Clinical trial NCT03542058: Detecting and Treating Subclinical Anthracycline Therapy Related Cardiac Dysfunction in Low Income Country.
Official title: Detecting and Treating Subclinical Anthracycline Therapy Related Cardiac Dysfunction in Low Income Country
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chemotherapy Related Cardiac Dysfunction
Lead sponsor: Makerere University
Sponsor class: OTHER
Collaborators: name: University of Cape Town
name: Uganda Cancer Institute
First posted: 2018-05-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiac function
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hatter Institute for Cardiovascular Disease in Africa
name: Karen Sliwa, PhD
role: STUDY_CHAIR
affiliation: Hatter Institute for Cardiovascular Disease in Africa
name: Feriel Azibani, PhD
role: STUDY_DIRECTOR
References: