- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02732990
Peripheral Metabolic Function in Chronic Heart Failure Patients
4. april 2016 oppdatert 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.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Forventet)
60
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Copenhagen, Danmark, 2100
- Rekruttering
- Centre of Inflammation and Metabolism (CIM), Centre for Physical Activity Research
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Ta kontakt med:
- Gregers W Munch, MSc PhD
- Telefonnummer: +45 35459574
- E-post: gregers.munch@regionh.dk
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
40 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change from baseline sympathetic nerve activity after 6 weeks of training
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The effect of exercise training on exercise capacity in regards to oxygen uptake
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studiestol: Stefan P Mortensen, Dr. Med, IMM - Department of Cardiovascular and Renal Research
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. februar 2014
Primær fullføring (Forventet)
1. august 2016
Studiet fullført (Forventet)
1. august 2016
Datoer for studieregistrering
Først innsendt
6. november 2014
Først innsendt som oppfylte QC-kriteriene
4. april 2016
Først lagt ut (Anslag)
11. april 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
11. april 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. april 2016
Sist bekreftet
1. april 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- VEK-H-3-2013-048
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .