Prevention of Cardiac Dysfunction During Adjuvant Breast Cancer Therapy (PRADA)
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ClinicalTrials.gov Identifier: NCT01434134 |
Recruitment Status :
Completed
First Posted : September 14, 2011
Last Update Posted : October 22, 2014
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Condition or disease | Intervention/treatment | Phase |
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Breast Cancer Heart Failure | Drug: Metoprolol Drug: Placebo Drug: Candesartan | Phase 2 |
Breast cancer is one of the most common malignancies in women. Recent progress in the detection and treatment of breast cancer has resulted in survival gains, but a consequence of therapeutic advances is an increasing number of long-term survivors who may be at risk for development of cardiovascular disease. Several studies suggest that women treated for breast cancer may be at increased risk for cardiovascular disease, the probable causes being multi-factorial. Importantly, therapies for breast cancer, including radiotherapy, anti-HER-2 regimens and certain chemotherapeutic regimens, may increase the risk of subsequent cardiovascular disease, including atherosclerotic disease, left ventricular dysfunction, and heart failure.
In the current study we propose to undertake a randomized, placebo-controlled, 2x2 factorial, double-blind trial to assess whether left ventricular dysfunction and/or injury is preventable, completely or partly, by the concomitant administration of the angiotensin receptor blocker (ARB), candesartan, and the beta blocker, metoprolol, during postoperative chemotherapy and radiotherapy.
The proposed study addresses an important clinical problem in a large patient group. Thus, the possibility of preventing cardiovascular side effects of contemporary therapy for breast cancer is important both clinically and scientifically.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 130 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Prevention of Cardiac Dysfunction During Adjuvant Breast Cancer Therapy: A Randomized, Placebo-controlled, 2x2 Factorial, Double Blind Trial of Candesartan and Metoprolol |
Study Start Date : | September 2011 |
Actual Primary Completion Date : | September 2014 |
Actual Study Completion Date : | September 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Metoprolol
Tablet, target dose 100 mg once daily
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Drug: Metoprolol
Tablet, target dose 100 mg once daily |
Placebo Comparator: Placebo for Metoprolol
Tablet, target dose 100 mg once daily
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Drug: Placebo
Tablet, target dose 100 mg once daily |
Experimental: Candesartan
Tablet, target dose 32 mg once daily
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Drug: Candesartan
Tablet, target dose 32 mg once daily |
Placebo Comparator: Placebo for Candesartan
Tablet, target dose 32 mg once daily
|
Drug: Placebo
Tablet, 32 mg once daily |
- Change in left ventricular ejection fraction, as assessed by cardiac MRI [ Time Frame: Baseline and end of study (up to 72 weeks) ]
- Change in contrast enhancement by MRI [ Time Frame: Baseline and approximately 4 weeks ]
- Change in left 2D global strain, as assessed by echocardiography [ Time Frame: Baseline and end of study (up to 72 weeks) ]
- Incidence of clinical of heart failure or objective left ventricular dysfunction [ Time Frame: Up to 72 weeks ]Left ventricular dysfunction defined as ejection fraction < 55% by cardiac MRI
- Change in biochemical markers of cardiac injury, i.e. hs-cTnT [ Time Frame: Baseline and end of study (up to 72 weeks) ]
- Change in left ventricular diastolic function, as assessed by echocardiography [ Time Frame: Baseline and end of study (up to 72 weeks) ]Diastolic function assessed by e/e'
- Change in biochemical markers of cardiac function, i.e. NT-proBNP [ Time Frame: Baseline and end of study (up to 72 weeks) ]
- Change in contrast enhancement, as assessed by cardiac MRI [ Time Frame: Baseline and end of study (up to 72 weeks) ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01434134
Norway | |
Akershus University Hospital | |
Lørenskog, Norway, 1478 |
Study Director: | Stein Vaaler | University Hospital, Akershus |
Responsible Party: | Torbjorn Omland, Professor of Medicine, University Hospital, Akershus |
ClinicalTrials.gov Identifier: | NCT01434134 |
Other Study ID Numbers: |
2709001/90005 |
First Posted: | September 14, 2011 Key Record Dates |
Last Update Posted: | October 22, 2014 |
Last Verified: | October 2014 |
Anthracyclines Trastuzumab |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Metoprolol Candesartan Anti-Arrhythmia Agents Antihypertensive Agents Sympatholytics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |