Heart FailureNCT02543294

REcovery of Left Ventricular Dysfunction in CAncer Patients (RECAP Trial)

A study testing Echocardiograms, Electrocardiogram and Symptom Questionnaire in people with Heart Failure and Cancer Treatment Induced Left Ventricular Dysfunction, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this clinical trial is to learn if heart function remains normal after stopping heart failure medication in patients who have received chemotherapy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Heart Failure, Cancer Treatment Induced Left Ventricular Dysfunction
What is being tested?: Echocardiograms, Electrocardiogram and Symptom Questionnaire
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 10 Sep 2012to 10 Sep 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

Cancer survivors with no evidence of disease for at least 6 months as determined by the oncologist and no longer receiving cancer treatment.
Prior diagnosis of CILVD with recovered LVEF (i.e. improved to > 50%) for at least 6 months with recommended HF medications (ACE-I or ARB and/or B-blocker).
Absence of other causes of cardiomyopathy (e.g. ischemia, hypertension, amyloidosis, or hemochromatosis) per chart review of the clinician's documentation
Documented normal LVEF for at least 6 months after the initiation of recommended HF therapy.
Age 18 - 80 years. HF clinical guidelines is supported by evidenced-based data from clinical trials which includes individuals up to 80 years of age.
Residence within the United States.
Ability to read and write English, because the MD Anderson Symptom Inventory -Heart Failure (MDASI-HF) instrument (Fadol et al., 2008) has been validated in English only.

Who cannot join

Participants will be excluded if they have a recurrence that requires anti-cancer treatment.
Have a documented history of hypertension, coronary artery disease, myocardial infarction, diabetes mellitus, amyloidosis or hemochromatosis.
Exhibiting HF symptoms (e.g. shortness of breath, edema).
Pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Texas MD Anderson Cancer Center
Houston, Texas, 77030

Other trials in United States

About this study

The goal of this clinical trial is to learn if heart function remains normal after stopping heart failure medication in patients who have received chemotherapy.

Read the detailed description

If you agree to take part in this study, the following baseline tests and procedures will be performed on Day 1:

Your complete medical history will be recorded.
You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, and breathing rate).
You will complete a questionnaire about any symptoms you may be having. The questionnaire should take about 5-10 minutes to complete.
You will have an echocardiogram (ECHO) and an electrocardiogram (ECG) to check your heart function.
You will have blood (about 3 tablespoons) drawn for routine tests. If you can become pregnant, part of this blood draw will be used for a pregnancy test. To take part in this study, you must not be pregnant.
You will be given instructions on how to gradually wean yourself off of your heart failure medication.
You will be given a machine that you will use to measure your blood pressure at home.

You will be asked to monitor your blood pressure and heart rate at home daily and keep the results in a diary. You should bring your diary to each study visit.

At Month 1:

You will have a physical exam, including measurement of your vital signs.
You will complete the questionnaire about any symptoms you may be having.
You will have blood (about 2 teaspoons) drawn for routine tests.

At Months 2, 4, 6, 12, 18, and 30:

You will have a physical exam, including measurement of your vital signs.
You will complete the questionnaire about any symptoms you may be having.
You will have an ECHO.
You will have blood (about 2 teaspoons) drawn for routine tests.

At Months 3 and 5, you will have a telephone follow-up with a member of the research team.

Length of Study Participation:

You may continue taking part in the study for up to 6 continuous months with follow-up visits at Months 12, 18, and 30. You will no longer be able to take part if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

This is an investigational study.

Up to 45 participants will be enrolled in this study. All will take part at MD Anderson.

Conditions: Heart Failure, Cancer Treatment Induced Left Ventricular Dysfunction
Being tested: Echocardiograms, Electrocardiogram, Symptom Questionnaire, Telephone Follow-Up
Keywords: Heart Failure, Echocardiogram, ECHO, Electrocardiogram, ECG, Questionnaire, Survey, Telephone Follow-Up, HF, Cancer treatment induced left ventricular dysfunction, CILVD, Left ventricular ejection fraction, LVEF
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EchocardiogramsDevice
Also called ECHO
Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30.
ElectrocardiogramDevice
Also called ECG
Electrocardiogram performed at baseline.
Symptom QuestionnaireBehavioural
Also called Survey
Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30.
Telephone Follow-UpBehavioural
Telephone follow-up by study staff at months 3 and 5.

Study groups in NCT02543294
Study group	Role	What they receive
Anthracycline Treatment Group	Experimental	Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30. Electrocardiogram performed at baseline. Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30. Telephone follow-up by study staff at months 3 and 5. Receives: Device: Echocardiograms; Device: Electrocardiogram; Behavioral: Symptom Questionnaire; Behavioral: Telephone Follow-Up
Herceptin Treatment Group	Experimental	Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30. Electrocardiogram performed at baseline. Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30. Telephone follow-up by study staff at months 3 and 5. Receives: Device: Echocardiograms; Device: Electrocardiogram; Behavioral: Symptom Questionnaire; Behavioral: Telephone Follow-Up
Combination of Treatments Group	Experimental	Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30. Electrocardiogram performed at baseline. Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30. Telephone follow-up by study staff at months 3 and 5. Receives: Device: Echocardiograms; Device: Electrocardiogram; Behavioral: Symptom Questionnaire; Behavioral: Telephone Follow-Up

What is being measured

The primary outcome is the main question the study is designed to answer.

Determine the Percentage of Cancer Survivors That Maintain Left Ventricular Ejection Fraction (LVEF) ≥50% After Discontinuing Cardiac Medications: Beta Blockers, Angiotensin Converting Enzyme Inhibitors (ACE-I), or Angiotensin Receptor Blockers (ARB).
A withdrawal failure is defined as a decrease in the LVEF when cardiac medications are discontinued as determined by echocardiogram to LVEF<50% or a decrease by 10% from baseline measurement. Maintenance of LVEF is defined as LVEF≥50%. LVEF was assessed at Baseline, Months 2, 4, 6, 12, 18, \& 30.
Measured: A total of 30 months from enrollment date of each participant;

Secondary outcomes (1)

Risk Factors to Predict Early Decline of Myocardial Function During the Weaning of HF (Heart Failure) Medications.
To identify an increased troponin-I that can predict the possibility of HF medication withdrawal failure.
Measured: A total of 30 months from enrollment date of each participant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Sep 201210 Sep 2017

First posted7 Sep 2015 (estimated)
Study start10 Sep 2012
Primary completion10 Sep 2017
Study completion10 Sep 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Heart FailureStudies of the same condition, open and under way.
More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02543294
Sponsor's protocol ID: 2012-0379
Status last verified: Jan 2020
First submitted: 4 Sep 2015
Last updated: 5 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: REcovery of Left Ventricular Dysfunction in CAncer Patients (RECAP Trial)
ClinicalTrials.gov ID: NCT02543294
Acronym / sponsor ID: 2012-0379
Conditions: Heart Failure, Cancer Treatment Induced Left Ventricular Dysfunction
Keywords: Heart Failure, Echocardiogram, ECHO, Electrocardiogram, ECG, Questionnaire, Survey, Telephone Follow-Up
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: M.D. Anderson Cancer CenterUniversity, hospital or other
Study start: 10 Sep 2012 (actual)
Primary completion: 10 Sep 2017 (actual)
Study completion: 10 Sep 2017 (actual)
First posted: 7 Sep 2015 (estimated)
Results: Posted 5 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The goal of this clinical trial is to learn if heart function remains normal after stopping heart failure medication in patients who have received chemotherapy.

Detailed description

If you agree to take part in this study, the following baseline tests and procedures will be performed on Day 1:

Your complete medical history will be recorded.
You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, and breathing rate).
You will complete a questionnaire about any symptoms you may be having. The questionnaire should take about 5-10 minutes to complete.
You will have an echocardiogram (ECHO) and an electrocardiogram (ECG) to check your heart function.
You will have blood (about 3 tablespoons) drawn for routine tests. If you can become pregnant, part of this blood draw will be used for a pregnancy test. To take part in this study, you must not be pregnant.
You will be given instructions on how to gradually wean yourself off of your heart failure medication.
You will be given a machine that you will use to measure your blood pressure at home.

You will be asked to monitor your blood pressure and heart rate at home daily and keep the results in a diary. You should bring your diary to each study visit.

At Month 1:

You will have a physical exam, including measurement of your vital signs.
You will complete the questionnaire about any symptoms you may be having.
You will have blood (about 2 teaspoons) drawn for routine tests.

At Months 2, 4, 6, 12, 18, and 30:

You will have a physical exam, including measurement of your vital signs.
You will complete the questionnaire about any symptoms you may be having.
You will have an ECHO.
You will have blood (about 2 teaspoons) drawn for routine tests.

At Months 3 and 5, you will have a telephone follow-up with a member of the research team.

Length of Study Participation:

This is an investigational study.

Up to 45 participants will be enrolled in this study. All will take part at MD Anderson.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Anthracycline Treatment Group	Experimental	Device: Echocardiograms, Device: Electrocardiogram, Behavioral: Symptom Questionnaire, Behavioral: Telephone Follow-UpParticipants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30. Electrocardiogram performed at baseline. Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30. Telephone follow-up by study staff at months 3 and 5.
Herceptin Treatment Group	Experimental	Device: Echocardiograms, Device: Electrocardiogram, Behavioral: Symptom Questionnaire, Behavioral: Telephone Follow-UpParticipants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30. Electrocardiogram performed at baseline. Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30. Telephone follow-up by study staff at months 3 and 5.
Combination of Treatments Group	Experimental	Device: Echocardiograms, Device: Electrocardiogram, Behavioral: Symptom Questionnaire, Behavioral: Telephone Follow-UpParticipants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30. Electrocardiogram performed at baseline. Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30. Telephone follow-up by study staff at months 3 and 5.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Cancer survivors with no evidence of disease for at least 6 months as determined by the oncologist and no longer receiving cancer treatment.
Prior diagnosis of CILVD with recovered LVEF (i.e. improved to > 50%) for at least 6 months with recommended HF medications (ACE-I or ARB and/or B-blocker).
Absence of other causes of cardiomyopathy (e.g. ischemia, hypertension, amyloidosis, or hemochromatosis) per chart review of the clinician's documentation
Documented normal LVEF for at least 6 months after the initiation of recommended HF therapy.
Age 18 - 80 years. HF clinical guidelines is supported by evidenced-based data from clinical trials which includes individuals up to 80 years of age.

Key exclusion criteria (4 listed)

Participants will be excluded if they have a recurrence that requires anti-cancer treatment.
Have a documented history of hypertension, coronary artery disease, myocardial infarction, diabetes mellitus, amyloidosis or hemochromatosis.
Exhibiting HF symptoms (e.g. shortness of breath, edema).
Pregnancy

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
EchocardiogramsAlso: ECHOParticipants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30.	Device	Anthracycline Treatment Group, Combination of Treatments Group, Herceptin Treatment Group
ElectrocardiogramAlso: ECGElectrocardiogram performed at baseline.	Device	Anthracycline Treatment Group, Combination of Treatments Group, Herceptin Treatment Group
Symptom QuestionnaireAlso: SurveySymptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30.	Behavioural	Anthracycline Treatment Group, Combination of Treatments Group, Herceptin Treatment Group
Telephone Follow-UpTelephone follow-up by study staff at months 3 and 5.	Behavioural	Anthracycline Treatment Group, Combination of Treatments Group, Herceptin Treatment Group

Primary outcome

Determine the Percentage of Cancer Survivors That Maintain Left Ventricular Ejection Fraction (LVEF) ≥50% After Discontinuing Cardiac Medications: Beta Blockers, Angiotensin Converting Enzyme Inhibitors (ACE-I), or Angiotensin Receptor Blockers (ARB).
Time frame: A total of 30 months from enrollment date of each participant;
A withdrawal failure is defined as a decrease in the LVEF when cardiac medications are discontinued as determined by echocardiogram to LVEF<50% or a decrease by 10% from baseline measurement. Maintenance of LVEF is defined as LVEF≥50%. LVEF was assessed at Baseline, Months 2, 4, 6, 12, 18, \& 30.

1 secondary outcome

Risk Factors to Predict Early Decline of Myocardial Function During the Weaning of HF (Heart Failure) Medications.
Time frame: A total of 30 months from enrollment date of each participant

Results and safety

Results posted to the registry on 5 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention (Weaning)	20	8

Primary outcome: Determine the Percentage of Cancer Survivors That Maintain Left Ventricular Ejection Fraction (LVEF) ≥50% After Discontinuing Cardiac Medications: Beta Blockers, Angiotensin Converting Enzyme Inhibitors (ACE-I), or Angiotensin Receptor Blockers (ARB).

Time frame: A total of 30 months from enrollment date of each participant;. Count of participants. Unit: Participants

Measure	Intervention (Weaning) n = 20
Maintained (LVEF </= 50%)	8
Withdrawal Failure (LVEF <50% or decrease of 10%)	2
Lost to Follow Up	3
Withdrawal by Subject	7

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Thirty (30) months from date of enrollment. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention (Weaning)	0 of 20 (0%)	2 of 20 (10%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.

Related trials for Heart Failure

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

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.

Anecita Fadol, PHD, MSN principal investigator

M.D. Anderson Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 4 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: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 5 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Determine the Percentage of Cancer Survivors That Maintain Left Ventricular Ejection Fraction (LVEF) ≥50% After Discontinuing Cardiac Medications: Beta Blockers, Angiotensin Converting Enzyme Inhibitors (ACE-I), or Angiotensin Receptor Blockers (ARB). (time frame: A total of 30 months from enrollment date of each participant;). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02543294.

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 5 Feb 2020.