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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 months

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

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Who is running the clinical trial?

MedtronicIndustry Sponsor

607 Previous Clinical Trials

828,667 Total Patients Enrolled

90 Trials studying Heart Failure

90,786 Patients Enrolled for Heart Failure

Johns Hopkins UniversityLead Sponsor

2,267 Previous Clinical Trials

14,837,599 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate population size that has joined this trial?

"Affirmative. According to the details posted on clinicaltrials.gov, this medical investigation has begun accepting participants since November 20th 2020 and is still looking for new candidates. They are targeting 8 individuals at a single site."

Answered by AI

What is the principal goal of this clinical research initiative?

"As outlined by Medtronic, the main metric of success in this trial will be Tolerability as assessed via Sleep Quality and monitored over Baseline, Week 4, Week 8, and Week 12. Secondary objectives include quantifying dyssynchrony on echocardiography with an emphasis on interventricular/intraventricular discordance of QRS-complexes to peak pulmonary or aortic valve inflow >40 ms; septal-to-posterior wall motion delay higher than 130 milliseconds; onset/peak systolic velocity of opposing LV walls greater than 65ms; change in sodium levels ("

Answered by AI

Are new participants welcomed for this medical trial?

"The evidence sourced from clinicaltrials.gov suggests that the recruitment process for this investigation is ongoing, having first been posted on November 20th 2020 and last updated on December 7th 2022."

Answered by AI

Recent research and studies

CirculationJournal

Heart Disease and Stroke Statistics—2019 Update: A Report from the American Heart Association

Benjamin, Emelia J., Paul Muntner, Alvaro Alonso, Marcio S. Bittencourt, Clifton W. Callaway, April P. Carson, Alanna M. Chamberlain, et al.. 2019. “Heart Disease and Stroke Statistics—2019 Update: A Report from the American Heart Association”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/cir.0000000000000659.

Journal of the American College of CardiologyJournal

Noninvasive Single-beat Determination of Left Ventricular End-systolic Elastance in Humans

Chen, Chen-Huan, Barry Fetics, Erez Nevo, Carlos E. Rochitte, Kuan-Rau Chiou, PhillipYu-An Ding, Miho Kawaguchi, and David A. Kass. 2001. “Noninvasive Single-beat Determination of Left Ventricular End-systolic Elastance in Humans”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/s0735-1097(01)01651-5.

Journal of the American College of CardiologyJournal

High Incidence of Pacemaker Syndrome in Patients with Sinus Node Dysfunction Treated with Ventricular-based Pacing in the Mode Selection Trial (MOST)

Link, Mark S, Anne S Hellkamp, N.A.Mark Estes III, E.John Orav, Kenneth A Ellenbogen, Bassiema Ibrahim, Arnold Greenspon, et al.. 2004. “High Incidence of Pacemaker Syndrome in Patients with Sinus Node Dysfunction Treated with Ventricular-based Pacing in the Mode Selection Trial (MOST)”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2003.10.072.

Heart Failure ClinicsJournal