Interval Training and Hormones in Chronic Heart Failure

NCT02322034 | Unknown DMC

• 1 other identifier: UNINA-34/13
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim at investigating whether 24-week high intensity interval training might exert beneficial effects by modulating neurohormonal axis in patients with chronic heart failure (CHF). Furthermore, the effect of detraining on neurohormonal axis in CHF patients will be evaluated.

Conditions

Chronic Heart Failure

Keywords

chronic heart failure; multiple neurohormonal axis disequilibrium; growth hormone deficiency; Insulin-like growth factor-1 (IGF-1); metabolic deficiency syndrome; interval training

Outcome Measures

Primary Outcomes (1)

• peak exercise oxygen consumption (VO2peak)

  cardiopulmonary functional capacity

  24 weeks

Secondary Outcomes (2)

• growth hormone (GH) - insulin-like growth factor-1 (IGF-1)

  24-week

• brain natriuretic peptide

  24-week

Study Arms (2)

Interval Training

EXPERIMENTAL

Hospital outpatient-based regimen (3 times/week for 24 weeks) exercise program will be performed by cycling for 4 minutes with 1-minute rest between intervals. High intensity exercise will be 90-95% peak heart rate. The exercise intensity will be established, and maintained throughout the 24-week exercise training period, by calculating the heart rate range as a percentage of maximum (90-95%) as obtained from the most recent cardiopulmonary exercise test. Every 4 weeks during the training program, the exercise intensity will be titrated to the same relative percentage of maximum (90-95%) as it is assumed most patients will become fitter over the training period.

Other: Interval Training

Controls

NO INTERVENTION

CHF patients allocated to the control group (no intervention) will undergo biochemical and hormonal sampling, Doppler-echocardiography, cardiopulmonary exercise stress testing at study enrollment and at 24-week follow-up.

Interventions

Interval Training OTHER

Exercise training protocol (high intensity, interval training) is followed by the enrolled patients on hospital outpatient-based regimen 3 times/week for 24 weeks. The high intensity group will perform interval cycling for 4 minutes with 1-minute rest between intervals. High intensity exercise will be 90-95% peak heart rate. The exercise intensity will be established, and maintained throughout the 24-week exercise training period, by calculating the heart rate range as a percentage of maximum (90-95%) as obtained from the most recent cardiopulmonary exercise test. Every 4 weeks during the training program, the exercise intensity will be titrated to the same relative percentage of maximum (90-95%) as it is assumed most patients will become fitter over the training period.

Also known as: High Intensity Training, Intermittent Training

Interval Training

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Stable New York Heart Association (NYHA) class II or III
• Resting left ventricular ejection fraction below 40%
• Measured peak VO2 below 14 ml/kg/min \[Patients must be stable on prescribed cardiac medication for 1 month prior to entering the study\]

You may not qualify if:

• myocardial infarction within 12 months prior to study entry;
• unstable angina; resting systolic blood pressure above 200 mmHg, or diastolic blood pressure above 110 mmHg;
• fever of unknown significance;
• critical aortic stenosis (peak systolic pressure gradient \> 50 mm Hg with an aortic valve orifice area \< 0.75 cm2 in average size adult);
• uncontrolled atrial or ventricular arrhythmias such as uncontrolled sinus tachycardia (\> 120 beats.min-1);
• II or greater atrio-ventricular block;
• active pericarditis or myocarditis;
• recent embolism and thrombophlebitis;
• uncontrolled diabetes HbA1C%\>9.5%;
• severe orthopedic or other medical conditions that would prohibit exercise;
• metabolic conditions such as acute thyroiditis, hypokalemia or hyperkalemia and hypovolemia;
• severe renal dysfunction (i.e. creatinine plasma levels \>2.5 mg/dl);
• severe concomitant non-cardiac diseases such as cancer, dementia or any systemic disease limiting exercise;
• inability to participate in a prospective study for any logistic reason

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Division of Internal Medicine and Cardiac Rehabilitation

Naples, 80131, Italy

RECRUITING

Related Publications (13)

• Arcopinto M, Isgaard J, Marra AM, Formisano P, Bossone E, Vriz O, Vigorito C, Sacca L, Douglas PS, Cittadini A. IGF-1 predicts survival in chronic heart failure. Insights from the T.O.S.CA. (Trattamento Ormonale Nello Scompenso CArdiaco) registry. Int J Cardiol. 2014 Oct 20;176(3):1006-8. doi: 10.1016/j.ijcard.2014.07.003. Epub 2014 Jul 11. No abstract available.

  PMID: 25037691 BACKGROUND

• Isgaard J, Arcopinto M, Karason K, Cittadini A. GH and the cardiovascular system: an update on a topic at heart. Endocrine. 2015 Feb;48(1):25-35. doi: 10.1007/s12020-014-0327-6. Epub 2014 Jun 28.

  PMID: 24972804 BACKGROUND

• Cittadini A, Marra AM, Arcopinto M, Bobbio E, Salzano A, Sirico D, Napoli R, Colao A, Longobardi S, Baliga RR, Bossone E, Sacca L. Growth hormone replacement delays the progression of chronic heart failure combined with growth hormone deficiency: an extension of a randomized controlled single-blind study. JACC Heart Fail. 2013 Aug;1(4):325-330. doi: 10.1016/j.jchf.2013.04.003. Epub 2013 Aug 5.

