All > Heart Failure With Preserved Ejection Fraction > Heart Failure

Usual Care for Heart Failure

Phase-Based Progress Estimates

Effectiveness

Safety

Heart Failure

Usual Care - Other

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Eligibility

18+

All Sexes

What conditions do you have?

Select

Eligibility

18+

All Sexes

What conditions do you have?

Select

Study Summary

This trial is testing whether cancer survivors who receive education and training about exercise are more likely to change their lifestyle and improve symptoms of heart failure.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Heart Failure

BAY2413555 Dose 2

Sacubitril-valsartan

sacubitril/valsartan

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 1 Year

1 Year

Recruitment/Attendance/Drop-Out Rates

Trial Safety

Safety Progress

1 of 3

Other trials for Heart Failure

BAY2413555 Dose 2

Sacubitril-valsartan

sacubitril/valsartan

Side Effects for

Loperamide - Education Only

38%Constipation

10%Urinary tract infection

8%Fall

8%Abdominal pain

7%Diarrhoea

7%Abdominal distension

6%Nausea

6%Back pain

6%Headache

3%Upper respiratory tract infection

2%Osteoarthritis

1%Ventricular tachycardia

1%Haemorrhoids

1%Hyperglycaemia

1%Ankle fracture

1%Pulmonary embolism

1%Chronic obstructive pulmonary disease

1%Anaemia

1%Vascular pseudoaneurysm

1%Transient ischaemic attack

1%Pancreatitis

This histogram enumerates side effects from a completed 2016 Phase 3 trial (NCT02008565) in the Loperamide - Education Only ARM group. Side effects include: Constipation with 38%, Urinary tract infection with 10%, Fall with 8%, Abdominal pain with 8%, Diarrhoea with 7%.

Trial Design

1 Treatment Group

Group 2

1 of 1

Experimental Treatment

85 Total Participants · 1 Treatment Group

Primary Treatment: Usual Care · No Placebo Group · N/A

Group 2Experimental Group · 3 Interventions: Usual Care, Dietary Counseling, Exercise Training · Intervention Types: Other, Behavioral, Behavioral

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dietary Counseling

2011

Completed Phase 3

~1860

Exercise Training

2011

Completed Phase 3

~1430

Trial Logistics

Trial Timeline

Approximate Timeline

Screening: ~3 weeks

Treatment: Varies

Reporting: 1 year

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,779 Previous Clinical Trials

1,784,678 Total Patients Enrolled

6 Trials studying Heart Failure

232 Patients Enrolled for Heart Failure

Karen Basen-Engquist, PhDPrincipal InvestigatorM.D. Anderson Cancer Center

5 Previous Clinical Trials

2,526 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:

You are living in the Houston area (Harris county or a contiguous county), or planning to stay in the area for at least the next 16 weeks.

You have received chemotherapy that contributed to the development of heart failure.

You are 18 years of age or older.

About The Reviewer

Michael Gill - B. Sc.

First Published: October 20th, 2021

Last Reviewed: October 26th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References