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Procedure

PITA for Heart Failure

N/A
Waitlist Available
Led By Kavita Sharma, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights

Study Summary

This trial is testing a new treatment for heart failure called pacemaker induced transient dyssynchrony (PITA). This treatment involves using a pacemaker to purposely induce dyssynchrony (abnormal electrical impulse propagation) for several hours each day and then reversing this for the remainder of the time. The trial will test the feasibility, safety, and tolerability of PITA in humans with dilated cardiomyopathy. If successful, this study could lead to a larger study to assess the effectiveness of PITA in treating heart failure.

Eligible Conditions
  • Heart Failure
  • Dilated Cardiomyopathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility as assessed by percent ventricular capture through Holter monitoring
Safety as assessed by number of arrhythmia episodes via device interrogation
Safety as assessed by number of tachytherapies delivered by ICDs
+7 more
Secondary outcome measures
Change in N-terminal pro b-type natriuretic peptide (NT pro-BNP) values
Change in serum blood urea nitrogen (BUN) values
Change in serum creatinine values (mg/dL)
+3 more
Other outcome measures
Change in left ventricular (LV) chamber dimensions
Change in left ventricular (LV) ejection fraction

Trial Design

1Treatment groups
Experimental Treatment
Group I: PITA ParticipantsExperimental Treatment1 Intervention
All patients in the study are part of the "PITA" arm, where PITA will be on for Weeks 0-8, and off from Weeks 8-12.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PITA
2020
N/A
~10

Find a Location

Who is running the clinical trial?

MedtronicIndustry Sponsor
610 Previous Clinical Trials
828,731 Total Patients Enrolled
90 Trials studying Heart Failure
90,786 Patients Enrolled for Heart Failure
Johns Hopkins UniversityLead Sponsor
2,274 Previous Clinical Trials
14,840,510 Total Patients Enrolled
21 Trials studying Heart Failure
4,762 Patients Enrolled for Heart Failure
Kavita Sharma, MDPrincipal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
60 Total Patients Enrolled
1 Trials studying Heart Failure
60 Patients Enrolled for Heart Failure
~2 spots leftby Jun 2025
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