Heart and Blood Diseases

All Conditions

Heart Failure

Ventricular Dysfunction, Left

Ventricular Dysfunction

Heart Diseases

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.

Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30.

Echocardiograms

Electrocardiogram

Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30.

Symptom Questionnaire

Telephone follow-up by study staff at months 3 and 5.

Telephone Follow-Up

Anecita Fadol, PHD, MSN

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.

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.

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

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.

To identify an increased troponin-I that can predict the possibility of HF medication withdrawal failure.

M.D. Anderson Cancer Center

Weaning of Cardiac Medications Based on Therapeutic Category (i.e. Beta Blockers, ACE-I, ARB, or any combination of these medications.)

Intervention (Weaning)

Down titrated current dose by half each week until medication is off. Weaning order: ACE-I, ARB, and beta blocker.

Maintenance of LVEF ≥50% after weaning of heart failure medications.

Age, Categorical

Age, Continuous

< 30

>/= 30-39

>/= 40-49

>/= 50-59

>/= 60

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

LVEF ≥50%, taking heart failure medications classified as Angiotension converting enzyme inhibitors (ACE-Inhibitors), Beta-blockers, and/or angiotension-receptor blockers (ARBs), no diabetes, no hypertension, no arrhythmias, cancer in remission for at least 6 months

Left ventricular ejection fraction (LVEF) ≥50%

Patients at MD Anderson that met inclusion criteria (specified in Recruitment Details) and not excluded due to: Cancer recurrence; documented history of hypertension, coronary artery disease, myocardial infarction, diabetes mellitus, amyloidosis or hemochromatosis; presence of HF symptoms (e.g. shortness of breath, edema); Pregnancy.

Dr. Anecita P. Fadol,PHD/Associate Professor, Department of Nursing

Maintained (LVEF </= 50%)

Withdrawal Failure (LVEF <50% or decrease of 10%)

Lost to Follow Up

Withdrawal by Subject

"Weaning of Cardiac Medications Based on Therapeutic Category (i.e. Beta Blockers, ACE-I, ARB, or any combination of these medications.)"

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).

The standard deviation is 0 because every value collected over the course of the entire study was 0.03. Mean would be 0.03 with a standard deviation of 0

Risk Factors to Predict Early Decline of Myocardial Function During the Weaning of HF (Heart Failure) Medications.

Overall Study

Neoplasms

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Substance Related Disorders

Wounds and Injuries

Breast Neoplasms

Cardiotoxicity

Breast Diseases

Skin Diseases

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

Hypoglycemic Agents

All Drugs and Chemicals

Antineoplastic Agents

Anti-Infective Agents

Metformin

Doxorubicin

Liposomal doxorubicin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Patients will receive standard of care for their breast cancer with no metformin during their treatment with doxorubicin.

Patients will receive metformin during their treatment with doxorubicin for their breast cancer.

Metformin will begin to be administered prior to treatment with doxorubicin. Metformin will continue to be given throughout doxorubicin cycles until the completion of doxorubicin therapy.

Standard of care treatment with doxorubicin

Kirstin Williams, CNP

The goal of this study is to determine if co-administration of metformin and doxorubicin in breast cancer patients receiving neoadjuvant or adjuvant therapy will reduce the number of patients who develop a significant change in left ventricle ejection fraction (LVEF).

This is a randomized, open-label, phase II design pilot study in patients with breast cancer requiring neoadjuvant or adjuvant chemotherapy. Eligible patients will be equally randomized to either receive metformin plus standard of care therapy or standard of care therapy alone. Patients receiving metformin will continue drug until the doxorubicin-containing cycles are complete, unless unacceptable toxicity occurs or the patient decides to withdraw from the study. Both arms of the study will undergo echocardiograms with contrast at baseline, upon completion of doxorubicin-containing cycles (within 28 days of completion), and at the one-year and seven-year time points. Additionally biomarker labs will be obtained to explore if there is a correlation between change in cardiac activity and the activity of metformin. If willing, all enrolled patients will provide a sample of whole blood for further exploratory analysis. Symptoms reported during the study will be correlated with know single nucleotide polymorphisms (SNPs) found during an exploratory genomic analysis.

