cancer Female →
- Heart Failure — all drugs for Heart Failure →
Sponsor
Torbjorn Omland
Who can join
18 and older, female only, with Breast Cancer Female or Heart Failure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Breast cancer is the most common cancer among women. The modern post-surgery treatment with chemotherapy, immunotherapy, radiation and hormone therapy has improved the overall 5-years survival drastically. However, an unwanted effect of the post-surgery treatment is its potentially deleterious effect on the heart resulting in cardiac dysfunction. Angiotensin antagonists are used as part of the heart failure treatment. In smaller studies angiotensin antagonists have shown to have a cardioprotective effect during breast cancer treatment. Sacubitril/valsartan is a potent drug that in addition to an angiotensin antagonist contains a neprilysin inhibitor. Sacubitril/valsartan has proved to be superior to enalapril in chronic heart failure. In this randomized placebo controlled double blind trial we hypothesize that sacubitril/valsartan used concomitantly during anthracycline containing chemotherapy for breast cancer treatment prevents cardiac dysfunction as measured by cardiac magnetic resonance imaging (CMR). PRADA II is a Norwegian multicenter trial intending to recruit 214 patients and follow them for 18 months with CMR, cardiac ultrasound, blood samples, functional capacity tests and health related quality of life questionnaires.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03760588
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Sacubitril/valsartan
Trials testing the same drug.
- NCT06142383 — A Proof of Concept and Dose-finding Study of XXB750 in Patients With Heart Failure · Phase 2 · terminated
- NCT05545059 — Effects and Safety of Sacubitril/Valsartan on Refractory Hypertension · Phase 3 · unknown
- NCT05387967 — Safety and Tolerability of Sacubitril/Valsartan in Heart Failure Patient With Reduced Ejection Fraction · Phase 4 · completed
- NCT05096143 — A Cohort Study to Compare the Hospitalization Between Naive Sacubitril/Valsartan and Naive ACEi/ARBs Heart Failure Patie · completed
- NCT05096039 — Role of Sacubitril/Valsartan in Improving Provider Performance in Managing Heart Failure Under Medicare Alternative Paym · completed
Other recruiting trials for Breast Cancer Female
Currently open trials in the same condition.
- NCT07505797 — ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE) · recruiting
- NCT07198724 — ERADICATE: A Phase Ib/II Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4/6 Inhibitor and Endocrin · Phase 1, PHASE2 · recruiting
- NCT07331506 — Validation of the Oncoliq Test for the Early Detection of Breast Cancer. · recruiting
- NCT07214883 — UCF MammoChat: Image Repository · recruiting
- NCT07120100 — Transcranial Magnetic Stimulation for Chemotherapy-Induced Peripheral Neuropathy in Breast and Gynecologic Cancer Surviv · NA · 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 NCT03760588 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Torbjorn Omland
- Last refreshed: 12 February 2025
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/NCT03760588.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing