Heart FailureNCT04413487
Early Detection of Heart Problems in Cancer Patients Receiving Chemotherapy
An observational study of Heart Failure, run by The Guthrie Clinic.
Trial summary
Subjects will include patients diagnosed with breast cancer or hematological cancer who are planned for chemotherapy treatment with anthracycline or trastuzumab; and who have one or more risk factors for cardiovascular disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Extra echocardiogram
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2020to 28 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will include patients diagnosed with breast cancer or hematological cancer who are planned for chemotherapy treatment with anthracycline or trastuzumab; and who have one or more risk factors for cardiovascular disease including LVEF 50-54% by baseline echocardiogram; Age ≥ 65; BMI ≥ 30 kg/m2;current or prior anti-hypertensive therapy; diagnosis of coronary artery disease (CAD); Diabetes Mellitus or Atrial fibrillation/flutter.
Who may be able to join
- Males and females 18 years and above
- Willing and able to provide consent
- Able to read
- Patients diagnosed with breast cancer or hematological cancer who are planned for chemotherapy treatment with anthracycline or trastuzumab.
- Patients at increased risk of cardiotoxicity with one or more risk factors for heart disease:
- LVEF 50-54% by baseline echocardiogram
Show all 12Show fewer
- Age ≥ 65
- BMI ≥ 30 kg/m2
- Current or prior anti-hypertensive therapy
- Diagnosis of coronary artery disease (CAD)
- Diabetes Mellitus
- Atrial fibrillation/flutter
Who cannot join
- Children
- Patients who are pregnant
- Only single encounter without follow up
- Cancer diagnosis other than breast or hematological cancer
- Chemotherapy treatment other than anthracycline or trastuzumab
- No prior chemotherapy treatment
About this study
Official title: Strain Echocardiogram in Early Detection of Left Ventricular Dysfunction in Cancer Patients Receiving Chemotherapy
Subjects will include patients diagnosed with breast cancer or hematological cancer who are planned for chemotherapy treatment with anthracycline or trastuzumab; and who have one or more risk factors for cardiovascular disease. Subjects will received an extra echocardiogram to determine if heart problems can be detected earlier.
Read the detailed description
- Patients scheduled for potentially cardiotoxic chemotherapy would receive a baseline echocardiogram as per standard protocol which should be covered by the routine insurance
- Follow-up with an extra echocardiogram for research purposes would be performed after 2 cycles of that chemotherapy - supplied by the study
- Clinical assessment at 3 to 6 months including repeat echocardiography as per standard care with the research question as whether any differences in strain pattern between pre-chemo and post 2 cycles studies all identify patients who are more likely to have cardiac issues later.
- Patients will have standard of care visits at 3 month, 6 month and 12 month and will be evaluated for cardiac status and survival.
- Patient records will be reviewed at 5 years to check cardiac status and survival.
- Conditions
- Heart Failure
- Being tested
- Extra echocardiogram
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra echocardiogramOther
Subjects will receive an extra echocardiogram after 2 cycles of chemotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in left ventricular ejection fraction (LVEF)
a decrease in LVEF of ≥10 percentage points from baseline to a value of < 50% OR a decrease of LVEF by ≥ 5 percentage points from baseline to LVEF <50% for patients who have a baseline LVEF of 50-54%
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
Survival status
alive or deceased
Measured: through study completion, an average of 1 year
Change in symptoms that may be indicative of heart failure
Presence of absence of symptoms
Measured: through study completion, an average of 1 year
Change in treatment that may be indicative of heart failure
Presence or absence of treatment for heart failure
Measured: through study completion, an average of 1 year
Change in strain echo that may be indicative of heart failure
Presence or absence of heart failure by imaging
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study startMar 2020 (estimated)
- Primary completion28 May 2020
- Study completion28 May 2020
Why it stopped: Study never started due to change in standard of care guideline
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Guthrie Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philip Lowry, MD, Principal investigator, The Guthrie Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413487
- Sponsor's protocol ID
- 20
- Status last verified
- May 2020
- First submitted
- 9 Dec 2019
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strain Echocardiogram in Early Detection of Left Ventricular Dysfunction in Cancer Patients Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT04413487
- Acronym / sponsor ID
- 20
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study never started due to change in standard of care guideline
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Guthrie ClinicUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- 28 May 2020 (actual)
- Study completion
- 28 May 2020 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects will include patients diagnosed with breast cancer or hematological cancer who are planned for chemotherapy treatment with anthracycline or trastuzumab; and who have one or more risk factors for cardiovascular disease. Subjects will received an extra echocardiogram to determine if heart problems can be detected earlier.
Detailed description
- Patients scheduled for potentially cardiotoxic chemotherapy would receive a baseline echocardiogram as per standard protocol which should be covered by the routine insurance
- Follow-up with an extra echocardiogram for research purposes would be performed after 2 cycles of that chemotherapy - supplied by the study
- Clinical assessment at 3 to 6 months including repeat echocardiography as per standard care with the research question as whether any differences in strain pattern between pre-chemo and post 2 cycles studies all identify patients who are more likely to have cardiac issues later.
- Patients will have standard of care visits at 3 month, 6 month and 12 month and will be evaluated for cardiac status and survival.
- Patient records will be reviewed at 5 years to check cardiac status and survival.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will include patients diagnosed with breast cancer or hematological cancer who are planned for chemotherapy treatment with anthracycline or trastuzumab; and who have one or more risk factors for cardiovascular disease including LVEF 50-54% by baseline echocardiogram; Age ≥ 65; BMI ≥ 30 kg/m2;current or prior anti-hypertensive therapy; diagnosis of coronary artery disease (CAD); Diabetes Mellitus or Atrial fibrillation/flutter.
Key inclusion criteria (12 listed)
- Males and females 18 years and above
- Willing and able to provide consent
- Able to read
- Patients diagnosed with breast cancer or hematological cancer who are planned for chemotherapy treatment with anthracycline or trastuzumab.
- Patients at increased risk of cardiotoxicity with one or more risk factors for heart disease:
Key exclusion criteria (6 listed)
- Children
- Patients who are pregnant
- Only single encounter without follow up
- Cancer diagnosis other than breast or hematological cancer
- Chemotherapy treatment other than anthracycline or trastuzumab
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extra echocardiogramSubjects will receive an extra echocardiogram after 2 cycles of chemotherapy | Other | – |
Primary outcome
Change in left ventricular ejection fraction (LVEF)
Time frame: through study completion, an average of 1 year
a decrease in LVEF of ≥10 percentage points from baseline to a value of < 50% OR a decrease of LVEF by ≥ 5 percentage points from baseline to LVEF <50% for patients who have a baseline LVEF of 50-54%
4 secondary outcomes
Survival status
Time frame: through study completion, an average of 1 year
Change in symptoms that may be indicative of heart failure
Time frame: through study completion, an average of 1 year
Change in treatment that may be indicative of heart failure
Time frame: through study completion, an average of 1 year
Change in strain echo that may be indicative of heart failure
Time frame: through study completion, an average of 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Lowry, MD principal investigator
The Guthrie Clinic
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by The Guthrie Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in left ventricular ejection fraction (LVEF) (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020; AzTrials last refreshed its copy on 8 Nov 2026.