Clinical worsening intervention for Heart Failure

University of Michigan, Ann Arbor, MI
Heart FailureClinical worsening intervention - Behavioral
Eligibility
18+
All Sexes

Study Summary

This trial will test two different ways of using a mobile app to help heart failure patients.

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

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Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 12 weeks

12 weeks
All-Cause Mortality [ Time Frame: Baseline up to Week 12 ]
Change from baseline in health-related quality of life [ Time Frame: Baseline, Week 12 ]
Heart failure-related hospitalizations [ Time Frame: Baseline to Week 12 ]
Hierarchical combination ("win ratio") of time to all-cause mortality, time to heart failure hospital readmission, and decline in health-related quality of life (HRQOL) [ Time Frame: Baseline up to Week 12 ]

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Bendroflumethiazide/ Amiloride
1
Bumetanide 1.25 mg
3
Autologous cell therapy

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4 Treatment Groups

Clinical Worsening Intervention
1 of 4
Dietary Sodium Intervention
1 of 4
Dietary Sodium and Clinical Worsening
1 of 4
Control Group
1 of 4

Experimental Treatment

Non-Treatment Group

62 Total Participants · 4 Treatment Groups

Primary Treatment: Clinical worsening intervention · Has Placebo Group · Phase 3

Clinical Worsening Intervention
Behavioral
Experimental Group · 1 Intervention: Clinical worsening intervention · Intervention Types: Behavioral
Dietary Sodium Intervention
Behavioral
Experimental Group · 1 Intervention: Sodium intervention · Intervention Types: Behavioral
Dietary Sodium and Clinical WorseningExperimental Group · 2 Interventions: Sodium intervention, Clinical worsening intervention · Intervention Types: Behavioral, Behavioral
Control Group
Behavioral
ShamComparator Group · 1 Intervention: Educational content · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,487 Previous Clinical Trials
5,129,686 Total Patients Enrolled
40 Trials studying Heart Failure
213,027 Patients Enrolled for Heart Failure
University of MichiganLead Sponsor
1,673 Previous Clinical Trials
6,422,209 Total Patients Enrolled
23 Trials studying Heart Failure
13,166 Patients Enrolled for Heart Failure
Michael Dorsch, PharmDPrincipal Investigator - University of Michigan
University of Michigan

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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

Who else is applying?

What state do they live in?
Missouri100.0%
How old are they?
65+100.0%
What site did they apply to?
Washington University in St. Louis100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References

Frequently Asked Questions

How many test subjects are required for this research?

"That is right, the online information indicates that this study is looking for 500 individuals to participate and it has 9 different locations. The original posting was on 6/14/2021 with the most recent update on 3/21/2022." - Anonymous Online Contributor

Unverified Answer

Where are patients able to take part in this trial?

"Currently, this study is operational at 9 sites. They are situated in Atlanta, Saint Louis and Detroit along with 6 other cities. If you choose to participate in this trial, try and select the location that is closest to you to reduce travel time." - Anonymous Online Contributor

Unverified Answer

Has the FDA given their blessing to this Clinical worsening intervention?

"There is existing clinical data that supports the efficacy of this intervention, and thus it has been given a safety score of 3." - Anonymous Online Contributor

Unverified Answer

Are there any available positions for patients who want to enroll in this clinical trial?

"That is correct. The clinicaltrials.gov website indicates that this trial is still actively looking for participants. This research was originally posted on June 14th, 2021 and was most recently updated on March 21st, 2022. Currently, they are trying to enroll 500 patients from 9 different locations." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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