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Peripheral Metabolic Function in Chronic Heart Failure Patients

4. april 2016 opdateret af: Anders Rasmussen Rinnov

Peripheral Metabolic Function in Chronic Heart Failure Patients: Key to Lessen the Cardiac Load

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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Danmark
      • Copenhagen, Danmark, 2100
        • Rekruttering
        • Centre of Inflammation and Metabolism (CIM), Centre for Physical Activity Research
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Exercise training - Whole body exercise
Control subjects will train 2-legged cycling (whole body exercise) for 6 weeks
Adfærdsmæssigt: Exercise training
All gruoups will undergo 6 weeks of training intervention either with a small musclemass (one-legged exercise) or whole body exercise (two-legged cycling)
Eksperimentel: Exercise training - One-legged exercise
Control subjects will train high intense one-legged exercise for 6 weeks
Adfærdsmæssigt: Exercise training
All gruoups will undergo 6 weeks of training intervention either with a small musclemass (one-legged exercise) or whole body exercise (two-legged cycling)
Eksperimentel: Exercise training - 2-legged cycling CHF
CHF patients will train 2-legged cycling (whole body exercise) for 6 weeks
Adfærdsmæssigt: Exercise training
All gruoups will undergo 6 weeks of training intervention either with a small musclemass (one-legged exercise) or whole body exercise (two-legged cycling)
Eksperimentel: Exercise training - CHF
CHF Patients will train high intense one-legged exercise for 6 weeks
Adfærdsmæssigt: Exercise training
All gruoups will undergo 6 weeks of training intervention either with a small musclemass (one-legged exercise) or whole body exercise (two-legged cycling)

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Anders Rasmussen Rinnov

Efterforskere

  • Studiestol: Stefan P Mortensen, Dr. Med, IMM - Department of Cardiovascular and Renal Research

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2014

Primær færdiggørelse (Forventet)

1. august 2016

Studieafslutning (Forventet)

1. august 2016

Datoer for studieregistrering

Først indsendt

6. november 2014

Først indsendt, der opfyldte QC-kriterier

4. april 2016

Først opslået (Skøn)

11. april 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. april 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. april 2016

Sidst verificeret

1. april 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • VEK-H-3-2013-048

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Placeringer

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