High-intensity Interval Training in Heart Failure Patients With Preserved Ejection Fraction

NCT ID: NCT03184311

Last Updated: 2023-02-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2023-03-31

Brief Summary

This study investigates the effects of a 12-week high-intensity interval training (HIT) on exercise tolerance, functional status and quality of life in patients with chronic heart failure with preserved ejection fraction (HFpEF), in comparison to a control group undergoing a 12-week moderate-intensity continuous training.

Detailed Description

Heart failure (HF) with preserved ejection fraction (HFpEF) occurs in about 50% of all HF patients. Remodeling and fibrosis stimulated by inflammation appear to be main factors for the progression of HFpEF. The lack of prognostic treatment options in HFpEF urgently calls for new therapeutic approaches. While beneficial effects of exercise training have been demonstrated in HF with reduced ejection fraction, they have not yet been evaluated in HFpEF. Therefore, the aim of this study is to investigate the effects of high-intensity interval training (HIT) in HFpEF patients.

The proposed study will be a prospective, single-blind, randomized controlled trial in a primary care setting including 86 patients with stable HFpEF. Patients will undergo 3 study visits (a screening visit, a baseline visit and a post-intervention visit) including measurements of disease-specific biomarkers (using blood samples), cardiac and arterial vessel structure and function (using electrocardiogram, echocardiography, pulse wave velocity, flow-mediated dilation, retinal vessel analysis, cold pressure test), exercise tolerance (using spiroergometry), muscle function (using near-infrared spectroscopy, muscle strength tests), habitual physical activity (using accelerometry) and QoL. After the baseline visit, patients will be randomized to either the intervention or control group. The intervention group (n=43) will attend a supervised 12-week HIT on a bicycle ergometer, while the control group (n=43) will attend a supervised 12-week moderate-intensity continuous training (MCT). After 12 weeks, the study measurements will be repeated in all patients (intervention and control group) in order to monitor the effects of the intervention (post-intervention visit). At 6 months, 1, 2 and 3 years after the last study visit, telephone interviews will be performed to assess medical outcomes and QoL.

Outlook: This study is expected to add important knowledge about the potential utility of a novel treatment strategy in HFpEF patients, which may help to improve both, QoL and functional status. Moreover, the analysed biomarkers might be able to provide further insight into prognosis and pathogenesis of HFpEF.

Conditions

Heart Failure With Normal Ejection Fraction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

High-intensity interval training (HIT)

A 12-week HIT will be performed 3 times per week on a bicycle ergometer according to the protocol of Wisløff et al. In the first 4 weeks of the program, all sessions will consist of moderate continuous training (MCT) at 60-80% of peak heart rate (HRpeak) for 40 minutes in order that patients get used to exercising. For weeks 4-12, the following HIT protocol is intended: Patients will warm up for 10 minutes at moderate intensity (60-70% of HRpeak, Borg 11-13) before cycling four 4-minute intervals at high intensity (85-95% of HRpeak, Borg 15-17). Each interval will be separated by a 3-minute active pause at 60-70% of HRpeak (Borg 11-13). The training session will end with a 5-minute cool-down at moderate intensity (60-70% of HRpeak). Total exercise time will be 40 minutes.

Group Type: EXPERIMENTAL

High-intensity interval training (HIT)

Intervention Type: OTHER

Supervised 12-week HIT 3 times per week on a bicycle ergometer.

Moderate-intensity continuous training (MCT)

A 12-week MCT will be performed 3 times per week on a bicycle ergometer. All sessions will consist of moderate continuous training (MCT) at 60-70% of peak heart rate (HRpeak) for 47 minutes.

Group Type: PLACEBO_COMPARATOR

Moderate-intensity contiuous training (MCT)

Intervention Type: OTHER

Supervised 12-week MCT 3 times per week on a bicycle ergometer.

Interventions

High-intensity interval training (HIT)

Supervised 12-week HIT 3 times per week on a bicycle ergometer.

Intervention Type: OTHER

Moderate-intensity contiuous training (MCT)

Supervised 12-week MCT 3 times per week on a bicycle ergometer.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Informed consent as documented by the patient's signature
• NYHA functional classes II-III
• Signs and symptoms of chronic HF:

• Dyspnea, paroxysmal nocturnal dyspnea
• Reduced exercise capacity, extended recovery after exercising
• Fatigue
• Peripheral edema (lower leg, ankle)
• EF (Ejection fraction) >50%
• Structural or functional changes in echocardiography:

• LAVI (left atrial volume index) >34 ml/m2 OR
• LVMI (left ventricular mass index) >115 g/m2 (men), >95 g/m2 (women) OR
• E/E' (ratio between mitral peak velocity of early filling (E) to early diastolic mitral annular velocity (E')) >13 AND mean E' septal and lateral wall <9 cm/s
• NT-proBNP >125 pg/ml
• At least 4 weeks on stable medical treatment or without signs and symptoms of cardiac decompensation
• Trainable: Ventilatory threshold >40% of predicted VO2max AND VO2peak >10 ml/kg/min at the screening visit

Exclusion Criteria

• Planned cardiac interventions in the following 6 months
• Unstable angina pectoris
• Paroxysmal atrial fibrillation
• Severe uncorrected valvular heart disease
• Uncontrolled brady- or tachyarrhythmia and hypertonic blood pressure
• Clinically significant concomitant disease states (e.g. advanced renal failure, hepatic dysfunction, insulin-dependent diabetes, COPD (chronic obstructive pulmonary disease) in grades III-IV, on-going cancer treatment)
• Significant musculoskeletal disease limiting exercise tolerance
• Active infection
• Immunosuppressive medical therapy
• Earlier hypersensitivity to parenteral iron preparation
• Anemia and iron deficiency due to active and/or chronic bleeding
• Blood transfusion within the previous 30 days
• Vulnerable persons (age <18 years, pregnant and breastfeeding women)
• Known or suspected non-compliance, drug or alcohol abuse
• Inability to follow the study procedures due to insufficient language skills, psychological disorders, dementia, etc.
• Participation in another intervention study
• Life-expectancy <6 months

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinical Trial Unit, University Hospital Basel, Switzerland

OTHER

Sponsor Role: collaborator

University of Basel

OTHER

Sponsor Role: lead

Responsible Party

Arno Schmidt-Trucksäss

Clinical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arno Schmidt-Trucksäss, MD

Role: PRINCIPAL_INVESTIGATOR

University of Basel

Thomas Dieterle, MD

Role: PRINCIPAL_INVESTIGATOR

University of Basel

Locations

Department for Sport, Exercise and Health, Section Sports and Exercise Medicine, University of Basel

Basel, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Arno Schmidt-Trucksäss, MD

Role: CONTACT

arno.schmidt-trucksaess@unibas.ch

+41 61 2074741

Thomas Dieterle, MMed

Role: CONTACT

thomas.dieterle@unibas.ch

Facility Contacts

Arno Schmidt-Trucksäss, Prof. Dr.

Role: primary

arno.schmidt-trucksäss@unibas.ch

+41(0)612074741

Thomas Dieterle, Prof

Role: backup

thomas.dieterle@unibas.ch

References

Gasser BA, Boesing M, Schoch R, Brighenti-Zogg S, Kropfl JM, Thesenvitz E, Hanssen H, Leuppi JD, Schmidt-Trucksass A, Dieterle T. High-Intensity Interval Training for Heart Failure Patients With Preserved Ejection Fraction (HIT-HF)-Rational and Design of a Prospective, Randomized, Controlled Trial. Front Physiol. 2021 Sep 24;12:734111. doi: 10.3389/fphys.2021.734111. eCollection 2021.

Reference Type: DERIVED

PMID: 34630155 (View on PubMed)

Other Identifiers

2019-00188

Identifier Type: -

Identifier Source: org_study_id