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Peripheral Metabolic Function in Chronic Heart Failure Patients

Primary Purpose

Chronic Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Exercise training
Sponsored by
Anders Rasmussen Rinnov
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Heart Failure focused on measuring Training, One-legged exercise, Peripheral blood flow, Cardiac function, Muscle metaboreflex

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • New York Heart Association (NYHA) Class II - III
  • Ejection fraction <35%
  • Heart failure as a result of previous myocardial infarction
  • Optimal treatment (ACE-inhibitors, beta-blockers)
  • Stable heart failure
  • Patients with and without implantable cardioverter defibrillator (ICD)

Exclusion Criteria:

  • Peripheral vascular disease with symptoms of atherosclerosis (intermittent claudication)
  • Aneurysm in a. femoral
  • Moderate to severe heart valve disease
  • Moderate to severe Chronic Obstructive Pulmonary Disease (COPD) with FEV1 <60%
  • Heart Failure Patients with Biventricular pacemaker (BVP)
  • Serious heart rhythm disturbances (arrhythmias such as atrial fibrillation and frequent premature ventricular contractions)
  • Myocardial infarction within the last month
  • Unstable angina (angina pectoris)
  • Renal failure (creatinine greater than 2.5 mg / dL)
  • Severe systemic disease of the nervous system, pulmonary or other severe organ involvement
  • BMI> 30
  • Pregnancy

Sites / Locations

  • Centre of Inflammation and Metabolism (CIM), Centre for Physical Activity ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Exercise training - Whole body exercise

Exercise training - One-legged exercise

Exercise training - 2-legged cycling CHF

Exercise training - CHF

Arm Description

Control subjects will train 2-legged cycling (whole body exercise) for 6 weeks

Control subjects will train high intense one-legged exercise for 6 weeks

CHF patients will train 2-legged cycling (whole body exercise) for 6 weeks

CHF Patients will train high intense one-legged exercise for 6 weeks

Outcomes

Primary Outcome Measures

Change from baseline sympathetic nerve activity after 6 weeks of training
Sympathetic nerve activity, measured in plasma and dialysat with reference to nor-adrenaline.

Secondary Outcome Measures

The effect of exercise training on exercise capacity in regards to oxygen uptake
Exercise capacity in regards to oxygen uptake (VO2peak) will be evaluated before and after the training intervention
The effect of exercise training on exercise capacity in regards to maximal workload
Exercise capacity in regards to Workload during 2-legged cycling (Wattpeak) will be evaluated before and after the training intervention
The effect of exercise training on exercise capacity in regards to a 6 min walk test
Exercise capacity in regards to a 6 min walk test (meters) will be evaluated before and after the training intervention

Full Information

First Posted
November 6, 2014
Last Updated
April 4, 2016
Sponsor
Anders Rasmussen Rinnov
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1. Study Identification

Unique Protocol Identification Number
NCT02732990
Brief Title
Peripheral Metabolic Function in Chronic Heart Failure Patients
Official Title
Peripheral Metabolic Function in Chronic Heart Failure Patients: Key to Lessen the Cardiac Load
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anders Rasmussen Rinnov

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Exercise intolerance is a major limiting symptom in patients with CHF. However the poor correlation between the hemodynamic parameters of left ventricular performance at rest and exercise performance has led to the concept that peripheral factors such as muscle perfusion and muscle metabolism play a role as determinants of exercise capacity.
Detailed Description
The pathophysiology behind the breathlessness and fatigue experienced by CHF patients during exercise remains unclear. Recent evidence suggests that the peripheral skeletal muscle, which becomes abnormal in heart failure, is the source of afferent signals which disrupt normal patterns of cardiorespiratory control. When CHF patients exercise, an inappropriately strong sympathetic response further limits exercise tolerance by evoking larger than normal increases in peripheral sympathetic activation at a faster rate than in healthy individuals. A consequence of this exacerbated sympathetic response may be the further sympathetic restraint of blood flow to the active skeletal muscles resulting in hypoperfusion of the muscle vascular bed and fatigue. Small muscle mass exercise training increases muscle oxidative capacity and improves aerobic work capacity in CHF patients. A range of studies is proposed here that will provide an integrative view of the mechanistic basis behind exercise intolerance in CHF and relate the intramuscular metabolic status to the autonomic control of hemodynamics during exercise. An understanding of the mechanistic basis of the improved exercise tolerance with training, independent of improved resting cardiac function, will yield important information regarding the integrated control of blood flow and metabolic demand in CHF and highlight the importance of maintaining the integrity of the peripheral musculature in CHF.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
Training, One-legged exercise, Peripheral blood flow, Cardiac function, Muscle metaboreflex

