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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03183323
Other study ID # LH2017_HOPE4HF
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 8, 2017
Est. completion date February 28, 2021

Study information

Verified date April 2022
Source Helse Nord-Trøndelag HF
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date February 28, 2021
Est. primary completion date February 28, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Behavioral:
Telerehabilitation
Activity trackers. Mio Slice is worn through the whole study. Actigraph is worn for one week, at 4 different timepoints through the study.

Locations

Country Name City State
Norway St. Olav University Hospital Trondheim

Sponsors (3)

Lead Sponsor Collaborator
Helse Nord-Trøndelag HF Norwegian University of Science and Technology, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Other Differences in heart failure presentation associated with co-morbid chronic kidney disease. Evaluated by cardiac imaging. Baseline.
Other The association of cardiac fibrosis with cardiorenal syndrome Evaluated by echo cardiography and/or cardiac MRI including T1 mapping. Baseline
Other Feasibility of telerehabilitation Assessment of the proportion of completed telerehabilitation programs 6 months.
Other Validation of the Mio Slice as a scientific activity tracker. Comparison of data from the Mio Slice with reference to validate it as a scientific tool for monitoring heart failure patients 6 months
Other Urine metabolomics Associated With heart failure phenotypes. Comparing traits in urine metabolomics between participants with and without chronic kidney disease. Comparing with earlier studies of patients with chronic kidney disease and healthy controls. Baseline.
Other Long-term changes in urine metabolomics after intervention. Looking for changes in metabolomics expression caused by exercise. 2 years.
Other Cost-effectiveness of telerehabilitation Vs. outpatient rehabilitation 1 years.
Other Change in physical fitness Evaluate short-term effect of telerehabilitation on measurements of physical fitness 6 months
Other The influence of cardiorenal characteristics on training effect Evaluate if cardiorenal characteristics influence on change in peak oxygen consumption of training 6 months
Other Do renal function modulate the training effect on cardiac remodeling Evaluate if renal function modulate the training effect on changes in cardiac characteristics 12 months
Other Change in short-term quality of life. Patient reported outcomes after training intervention 6 months
Primary Improvement in long-term physical activity. Change in physical activity between intervention and control group measured throughout the study with Actigraph activity trackers from baseline to 2 years. 2 years
Secondary Changes in cardiac structure and function. Echocardiographic indices - improvements from exercise. 2 years.
Secondary Change in physical fitness. The change in physical fitness at from baseline to 2 years follow-up. 2 years
Secondary Effects on renal function. Changes in renal function (GFR/proteinuria) by exercise. 2 years.
Secondary Long-term effects on cardiovascular risk factors. Blood measurements of Cardiac risk factors. 2 years.
Secondary Effects on endothelial function. Changes in peripheral arteries measured by vascular ultrasound from baseline to two years follow-up.. 2 years.
Secondary Change in long-term quality of life. Measured via validated questionnaires at different point during follow-up. 2 years.
Secondary Mid-term morbidity Evaluate morbidity as hospitalization of cardiovascular causes 2 years
Secondary Mid-term mortality Mortality during follow-up 2 years
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