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Detecting and Treating Subclinical Anthracycline Therapy Related Cardiac Dysfunction in Low Income Country.

Detecting and Treating Subclinical Anthracycline Therapy Related Cardiac Dysfunction in Low Income Country

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03542058
Acronym
SATRACD
Enrollment
50
Registered
2018-05-31
Start date
2018-06-30
Completion date
2021-06-30
Last updated
2018-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy Related Cardiac Dysfunction

Brief summary

The objective of this research is to describe the burden of subclinical anthracycline therapy related cardiac dysfunction( ATRCD) by applying international guideline on Uganda cancer patient and to evaluate the significance of treating subclinical ATRCD with carvedilol.

Detailed description

Specific objectives: 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.

Interventions

DRUGCarvedilol

Participants who are randomized to treatment group will receive carvedilol for a period of 6 month.

Sponsors

University of Cape Town
CollaboratorOTHER
Uganda Cancer Institute
CollaboratorOTHER
Makerere University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

1. Age between and include 18 and 50 years. 2. Newly diagnosed cancer patients who develop subclinical ATRCD during cardiac follow up.

Exclusion criteria

1. Patient who has been taking carvedilol prior to the study 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

Design outcomes

Primary

MeasureTime frameDescription
Cardiac function6 monthsThis will be measured by mean GLS(Global Longitudinal strain) value.

Contacts

Primary ContactWan Zhu Zhang, Master
raniox@hotmail.com+256774431009
Backup ContactEmmy Okello, PhD
emmyoks@gmail.com+775522284

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026