Clinical trial NCT03183323: Implementation of Telerehabilitation In Support of HOme-based Physical Exercise for Heart Failure
Official title: Implementation of Telerehabilitation In Support of HOme-based Physical Exercise for Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure, Systolic
Heart Failure, Diastolic
Chronic Kidney Diseases
Cardiorenal Syndrome
Keywords: hfpef
hfref
cardiorenal syndrome
exercise
telerehabilitation
rehabilitation
Lead sponsor: Helse Nord-Trøndelag HF
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
name: St. Olavs Hospital
First posted: 2017-06-12
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT, 1:1 into telerehabilitation or standard care. Patients will be stratified by EF \>/\< 40 %, age \>/\< 60 years and by sex.
Primary purpose: TREATMENT

Brief summary: ITISHOPE4HF is a randomized controlled trial of telerehabilitation in a heart failure population. The goal is to evaluate if a home-based telerehabilitation project can increase physical activity in heart failure patients. Patients will be provided telerehabilitation or advice on physical activity (standard care).

Detailed description: Outpatient cardiac rehabilitation programs are well documented as an important part of treatment and care for heart failure patients. Training with instruction gives the participant a commitment to participate. The result is increased activity compared to controls.

This trial will include participants from the about 75 % of heart failure patients who for some reason do not participate in regular outpatient rehabilitation. Distance to rehabilitation centers and the psychological burden of a group setting are believed to be important reasons for not participating. Telerehabilitation can hopefully overcome these hurdles for many patients, and thereby provide instructed training for these patients.

The trial will also include patients with renal disease. Heart disease is the main cause of death in patients with renal disease, even at younger ages. Because of the complexity of both optimal medical treatment and fluid balance, these patients are often not included in clinical trials. The cardiorenal crosstalk will be explored, how in influence the heart failure phenotypes and the response to exercise.

Eligibility criteria: Inclusion Criteria:

* Heart failure (HFpEF or HFrEF) according to European guidelines.
* Moderate or severe signs and symptoms of heart failure (NYHA II-III) in the 6 months prior to enrolment.
* N-terminal pro brain natriuretic peptide (NT-proBNP) \> 300 pmol/L.
* Stable (\> 4 weeks) medical therapy for risk factor control.
* Capability to provide signed, informed, written consent.

Exclusion Criteria:

* Attendance at a rehabilitation program in the 6 months prior to enrolment.
* Non-heart failure causes of heart failure symptoms (significant valvular disease, coronary disease available for revascularization, uncontrolled hypertension, arrhythmia).
* severe or very severe pulmonary disease (eg. COPD GOLD III-IV).
* presence of conditions which might prevent patients from safely exercising at home.

Primary outcomes:
measure: Improvement in long-term physical activity.
timeFrame: 2 years
Secondary outcomes:
measure: Changes in cardiac structure and function.
timeFrame: 2 years.
measure: Change in physical fitness.
timeFrame: 2 years
measure: Effects on renal function.
timeFrame: 2 years.
measure: Long-term effects on cardiovascular risk factors.
timeFrame: 2 years.
measure: Effects on endothelial function.
timeFrame: 2 years.
measure: Change in long-term quality of life.
timeFrame: 2 years.
measure: Mid-term morbidity
timeFrame: 2 years
measure: Mid-term mortality
timeFrame: 2 years
Other outcomes:
measure: Differences in heart failure presentation associated with co-morbid chronic kidney disease.
timeFrame: Baseline.
measure: The association of cardiac fibrosis with cardiorenal syndrome
timeFrame: Baseline
measure: Feasibility of telerehabilitation
timeFrame: 6 months.
measure: Validation of the Mio Slice as a scientific activity tracker.
timeFrame: 6 months
measure: Urine metabolomics Associated With heart failure phenotypes.
timeFrame: Baseline.
measure: Long-term changes in urine metabolomics after intervention.
timeFrame: 2 years.
measure: Cost-effectiveness of telerehabilitation
timeFrame: 1 years.
measure: Change in physical fitness
timeFrame: 6 months
measure: The influence of cardiorenal characteristics on training effect
timeFrame: 6 months
measure: Do renal function modulate the training effect on cardiac remodeling
timeFrame: 12 months
measure: Change in short-term quality of life.
timeFrame: 6 months
Locations:
city: Trondheim
country: Norway
facility: St. Olav University Hospital
Study officials:
affiliation: Norwegian University of Science and Tehnology
name: Havard Dalen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: