Detecting and Treating Subclinical Anthracycline Therapy Related Cardiac Dysfunction in Low Income Country.
NCT ID: NCT03542058
Last Updated: 2018-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
50 participants
INTERVENTIONAL
2018-06-30
2021-06-30
Brief Summary
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Detailed Description
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1. To determine the incidence of subclinical ATRCD among cancer patient who receives Anthracycline therapy.
2. To compare the changes of GLS value between hypertension and non hypertension cancer patient at the competition of the anthracycline therapy.
3. To determine the correlation of conventional echocardiograghy(ECHO) parameters (MAPSE, S') with GLS, and their ability to diagnose or rule out subclinical ATRCD.
4. To determine the correlation of oxidative stress with cardiac function(GLS value) in patients who receives Anthracycline therapy
5. To describe the cardioprotective effect of carvedilol in patients with subclinical ATRCD.
METHODS This is going to be two prospective cohort study (cohort 1 and 2) followed by a randomized controlled trial (cohort 3).
To achieve objective 1 ,3 and 4, Cohort 1 will consecutively recruit 300 adult non hypertension cancer patients who are going to receive anthracycline therapy.
To achieve objective 2, Cohort 2 will consecutively recruit 53 adult hypertension cancer patients (group H) and 106 non hypertension controls (group N) who are going to receive anthracycline therapy. Controls will be recruited from cohort 1 by systemic sampling( Choosing the 2nd patients as they are enrolled in cohort 1).
Patient's demographic data, cancer diagnosis, dosage of anthracyclin, past medical history, symptoms, physical examinations, ECG, ECHO and laboratory data will be collected at the baseline. Patient follow up will be performed at the completion of the chemo therapy, and 6month thereafter. Data of symptoms, physical examinations, ECG, ECHO and blood test will be collected at each visit. The end point will be the development of subclinical ATRCD.
To achieve objective 5, patients in Cohort 1, who are diagnosed with Subclinical ATRCD will be recruited into cohort 3 and being randomized into group T(carvedilol treatment group) and group C( control, none treatment group).Systemic randomization will be used in Cohort 3: ever second eligible patient will be recruited in group C. Patients in cohort 3 will be followed up for 6month.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment Group
Study participants will receive carvedilol for a period of 6 month. The initial dosage of carvedilol will be 3.125mg twice daily. Dosage will be titrated up two weekly until the maximum tolerable dose or ceiling dose of 25mg twice daily has been reached.
Carvedilol
Participants who are randomized to treatment group will receive carvedilol for a period of 6 month.
Control Group
Study participant will not receive any cardiac medication, apart from standard cancer care.
No interventions assigned to this group
Interventions
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Carvedilol
Participants who are randomized to treatment group will receive carvedilol for a period of 6 month.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Newly diagnosed cancer patients who develop subclinical ATRCD during cardiac follow up.
Exclusion Criteria
2. Patient who self report to be allergic to carvedilol
3. Systolic blood pressure \< 90mmHg
4. Heart Rate \< 50 beat per minute
5. Patient who is asthmatic or has chronic obstructive lung disease
6. Pregnant woman
18 Years
50 Years
ALL
No
Sponsors
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University of Cape Town
OTHER
Uganda Cancer Institute
OTHER
Makerere University
OTHER
Responsible Party
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Principal Investigators
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Karen Sliwa, PhD
Role: STUDY_CHAIR
Hatter Institute for Cardiovascular Disease in Africa
Feriel Azibani, PhD
Role: STUDY_DIRECTOR
Hatter Institute for Cardiovascular Disease in Africa
Central Contacts
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Other Identifiers
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Cardio-oncology study
Identifier Type: -
Identifier Source: org_study_id