REcovery of Left Ventricular Dysfunction in CAncer Patients (RECAP Trial)
27. januar 2020 oppdatert 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
20
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Texas
-
Houston, Texas, Forente stater, 77030
- University of Texas MD Anderson Cancer Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30.
Andre navn:
Electrocardiogram performed at baseline.
Andre navn:
Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30.
Andre navn:
Telephone follow-up by study staff at months 3 and 5.
|
|
Eksperimentell: 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.
|
Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30.
Andre navn:
Electrocardiogram performed at baseline.
Andre navn:
Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30.
Andre navn:
Telephone follow-up by study staff at months 3 and 5.
|
|
Eksperimentell: 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.
|
Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30.
Andre navn:
Electrocardiogram performed at baseline.
Andre navn:
Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30.
Andre navn:
Telephone follow-up by study staff at months 3 and 5.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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).
Tidsramme: 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;
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Risk Factors to Predict Early Decline of Myocardial Function During the Weaning of HF (Heart Failure) Medications.
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Anecita Fadol, PHD, MSN, M.D. Anderson Cancer Center
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
10. september 2012
Primær fullføring (Faktiske)
10. september 2017
Studiet fullført (Faktiske)
10. september 2017
Datoer for studieregistrering
Først innsendt
4. september 2015
Først innsendt som oppfylte QC-kriteriene
4. september 2015
Først lagt ut (Anslag)
7. september 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. februar 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. januar 2020
Sist bekreftet
1. januar 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2012-0379
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