  PMID: 24621936 BACKGROUND

• Smart NA, Dieberg G, Giallauria F. Intermittent versus continuous exercise training in chronic heart failure: a meta-analysis. Int J Cardiol. 2013 Jun 20;166(2):352-8. doi: 10.1016/j.ijcard.2011.10.075. Epub 2011 Nov 17.

  PMID: 22100179 BACKGROUND

• Dickstein K, Cohen-Solal A, Filippatos G, McMurray JJ, Ponikowski P, Poole-Wilson PA, Stromberg A, van Veldhuisen DJ, Atar D, Hoes AW, Keren A, Mebazaa A, Nieminen M, Priori SG, Swedberg K; ESC Committee for Practice Guidelines (CPG). ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the Task Force for the diagnosis and treatment of acute and chronic heart failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM). Eur J Heart Fail. 2008 Oct;10(10):933-89. doi: 10.1016/j.ejheart.2008.08.005. Epub 2008 Sep 16. No abstract available.

  PMID: 18826876 BACKGROUND

• Mann DL. Mechanisms and models in heart failure: A combinatorial approach. Circulation. 1999 Aug 31;100(9):999-1008. doi: 10.1161/01.cir.100.9.999. No abstract available.

  PMID: 10468532 BACKGROUND

• Jankowska EA, Biel B, Majda J, Szklarska A, Lopuszanska M, Medras M, Anker SD, Banasiak W, Poole-Wilson PA, Ponikowski P. Anabolic deficiency in men with chronic heart failure: prevalence and detrimental impact on survival. Circulation. 2006 Oct 24;114(17):1829-37. doi: 10.1161/CIRCULATIONAHA.106.649426. Epub 2006 Oct 9.

  PMID: 17030678 BACKGROUND

• Doehner W, Rauchhaus M, Ponikowski P, Godsland IF, von Haehling S, Okonko DO, Leyva F, Proudler AJ, Coats AJ, Anker SD. Impaired insulin sensitivity as an independent risk factor for mortality in patients with stable chronic heart failure. J Am Coll Cardiol. 2005 Sep 20;46(6):1019-26. doi: 10.1016/j.jacc.2005.02.093.

  PMID: 16168285 BACKGROUND

• Taegtmeyer H. Cardiac metabolism as a target for the treatment of heart failure. Circulation. 2004 Aug 24;110(8):894-6. doi: 10.1161/01.CIR.0000139340.88769.D5. No abstract available.

  PMID: 15326079 BACKGROUND

• Anker SD, Chua TP, Ponikowski P, Harrington D, Swan JW, Kox WJ, Poole-Wilson PA, Coats AJ. Hormonal changes and catabolic/anabolic imbalance in chronic heart failure and their importance for cardiac cachexia. Circulation. 1997 Jul 15;96(2):526-34. doi: 10.1161/01.cir.96.2.526.

  PMID: 9244221 BACKGROUND

• Caminiti G, Volterrani M, Iellamo F, Marazzi G, Massaro R, Miceli M, Mammi C, Piepoli M, Fini M, Rosano GM. Effect of long-acting testosterone treatment on functional exercise capacity, skeletal muscle performance, insulin resistance, and baroreflex sensitivity in elderly patients with chronic heart failure a double-blind, placebo-controlled, randomized study. J Am Coll Cardiol. 2009 Sep 1;54(10):919-27. doi: 10.1016/j.jacc.2009.04.078.

  PMID: 19712802 BACKGROUND

• Iellamo F, Manzi V, Caminiti G, Vitale C, Castagna C, Massaro M, Franchini A, Rosano G, Volterrani M. Matched dose interval and continuous exercise training induce similar cardiorespiratory and metabolic adaptations in patients with heart failure. Int J Cardiol. 2013 Sep 10;167(6):2561-5. doi: 10.1016/j.ijcard.2012.06.057. Epub 2012 Jul 4.

  PMID: 22769574 BACKGROUND

• Caminiti G, Iellamo F, Manzi V, Fossati C, Cioffi V, Punzo N, Murugesan J, Volterrani M, Rosano G. Anabolic hormonal response to different exercise training intensities in men with chronic heart failure. Int J Cardiol. 2014 Oct 20;176(3):1433-4. doi: 10.1016/j.ijcard.2014.08.040. Epub 2014 Aug 13. No abstract available.

  PMID: 25150472 BACKGROUND

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Carlo Vigorito, MD

  Federico II University of Naples

  STUDY DIRECTOR

Central Study Contacts

Francesco Giallauria, MD, PhD

CONTACT

+39081746; giallauria@libero.it

Antonello Cittadini, MD, PhD

CONTACT

+39081746; cittadin@unina.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 17, 2014
• First Posted: December 22, 2014
• Study Start: January 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2019
• Last Updated: August 1, 2017

Record last verified: 2017-07

Locations

IT (1)