Efficacy Study of Pacemakers to Treat Slow Heart Rate in Patients With Heart Failure

Heart Failure, Diastolic Clinical Trial

— RAPID-HF  

Official title:

Rate-Adaptive Atrial Pacing In Diastolic Heart Failure (RAPID-HF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02145351
• Other study ID #: 13-008306
• Status: Completed
• Phase: N/A
• Start date: April 7, 2014
• Est. completion date: May 9, 2022

Study information

• Verified date: March 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Determine the impact of restoring normal heart rate response during exercise and daily activity in patients with heart failure and a preserved ejection fraction (HFpEF) and chronotropic incompetence (CI).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 9, 2022
• Est. primary completion date: May 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

1. Age >18 years and able to provide informed consent to enroll in the trial, or consent through a legal guardian or power of attorney.

2. Previous clinical diagnosis of HF with current NYHA Class II-III symptoms

3. At least one of the following: Hospitalization for decompensated HF, Acute treatment for HF with intravenous loop diuretic or hemofiltration, Chronic treatment with a loop diuretic for control of HF symptoms + left atrial enlargement on echocardiography or E/e' ratio (=14 average, =15 septal ) on echocardiography, Resting PCWP >15 mm Hg or LV end-diastolic pressure >18 mmHg at catheterization for dyspnea and/or exercise PCWP/LV end-diastolic pressure >25 mmHg, or Elevated NT-proBNP level (=300 pg/ml )

4. Left ventricular EF =40% within 12 months with clinical stability

5. Stable cardiac medical therapy for =30 days

6. Sinus rhythm

7. Chronotropic incompetence on recent (within 6 months) clinical or screening exercise test, defined as heart rate reserve (HRR) <0.80 or <0.62 if on beta blockers

8. Meet both screening criteria on clinically-performed cardiopulmonary exercise testing within 12 months.

Exclusion Criteria

1. Inability to exercise, or non-cardiac condition that precludes exercise testing

2. Any contraindication to a pacemaker system

3. Non-cardiac condition limiting life expectancy to less than one year

4. Significant left sided structural valve disease (>mild stenosis, >moderate regurgitation)

5. Hypertrophic cardiomyopathy

6. Infiltrative or inflammatory myocardial disease (amyloid, sarcoid)

7. Pericardial disease

8. Non-group 2 pulmonary arterial hypertension

9. Chronic stable exertional angina

10. Acute coronary syndrome or revascularization within 60 days

11. Other clinically important causes of dyspnea

12. Atrial fibrillation

13. PR interval >210 msec

14. Resting heart rate (HR) > 100 bpm

15. A history of reduced ejection fraction (EF<40%)

16. Advanced chronic kidney disease (GFR < 20 ml/min/1.73m2 by modified MDRD equation)

17. Women of child bearing potential without negative pregnancy test and effective contraception

18. Severe anemia (Hemoglobin <10 g/dL)

19. Severe hepatic disease

20. Complex congenital heart disease

21. Listed for cardiac transplantation

22. Other class I indications for pacing

Related Conditions & MeSH terms

• Chronotropic Incompetence
• Heart Failure
• Heart Failure With a Preserved Ejection Fraction
• Heart Failure, Diastolic

Intervention

Device:
• Rate adaptive atrial pacing using a dual-chamber pacemaker
The Azure XT DR is a permanent, dual-chamber cardiac pacemaker with the ability to continuously monitor and record patient activity, and respond to activity by pacing faster and increasing the heart rate (rate adaptive atrial pacing). It will be programmed in AAIR mode to pace the right atrium. The leads will be placed in the right atrium and right ventricle using CapSureFix model 5086.
• Pacemaker system will be implanted but set to Pacing Off.
The identical pacing system will be implanted, but will be set to Pacing Off.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean Peak Heart Rate (HR)	Determined as the maximum heart rate . Heart rate (or pulse rate) is the frequency of the heartbeat measured by the number of contractions of the heart per minute (beats per minute, or bpm).	4 weeks
Primary	Change in Oxygen Consumption (VO2) at Ventilatory Anaerobic Threshold (VAT)	Maximal effort cardiopulmonary exercise testing was performed on a treadmill after 4 weeks of pacing-on and after 4 weeks of pacing-off to measure volumes of oxygen consumed (VO2). Change in VO2 at anaerobic threshold (VO2,AT) determined by the V-Slope method as the point of disproportionate rise in VCO2 relative to VO2 as measured in ml/kg/min.	baseline, after 4 weeks of treatment
Secondary	Peak Aerobic Capacity (Peak VO2)	Determined as the mean of values obtained over the final 30 seconds of exercise. Maximal effort cardiopulmonary exercise testing was performed on a treadmill after 4 weeks of pacing-on and after 4 weeks of pacing-off to measure volumes of oxygen consumed (VO2). As measured in ml/kg/min.	4 weeks after pacemaker activation
Secondary	Ventilatory Efficiency (VE/VCO2)	Determined as the nadir of VE/VCO2 ratio during exercise. Maximal effort cardiopulmonary exercise testing was performed on a treadmill after 4 weeks of pacing-on and after 4 weeks of pacing-off to measure volumes of oxygen consumed (VO2).	4 weeks
Secondary	Change in Plasma N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)	Change in plasma NT-proBNP as measured in pg/mL. Natriuretic peptides are substances made by the heart. A main type of these substances is NT-proBNP. Elevated levels can mean the heart isn't pumping as much blood the body needs.	baseline, after 4 weeks of treatment
Secondary	Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score	Change from baseline in KCCQ-overall summary score was reported. KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. KCCQ- overall summary score was average of domains- physical limitation, total symptoms (average of symptom frequency and symptom burden), quality of life, and social limitation, and transformed to a single score which ranged from 0 (worst) -100 (the best possible status), where the higher score reflected better health status.	baseline, after 4 weeks of treatment

External Links

•   Mayo Clinic Clinical Trials