Use of Metformin to Reduce Cardiac Toxicity in Breast Cancer

A Phase II Pilot Study Using Metformin to Reduce Cardiac Toxicity in Breast Cancer Patients

Determine whether the addition of metformin to standard doxorubicin therapy in breast cancer patients will decrease the incidence of change in left ventricle ejection fraction (LVEF).

Avera McKennan Hospital & University Health Center

Patients will receive standard of care for their breast cancer with no metformin during their treatment with doxorubicin.

Doxorubicin: Standard of care treatment with doxorubicin

Standard of Care

Patients will receive metformin during their treatment with doxorubicin for their breast cancer.

Metformin: Metformin will begin to be administered prior to treatment with doxorubicin. Metformin will continue to be given throughout doxorubicin cycles until the completion of doxorubicin therapy.

Doxorubicin: Standard of care treatment with doxorubicin

Metformin + Standard of Care

Total

Echocardiography

The study was terminated early due to slow accrual.

Stacy Kehoe

Number of Participants With Less Than or Equal to 5% Decrease in Left Ventricle Ejection Fraction (LVEF) on Echocardiogram

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Lymphoma, Large B-Cell, Diffuse

Lymphoma

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Lymphosarcoma

Antirheumatic Agents

Anti-Inflammatory Agents

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Cardiotonic Agents

Cyclophosphamide

Rituximab

Vincristine

Prednisolone

Lenalidomide

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Dexrazoxane

Razoxane

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Tubulin Modulators

Antimitotic Agents

Angiogenesis Inhibitors

Growth Inhibitors

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Protective Agents

Standard R-CHOP 21 treatment regimen:

6 cycles R-CHOP 21 (rituximab\*, cyclophosphamide, doxorubicin, vincristine, prednisolone)

\*The use of a biosimilar is allowed.

Addition of the cardioprotectant dexrazoxane to the R-CHOP 21 regimen:

R-CHOP21 (rituximab\*, cyclophosphamide, doxorubicin, vincristine, prednisolone plus dexrazoxane).

\*The use of a biosimilar is allowed.

Day 1 Cycle 1-6: Dexrazoxane 500 mg/m2 (iv) will be given 30 minutes before doxorubicin infusion and should be infused during 15 minutes.

Day 1 Cycle 1-6: 1.4 mg/m2 (max 2 mg) (iv)

Day 1-14 Cycle 1-6: 15 mg day (oral) Only in case of a double hit lymphoma.

6 mg (1 dose per cycle) in case of neutropenia. Pegfilgastim is mandatory in patients that receive R2-CHOP21.

Pegfilgrastim

A. van Rhenen, MD

M.P.M. Linschoten, MD

Patients treated for DLBCL are at high risk of developing AICD. This adverse event is characterized by irreversible damage to the heart muscle with a loss of cardiomyocytes and subsequent decline in cardiac pumping capacity. Thereby patients treated for this malignancy are at double the risk of developing symptomatic heart failure / cardiomyopathy when compared to the general population. This corresponds to a cumulative incidence of 5-10% within 5-years after receiving R-CHOP. In the elderly, an incidence of 26% has been reported after 8-years of follow-up. Among patients who die in complete remission, heart failure has been described to be one of the most important causes of death. ANTICIPATE aims to evaluate if dexrazoxane can prevent AICD in DLBCL patients and identify those at highest risk of AICD. Of all patients treated with anthracyclines in a first-line setting, DLBCL patients were chosen for this trial for two primary reasons. Firstly, these patients have a favourable oncological prognosis with a 5-year relative survival in the Netherlands of 64-78% in those aged 18-74 years increasing the importance of preventing long-term toxicity. Secondly, the cumulative anthracycline dose used for the treatment of DLBCL is higher than the dose used in breast cancer. The cumulative anthracycline dose is the most important risk factor for AICD known.

