Heart FailureNCT06656715
Symptom Burden and Health Related Quality of Life of Cancer Patients With Concurrent Heart Failure
An observational study of Heart Failure, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To describe and compare the symptom burden in cancer patients with concurrent diagnosis of heart failure (HFrEF compared to HFpEF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2024to 1 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: We will approach cancer participants with solid tumors and with a concurrent diagnosis of heart failure who are followed at MD Anderson for HF management. In fiscal year 2023, of the more than 20,000 hospital discharges, approximately 6% of those discharges have a concurrent diagnosis of heart failure. Investigators will enroll 100 participants who meet the inclusion criteria.
Who may be able to join
- Age 18 years and older
- Individuals with a concurrent solid tumor cancer diagnosis
- Not receiving active cancer treatment except for those on maintenance (i.e., Selective ER modulators (SERMs)[Tamoxifen], Aromatase inhibitors (Anastrozole, Letrozole, Exemestane), Ovarian suppression therapy (GnRH Agonists [Leuprolide], Androgen deprivation therapy for prostate cancer
- Completed cancer treatment at least 3 months and up to 3 years before study enrollment.
- Therapy
- Able to read, speak and consent in English
Show all 9Show fewer
- Ability to understand and the willingness to sign a written informed consent document
- Diagnosis of heart failure, confirmed by echocardiogram, MUGA, or cardiac catheterization
- Internet access via smart phone, tablet, a computer, or another device with the capacity to 1) download the Fitbit App and 2) complete electronic study assessments via REDCap.
Who cannot join
- Participants undergoing active cancer treatment.
- Inability to provide consent in the medical record, such as cognitively impaired individuals.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas of MD Anderson Cancer Center
Houston, Texas, 77030
About this study
To describe and compare the symptom burden in cancer patients with concurrent diagnosis of heart failure (HFrEF compared to HFpEF).
Read the detailed description
The investigators will conduct a symptom assessment at study enrollment on cancer participants with a concurrent diagnosis of HF (HFrEF and HFpEF) using the MD Anderson Symptom Inventory- Heart Failure (MDASI-HF) and PROMIS Instruments (Fatigue, Dyspnea, and Sleep Disturbance).
The investigators will also describe and compare the health-related quality of life using the European Organization for Research and Training Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and the measure of Quality of Life Short Form-12 (SF-12).
- Conditions
- Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SingleArm | Symptom Assessment and Comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Failure
The investigators will conduct a symptom assessment at study enrollment on cancer participants with a concurrent diagnosis of HF (HFrEF and HFpEF) using the MD Anderson Symptom Inventory- Heart Failure (MDASI-HF) and PROMIS Instruments (Fatigue, Dyspnea, and Sleep Disturbance).
Measured: Through study completion, an average of 3 years
Heart Failure
The investigators will also describe and compare the health-related quality of life using the European Organization for Research and Training Quality- of-Life Questionnaire-Core 30 (EORTC QLQ-C30) and the Measure of Quality of Life Short Form-12 (SF-12).
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start16 Dec 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2028 (estimated)
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656715
- Sponsor's protocol ID
- 2024-1125
- Other IDs
- NCI-2024-07991
- Status last verified
- Jul 2026
- First submitted
- 11 Oct 2024
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Burden and Health Related Quality of Life of Cancer Patients With Concurrent Heart Failure
- ClinicalTrials.gov ID
- NCT06656715
- Acronym / sponsor ID
- 2024-1125
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 102 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 24 Oct 2024 (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.
To describe and compare the symptom burden in cancer patients with concurrent diagnosis of heart failure (HFrEF compared to HFpEF).
Detailed description
The investigators will conduct a symptom assessment at study enrollment on cancer participants with a concurrent diagnosis of HF (HFrEF and HFpEF) using the MD Anderson Symptom Inventory- Heart Failure (MDASI-HF) and PROMIS Instruments (Fatigue, Dyspnea, and Sleep Disturbance).
The investigators will also describe and compare the health-related quality of life using the European Organization for Research and Training Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and the measure of Quality of Life Short Form-12 (SF-12).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SingleArm | – | –Symptom Assessment and Comparison |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will approach cancer participants with solid tumors and with a concurrent diagnosis of heart failure who are followed at MD Anderson for HF management. In fiscal year 2023, of the more than 20,000 hospital discharges, approximately 6% of those discharges have a concurrent diagnosis of heart failure. Investigators will enroll 100 participants who meet the inclusion criteria.
Key inclusion criteria (9 listed)
- Age 18 years and older
- Individuals with a concurrent solid tumor cancer diagnosis
- Not receiving active cancer treatment except for those on maintenance (i.e., Selective ER modulators (SERMs)[Tamoxifen], Aromatase inhibitors (Anastrozole, Letrozole, Exemestane), Ovarian suppression therapy (GnRH Agonists [Leuprolide], Androgen deprivation therapy for prostate cancer
- Completed cancer treatment at least 3 months and up to 3 years before study enrollment.
- Therapy
Key exclusion criteria (2 listed)
- Participants undergoing active cancer treatment.
- Inability to provide consent in the medical record, such as cognitively impaired individuals.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Heart Failure
Time frame: Through study completion, an average of 3 years
The investigators will conduct a symptom assessment at study enrollment on cancer participants with a concurrent diagnosis of HF (HFrEF and HFpEF) using the MD Anderson Symptom Inventory- Heart Failure (MDASI-HF) and PROMIS Instruments (Fatigue, Dyspnea, and Sleep Disturbance).
Heart Failure
Time frame: Through study completion, an average of 3 years
The investigators will also describe and compare the health-related quality of life using the European Organization for Research and Training Quality- of-Life Questionnaire-Core 30 (EORTC QLQ-C30) and the Measure of Quality of Life Short Form-12 (SF-12).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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A Study of Bimagrumab in Participants With HFpEF
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Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
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Assessment of Combined CCM and ICD Device in HFrEF
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RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by M.D. Anderson Cancer Center at 1 site in United States.
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 9 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Heart Failure (time frame: Through study completion, an average of 3 years). The study lists 2 primary outcomes in all. 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 14 Jul 2026.