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

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

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.

Study Overview

• Status: Unknown
• Conditions: Chemotherapy Related Cardiac Dysfunction
• Intervention / Treatment: Drug: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Wan Zhu Zhang, Master; Phone Number: +256774431009; Email: raniox@hotmail.com
• Study Contact Backup: Name: Emmy Okello, PhD; Phone Number: +775522284; Email: emmyoks@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: Carvedilol; Participants who are randomized to treatment group will receive carvedilol for a period of 6 month.; Other Names: Carvedilol Denk
NO_INTERVENTION: Control Group; Study participant will not receive any cardiac medication, apart from standard cancer care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac function	This will be measured by mean GLS(Global Longitudinal strain) value.	6 months

Collaborators and Investigators

• Sponsor: Makerere University
• Collaborators: University of Cape Town; Uganda Cancer Institute
• Investigators: Study Chair: Karen Sliwa, PhD, Hatter Institute for Cardiovascular Disease in Africa; Study Director: Feriel Azibani, PhD, Hatter Institute for Cardiovascular Disease in Africa

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2018
• Primary Completion (ANTICIPATED): June 1, 2021
• Study Completion (ANTICIPATED): June 1, 2021

Study Registration Dates

• First Submitted: May 18, 2018
• First Submitted That Met QC Criteria: May 18, 2018
• First Posted (ACTUAL): May 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 31, 2018
• Last Update Submitted That Met QC Criteria: May 18, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Protective Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Antioxidants; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Carvedilol
• Other Study ID Numbers: Cardio-oncology study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No