NCT03542058

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Makerere University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chemotherapy Related Cardiac Dysfunction

Interventions

Type	Name	Description
DRUG	Carvedilol	Participants who are randomized to treatment group will receive carvedilol for a period of 6 month.

Timeline

• Start date: 2018-06-01
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2018-05-31
• Last updated: 2018-05-31