HO170 DLBCL-ANTICIPATE: "Prevention of ANThracycline-Induced Cardiac dysfunction by dexrazoxane In PATients with diffusE large B-cell lymphoma" is a national randomized controlled trial that will be conducted across 25 Dutch hospitals. This study will include adult patients with DLBCL in which first-line treatment with 6 cycles of R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) is planned (cumulative doxorubicin dose 300 mg/m2). In this trial, we have chosen to include patients with a normal cardiac function before chemotherapy because cardiac dysfunction is a contra-indication for administration of anthracyclines. A total of 324 DLBCL patients will prior to treatment be randomized in a 1:1 ratio to either (1) intravenous dexrazoxane administration in a 10:1 dexrazoxane:doxorubicin ratio prior to each doxorubicin infusion or (2) no cardioprotective treatment (current standard of care). Due to the low pH of the dexrazoxane solution that would jeopardize the blinding no placebo is used. Cardiac function will be screened with echocardiography prior to the initiation of chemotherapy and followed-up at 4- and 12-months post randomization. The primary end point of the study will be the incidence of AICD, defined as a left ventricular ejection fraction (LVEF) decline of ≥10 percentage points from baseline and below 50% (normal reference value for two-dimensional (2D) echocardiography). The secondary endpoint will be the percentage of patients with complete metabolic remission (CMR) after R-CHOP chemotherapy, to reassure that dexrazoxane does not influence the antineoplastic efficacy of doxorubicin. To declare ANTICIPATE successful, the trial must show both the superiority of addition of dexrazoxane on the primary endpoint and non-inferiority on the secondary endpoint. Deep-phenotyping of patient- and treatment-related factors will be performed to evaluate their prognostic value.

Prevention of Anthracycline-Induced Cardiac Dysfunction With Dexrazoxane in Patients With Diffuse Large-B Cell Lymphoma

ANTICIPATE: Prevention of ANThracycline-Induced Cardiac Dysfunction by Dexrazoxane In PATients With diffusE Large B-cell Lymphoma: a Phase III National Multicenter Prospective Randomized Open-label Trial

According to the current publication policy the protocol and Statistical Analysis Plan (SAP) will be shared. The Principal Investigators can be contacted for IPD sharing after the publication of the study results. According to the 'HOVON Sample and/or Data request Form' the HOVON director; chair of the lymphoma working group, the study PI and Coordinating Investigator should approve data/sample sharing.

Safety and toxicity as defined by type, frequency and severity of adverse events as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Major Adverse Cardiovascular Events (MACE) at 1-, 2-, 5- and 10-years.

The incidence of AICD (measured with 2D) within 12 months after registration.

Complete metabolic remission (CMR) on 18F-FDG PET-CT at end of treatment 6-8 weeks after completion of 6x R-CHOP21.

Progression-free survival (PFS) at 12-months.

LVEF (2D and 3D) and global longitudinal strain (GLS) at end of treatment and 12-months after start of treatment.

Release of cardiac biomarkers. At entry, after every cyle of R-CHOP, at EOT and FU. CK (if available); CK-MB (if available) \& (hs)Troponin T/I (assay according to local practice).

To analyse the impact of the addition of dexrazoxane on QoL via validated questionaires such as QLQ-C30, NHL-HG29, PRO-CTCAE.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
REcovery of Left Ventricular Dysfunction in CAncer Patients (RECAP Trial)	NCT02543294	Heart Failure Cancer Treatmen...	Echocardiograms Electrocardiogr... Symptom Questio... Telephone Follo...	18 Years -	M.D. Anderson Cancer Center
Use of Metformin to Reduce Cardiac Toxicity in Breast Cancer	NCT02472353	Breast Cancer Breast Tumors	Metformin Doxorubicin	21 Years -	Avera McKennan Hospital & University Health Center
Prevention of Anthracycline-Induced Cardiac Dysfunction With Dexrazoxane in Patients With Diffuse Large-B Cell Lymphoma	NCT06220032	DLBCL - Diffuse...	Dexrazoxane Rituximab Cyclophosphamid... Doxorubicin Vincristine Prednisolone Lenalidomide Pegfilgrastim	18 Years -	Stichting Hemato-Oncologie voor Volwassenen Nederland

Spots Global Cancer Trial Database for lvef

Every month we try and update this database with for lvef cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for lvef

Every month we try and update this database with for lvef cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for lvef cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.