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise training - Whole body exercise
Arm Type
Experimental
Arm Description
Control subjects will train 2-legged cycling (whole body exercise) for 6 weeks
Arm Title
Exercise training - One-legged exercise
Arm Type
Experimental
Arm Description
Control subjects will train high intense one-legged exercise for 6 weeks
Arm Title
Exercise training - 2-legged cycling CHF
Arm Type
Experimental
Arm Description
CHF patients will train 2-legged cycling (whole body exercise) for 6 weeks
Arm Title
Exercise training - CHF
Arm Type
Experimental
Arm Description
CHF Patients will train high intense one-legged exercise for 6 weeks
Intervention Type
Behavioral
Intervention Name(s)
Exercise training
Intervention Description
All gruoups will undergo 6 weeks of training intervention either with a small musclemass (one-legged exercise) or whole body exercise (two-legged cycling)
Primary Outcome Measure Information:
Title
Change from baseline sympathetic nerve activity after 6 weeks of training
Description
Sympathetic nerve activity, measured in plasma and dialysat with reference to nor-adrenaline.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
The effect of exercise training on exercise capacity in regards to oxygen uptake
Description
Exercise capacity in regards to oxygen uptake (VO2peak) will be evaluated before and after the training intervention
Time Frame
6 weeks
Title
The effect of exercise training on exercise capacity in regards to maximal workload
Description
Exercise capacity in regards to Workload during 2-legged cycling (Wattpeak) will be evaluated before and after the training intervention
Time Frame
6 weeks
Title
The effect of exercise training on exercise capacity in regards to a 6 min walk test
Description
Exercise capacity in regards to a 6 min walk test (meters) will be evaluated before and after the training intervention
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: New York Heart Association (NYHA) Class II - III Ejection fraction <35% Heart failure as a result of previous myocardial infarction Optimal treatment (ACE-inhibitors, beta-blockers) Stable heart failure Patients with and without implantable cardioverter defibrillator (ICD) Exclusion Criteria: Peripheral vascular disease with symptoms of atherosclerosis (intermittent claudication) Aneurysm in a. femoral Moderate to severe heart valve disease Moderate to severe Chronic Obstructive Pulmonary Disease (COPD) with FEV1 <60% Heart Failure Patients with Biventricular pacemaker (BVP) Serious heart rhythm disturbances (arrhythmias such as atrial fibrillation and frequent premature ventricular contractions) Myocardial infarction within the last month Unstable angina (angina pectoris) Renal failure (creatinine greater than 2.5 mg / dL) Severe systemic disease of the nervous system, pulmonary or other severe organ involvement BMI> 30 Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gregers W Munch, MSc PhD
Phone
+45 35459574
Email
gregers.munch@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan P Mortensen, Dr. Med
Organizational Affiliation
IMM - Department of Cardiovascular and Renal Research
Official's Role
Study Chair
Facility Information:
Facility Name
Centre of Inflammation and Metabolism (CIM), Centre for Physical Activity Research
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregers W Munch, MSc PhD
Phone
+45 35459574
Email
gregers.munch@regionh.dk

12. IPD Sharing Statement

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Peripheral Metabolic Function in Chronic Heart Failure Patients

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