Brief Summary

This study will look at how pacing your heart may assist your daily activities and how you are feeling.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline

Completed

Started Jul 2008

Typical duration for not_applicable heart-failure

Geographic Reach

1 country

5 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3 years study duration

First Submitted

Initial submission to the registry

April 23, 2008

Completed

8 days until next milestone

First Posted

Study publicly available on registry

May 1, 2008

Completed

2 months until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed

3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed

5.9 years until next milestone

Results Posted

Study results publicly available

May 19, 2017

Completed

Last Updated

May 19, 2017

Status Verified

May 1, 2017

Enrollment Period

3 years

First QC Date

April 23, 2008

Results QC Date

May 3, 2012

Last Update Submit

May 17, 2017

Conditions

Heart Failure

Keywords

Heart failureexercise capacityejection fractionHeart failure normal ejection fraction

Outcome Measures

Primary Outcomes (1)

Peak Volume of Oxygen Uptake (Peak VO2) - Rate Adaptive Pacing (RAP) On at One Month vs. Rate Adaptive Pacing (RAP) Off at One Month.
Randomized therapy order cross-over comparison at 1 month post-implant. Each patient evaluated for endpoint with and without RAP therapy at this time.
1 month post implant

Secondary Outcomes (1)

Peak Volume of Oxygen Uptake (Peak VO2) - Rate Adaptive Pacing (RAP) On at Six Months vs. Rate Adaptive Pacing (RAP) Off at One Month.
6 months post implant

Study Arms (2)

RAP On then Off at 1 month visit

EXPERIMENTAL

1. Rate Adaptive Pacing (RAP) On for first cardiopulmonary exercise test (CPX) at one month. 2. Rate Adaptive Pacing (RAP) Off for second cardiopulmonary exercise test (CPX) at one month.

Device: Insignia Plus / Ultra (Guidant/Boston Scientific)

RAP Off then On at 1 month visit

EXPERIMENTAL

1. Rate Adaptive Pacing (RAP) Off for first cardiopulmonary exercise test (CPX) at one month. 2. Rate Adaptive Pacing (RAP) On for second cardiopulmonary exercise test (CPX) at one month.

Device: Insignia Plus / Ultra (Guidant/Boston Scientific)

Interventions

Insignia Plus / Ultra (Guidant/Boston Scientific)DEVICE

Cardiac pacing using any Guidant/Boston Scientific Implantable Pacemaker System with rate-modulation and any compatible intracardiac lead system.

Also known as: Guidant or Boston Scientific implantable pacemakers

RAP Off then On at 1 month visitRAP On then Off at 1 month visit

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients who are in sinus rhythm
Patients who are on stable medical therapy
Patients who exhibit signs and symptoms of heart failure, New York Heart Association (NYHA) Class II or III
Patients who have experienced a hospitalization for decompensated heart failure; treatment for pulmonary congestion or volume overload; chronic treatment with a loop diuretic; or a brain natriuretic peptide (BNP) \> 125 ng/l.
Left ventricular ejection fraction (LVEF) ≥ 50%

You may not qualify if:

Patients with persistent atrial fibrillation or atrial flutter
Patients who are in complete heart block
Patients who have experienced a recent myocardial infarction (MI) or have unstable angina or require cardiac surgery or other procedures
Patients who have severe heart valve disease or valve replacement
Patients with a contraindication for a pacemaker system
Patients who have a neuromuscular, orthopedic or other non-cardiac condition that prevents patient from exercise testing
Patients who have infiltrative or hypertrophic cardiomyopathy
Patients who have known severe pulmonary disease
Patients with uncontrolled diabetes or blood pressure (systolic blood pressure (SBP) \> 160 mmHg or diastolic blood pressure (DBP) \> 95 mmHg)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Boston Scientific Corporationlead

Study Sites (5)

Cardiovascular Associates of Northeast Arkansas

Jonesboro, Arkansas, 72401, United States

Location

Cardiovascular Associates

Louisville, Kentucky, 40205, United States

Location

Johns Hopkins Medical Institutions

Baltimore, Maryland, 21205, United States

Location

Mayo Clinic Foundation

Rochester, Minnesota, 55902, United States

Location

Tyler CV Consultants - Trinity Mother Frances

Tyler, Texas, 75701, United States

Location

Related Publications (1)

Kass DA, Kitzman DW, Alvarez GE. The restoration of chronotropic competence in heart failure patients with normal ejection fraction (RESET) study: rationale and design. J Card Fail. 2010 Jan;16(1):17-24. doi: 10.1016/j.cardfail.2009.08.008. Epub 2009 Oct 7.
PMID: 20123314BACKGROUND

MeSH Terms

Conditions

Heart FailureHeart Failure, Diastolic

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Limitations and Caveats

Early study termination leading to small numbers of subjects analyzed and an inability to test study hypothesis.

Results Point of Contact

Title: Elke Sommerijns
Organization: Boston Scientific

Study Officials

David A Kass, M.D.
Johns Hopkins University
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 23, 2008

First Posted

May 1, 2008

Study Start

July 1, 2008

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

May 19, 2017

Results First Posted

May 19, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing: Will not share

Locations

US(5)

Study Stopped

Restoration of Chronotropic Competence in Heart Failure Patients With Normal Ejection Fraction

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

RAP On then Off at 1 month visit

RAP Off then On at 1 month visit

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (5)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

RAP On then Off at 1 month visit

RAP Off then On at 1 month visit

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (5)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations