Clinical trial · Interventional
Prevention of Cardiac Dysfunction During Adjuvant Breast Cancer Therapy
Prevention of Cardiac Dysfunction During Adjuvant Breast Cancer Therapy: A Randomized, Placebo-controlled, 2x2 Factorial, Double Blind Trial of Candesartan and Metoprolol
NCT01434134CI-TRIAL-00015882PRADAcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Women treated for breast cancer are at increased risk for cardiovascular disease, including heart failure. In this study, by using magnetic resonance imaging (MRI), the investigators want to assess if heart failure medications such as beta blockers and angiotensin receptor blockers can prevent cardiac dysfunction during early breast cancer therapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Heart Failure | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Candesartan | Drug | — | UNRESOLVED |
| Metoprolol | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Metoprolol
- description
- Tablet, target dose 100 mg once daily
- interventionNames
- Drug: Metoprolol
- type
- PLACEBO_COMPARATOR
- label
- Placebo for Metoprolol
- description
- Tablet, target dose 100 mg once daily
- interventionNames
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Candesartan
- description
- Tablet, target dose 32 mg once daily
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged 18-70 years * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Serum creatinine \< 140 μmol/L or estimated creatinine clearance \> 60 ml/min (using the modification of diet and renal disease (MDRD) formula) * Systolic blood pressure \>= 110 mgHg and \< 170 mmHg * LVEF \>= 50% Exclusion Criteria: * Hypotension, defined as systolic blood pressure \< 110 mmHg * Bradycardia, defined as heart rate \< 50 b.p.m. * Prior anthracycline chemotherapy regimen * Prior malignancy requiring chemotherapy or radiotherapy * Symptomatic heart failure * Systolic dysfunction (LVEF \< 50%) * Clinically significant coronary artery disease, valvular heart disease, significant arrhythmias, or conduction delays. * Uncontrolled arterial hypertension defined as systolic blood pressure \> 170 mm Hg * Treatment with ACEI, ARB or beta-blocker within the last 4 weeks prior to study start * Intolerance to ACEI, ARB or beta-blocker * Uncontrolled concomitant serious illness * Pregnancy or breastfeeding * Active abuse of drugs or alcohol * Suspected poor compliance * Inability to tolerate the MRI scanning protocol
References
Publications (4)
- DERIVEDMecinaj A, Gulati G, Ree AH, Gravdehaug B, Rosjo H, Steine K, Wisloff T, Geisler J, Omland T, Heck SL. Impact of the ESC Cardio-Oncology Guidelines Biomarker Criteria on Incidence of Cancer Therapy-Related Cardiac Dysfunction. JACC CardioOncol. 2024 Jan 16;6(1):83-95. doi: 10.1016/j.jaccao.2023.10.008. eCollection 2024 Feb. PMID 38510299
- DERIVEDHeck SL, Mecinaj A, Ree AH, Hoffmann P, Schulz-Menger J, Fagerland MW, Gravdehaug B, Rosjo H, Steine K, Geisler J, Gulati G, Omland T. Prevention of Cardiac Dysfunction During Adjuvant Breast Cancer Therapy (PRADA): Extended Follow-Up of a 2x2 Factorial, Randomized, Placebo-Controlled, Double-Blind Clinical Trial of Candesartan and Metoprolol. Circulation. 2021 Jun 22;143(25):2431-2440. doi: 10.1161/CIRCULATIONAHA.121.054698. Epub 2021 May 16. PMID 33993702
- DERIVEDGulati G, Heck SL, Rosjo H, Ree AH, Hoffmann P, Hagve TA, Norseth J, Gravdehaug B, Steine K, Geisler J, Omland T. Neurohormonal Blockade and Circulating Cardiovascular Biomarkers During Anthracycline Therapy in Breast Cancer Patients: Results From the PRADA (Prevention of Cardiac Dysfunction During Adjuvant Breast Cancer Therapy) Study. J Am Heart Assoc. 2017 Nov 8;6(11):e006513. doi: 10.1161/JAHA.117.006513. PMID 29118031
- DERIVEDHeck SL, Gulati G, Ree AH, Schulz-Menger J, Gravdehaug B, Rosjo H, Steine K, Bratland A, Hoffmann P, Geisler J, Omland T. Rationale and design of the prevention of cardiac dysfunction during an Adjuvant Breast Cancer Therapy (PRADA) Trial. Cardiology. 2012;123(4):240-7. doi: 10.1159/000343622. Epub 2012 Nov 30. PMID 23207160