Effect of ACE Genotype on Cardiovascular Rehabilitation (ACE-REHAB)

Balgrist University Hospital

Status and phase: Terminated; Phase 2

Conditions: Cardiovascular Disease

Treatments: Genetic: ACE genotyping; Behavioral: concentric cardiovascular training; Behavioral: eccentric cardiovascular training

Study type: Interventional

Funder types: Other

Identifiers

NCT02845063

W 549 ACE-REHAB

KEK-ZH-Nr. 2014-0319 (Other Identifier)

Details and patient eligibility

About

The study aims to systematically investigate the interaction between training modality, ACE genotype and disease in heart patients whom complete a cardiovascular rehabilitation program. This is carried out with the goal to improve the benefit of cardiovascular rehabilitation for the patient by maximising adjustments in muscle structure and function with the intervention. A population of healthy individuals will be recruited who will carry out the same training program, in order to compare the training effects respective to the general population.

Full description

Pharmacological inhibition of angiotensin converting enzyme modifies exercise-induced pro-angiogenic and mitochondrial gene transcript expression. Exercise-induced muscle plasticity importantly interacts with the insertion/deletion genotype of ACE and the training modality and intensity. The aim of this study is to systematically investigate the interaction between training modality, ACE genotype and disease in heart patients whom complete a cardiovascular rehabilitation program.

There are two training modalities being used: The first modality involves cardiovascular training by an interval type of protocol that includes a high repetition number of shortening (i.e. concentric) type contractions on a softrobotic device. The second modality includes a high repetition number of lengthening (i.e. eccentric) type contractions on a softrobotic device. In both training modalities the same muscle groups are exercised over the same range of motion, with the same speed of movement, but with widely differing pedal force. Total absolute external mechanical work will be matched.

In order to assess the baseline values and the effect size of the muscle and training adjustments made, healthy male and female volunteers will be included who are matched with respect to age and sex to the patient population and undergo the same training program.

Enrollment: 60 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Patient group inclusion criteria:

• stable coronary heart patients/heart patients without ischemia
• Left ventricular ejection fraction > 50%
• Drug therapy with ACE inhibitors
• V̇O2peak <86% of the medical reference value Voluntary participation
• Written informed consent of the subject to participate in the study

exclusion criteria:

• relevant valvular heart disease
• arterial hypertension (blood pressure at rest> 140/90)
• arrhythmogenic cardiomyopathy
• ACE inhibitor intolerance
• contraindication for ethical reasons
• known or suspected non-compliance with the curriculum
• smoker
• drug or alcohol disease
• inability of the patient to follow the study procedures (e.g. because of language problems, mental illness, dementia)
• participation in another clinical trial within the last 30 days prior to confinement and during the study
• other, clinically significant comorbidities (cardiac arrhythmia, renal insufficiency, hepatic dysfunction, connective tissue disease [Marfan syndrome, Ehlers-Danlos syndrome])

Healthy subject group inclusion criteria:

• inconspicuous ECG under exercise (persons in whom the exercise ECG is abnormal will be referred for a cardiological evaluation recessed to the University Hospital Zurich)
• V̇O2peak <50 ml O2 min-1 kg-1
• Voluntary participation
• Written informed consent of the subject to participate in the study

exclusion criteria:

• relevant valvular heart disease
• arterial hypertension (blood pressure at rest> 140/90)
• arrhythmogenic cardiomyopathy
• ACE inhibitor intolerance
• contraindication for ethical reasons
• known or suspected non-compliance with the curriculum
• smoker
• drug or alcohol disease
• inability of the patient to follow the study procedures (e.g. because of language problems, mental illness, dementia)
• participation in another clinical trial within the last 30 days prior to confinement and during the study
• other, clinically significant comorbidities (cardiac arrhythmia, renal insufficiency, hepatic dysfunction, connective tissue disease [Marfan syndrome, Ehlers-Danlos syndrome])

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

concentric cardiovascular rehabilitation

Experimental group

Description:

Heart patients under ACE inhibitor intake will be enrolled in the intervention 'concentric cardiovascular training' and evaluated by the intervention 'ACE genotyping'

Treatment:

Genetic: ACE genotyping

Behavioral: concentric cardiovascular training

eccentric cardiovascular rehabilitation

Experimental group

Description:

Heart patients under ACE inhibitor intake will be enrolled in the intervention 'eccentric cardiovascular training' and evaluated by the intervention 'ACE genotyping'

Treatment:

Genetic: ACE genotyping

Behavioral: eccentric cardiovascular training

concentric cardiovascular training

Active Comparator group

Description:

Healthy subjects will be enrolled in the intervention 'concentric cardiovascular training' and evaluated by the intervention 'ACE genotyping'

Treatment:

Genetic: ACE genotyping

Behavioral: concentric cardiovascular training

eccentric cardiovascular training

Active Comparator group

Description:

Healthy subjects will be enrolled in the intervention 'eccentric cardiovascular training' and evaluated by the intervention 'ACE genotyping'

Treatment:

Genetic: ACE genotyping

Behavioral: eccentric cardiovascular training