Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT03542058 |
| Other study ID # |
Cardio-oncology study |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
June 2018 |
| Est. completion date |
June 2021 |
Study information
| Verified date |
May 2018 |
| Source |
Makerere University |
| Contact |
Wan Zhu Zhang, Master |
| Phone |
+256774431009 |
| Email |
raniox[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
