- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02732990
Peripheral Metabolic Function in Chronic Heart Failure Patients
4 april 2016 uppdaterad av: 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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
60
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Copenhagen, Danmark, 2100
- Rekrytering
- Centre of Inflammation and Metabolism (CIM), Centre for Physical Activity Research
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Kontakt:
- Gregers W Munch, MSc PhD
- Telefonnummer: +45 35459574
- E-post: gregers.munch@regionh.dk
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
40 år till 70 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Exercise training - Whole body exercise
Control subjects will train 2-legged cycling (whole body exercise) for 6 weeks
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All gruoups will undergo 6 weeks of training intervention either with a small musclemass (one-legged exercise) or whole body exercise (two-legged cycling)
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Experimentell: Exercise training - One-legged exercise
Control subjects will train high intense one-legged exercise for 6 weeks
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All gruoups will undergo 6 weeks of training intervention either with a small musclemass (one-legged exercise) or whole body exercise (two-legged cycling)
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Experimentell: Exercise training - 2-legged cycling CHF
CHF patients will train 2-legged cycling (whole body exercise) for 6 weeks
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All gruoups will undergo 6 weeks of training intervention either with a small musclemass (one-legged exercise) or whole body exercise (two-legged cycling)
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Experimentell: Exercise training - CHF
CHF Patients will train high intense one-legged exercise for 6 weeks
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All gruoups will undergo 6 weeks of training intervention either with a small musclemass (one-legged exercise) or whole body exercise (two-legged cycling)
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change from baseline sympathetic nerve activity after 6 weeks of training
Tidsram: 6 weeks
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Sympathetic nerve activity, measured in plasma and dialysat with reference to nor-adrenaline.
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6 weeks
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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The effect of exercise training on exercise capacity in regards to oxygen uptake
Tidsram: 6 weeks
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Exercise capacity in regards to oxygen uptake (VO2peak) will be evaluated before and after the training intervention
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6 weeks
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The effect of exercise training on exercise capacity in regards to maximal workload
Tidsram: 6 weeks
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Exercise capacity in regards to Workload during 2-legged cycling (Wattpeak) will be evaluated before and after the training intervention
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6 weeks
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The effect of exercise training on exercise capacity in regards to a 6 min walk test
Tidsram: 6 weeks
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Exercise capacity in regards to a 6 min walk test (meters) will be evaluated before and after the training intervention
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6 weeks
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studiestol: Stefan P Mortensen, Dr. Med, IMM - Department of Cardiovascular and Renal Research
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 februari 2014
Primärt slutförande (Förväntat)
1 augusti 2016
Avslutad studie (Förväntat)
1 augusti 2016
Studieregistreringsdatum
Först inskickad
6 november 2014
Först inskickad som uppfyllde QC-kriterierna
4 april 2016
Första postat (Uppskatta)
11 april 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
11 april 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 april 2016
Senast verifierad
1 april 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- VEK-H-3-2013-048
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .