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

27 januari 2020 uppdaterad av: M.D. Anderson Cancer Center
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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

20

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Texas
      • Houston, Texas, Förenta staterna, 77030
        • University of Texas MD Anderson Cancer Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  1. Cancer survivors with no evidence of disease for at least 6 months as determined by the oncologist and no longer receiving cancer treatment.
  2. 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).
  3. Absence of other causes of cardiomyopathy (e.g. ischemia, hypertension, amyloidosis, or hemochromatosis) per chart review of the clinician's documentation
  4. Documented normal LVEF for at least 6 months after the initiation of recommended HF therapy.
  5. 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.
  6. Residence within the United States.
  7. 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.

Exclusion Criteria:

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Anthracycline Treatment Group
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.
Enhet: Echocardiograms
Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30.
Andra namn:
  • EKO
Enhet: Electrocardiogram
Electrocardiogram performed at baseline.
Andra namn:
  • EKG
Beteende: Symptom Questionnaire
Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30.
Andra namn:
  • Undersökning
Beteende: Telephone Follow-Up
Telephone follow-up by study staff at months 3 and 5.
Experimentell: Herceptin Treatment Group
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.
Enhet: Echocardiograms
Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30.
Andra namn:
  • EKO
Enhet: Electrocardiogram
Electrocardiogram performed at baseline.
Andra namn:
  • EKG
Beteende: Symptom Questionnaire
Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30.
Andra namn:
  • Undersökning
Beteende: Telephone Follow-Up
Telephone follow-up by study staff at months 3 and 5.
Experimentell: Combination of Treatments Group
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.
Enhet: Echocardiograms
Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30.
Andra namn:
  • EKO
Enhet: Electrocardiogram
Electrocardiogram performed at baseline.
Andra namn:
  • EKG
Beteende: Symptom Questionnaire
Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30.
Andra namn:
  • Undersökning
Beteende: Telephone Follow-Up
Telephone follow-up by study staff at months 3 and 5.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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).
Tidsram: 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.
A total of 30 months from enrollment date of each participant;

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

M.D. Anderson Cancer Center

Utredare

  • Huvudutredare: Anecita Fadol, PHD, MSN, M.D. Anderson Cancer Center

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

10 september 2012

Primärt slutförande (Faktisk)

10 september 2017

Avslutad studie (Faktisk)

10 september 2017

Studieregistreringsdatum

Först inskickad

4 september 2015

Först inskickad som uppfyllde QC-kriterierna

4 september 2015

Första postat (Uppskatta)

7 september 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 februari 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 januari 2020

Senast verifierad

1 januari 2020

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2012-0379

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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